FranklinStephen1973

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California State University, Northridge
I!
LAMINARIA REDUCES TIME OF SALINE AMNIOCENTESIS ABORTION
\\
A thesis submitted in partial satisfaction of the
requirements for rhe degree of Master of Science in
Health Science
by
Stephen L. £_ranklin
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August, 1973
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The thesis of Stephen L. Franklin is approved:
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California State University 1 Northridge
August 1 1973
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TABLE OF CONTENTS
PAGE
v
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ACKNOWLEDGMENTS ..................... ~ ................. .
vi
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ABSTRACT. ...•.........•..............•...............••.....
vii
LIST OF TABLES ••••••••••.••.•
.................................
CHAPTER.• .•.•..••. ·.................•.......................•..
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Hi story. ............. .
Purpose of the Study .....••••••.
Statement of the Hypothesis ......
Definition of Terms for the Purpose of the Study .•
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3
7
9
10
10
MATERIALS AND METHODS
19
19
24
RESULTS
Analysis of Data •..••
Statistics Presentation.
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3
13
18
Description of Population ....
Plan for Statistical Analysis.
Additional Procedures .•. ~ .•
IV
1
LITERATURE REVIEW
Discussion ..
Summary .•
26
27
SUMMARY AND CONCLUSIONS
32
33
Summary. •••
Conclusions
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INTRODUCTION
General ••
Need •••••
Procedura I Description •
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BIBLIOGRAPHY ......•..................... : ....... ~ .......... .
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APPEND IX ••••••••••••••••••••••••••••••••••••••••••••••••••••
38
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Exhibit of
Inglewood
Inglewood
Inglewood
Inglewood
lnvestigator•s Raw Data Recap •.•••••••••••••••
General Hospital 1s Medical Chart Front Sheet ••.
General Hospital's Patient Clinical History Form.
General Hospital•s Progress Record •.•••••••••••
General Hospital•s Nurse•s Notes 1 p 11 2 & 3 ••••
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43
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LIST OF TABLES
PAGE
TABLE
Types of Abortion Procedures
II
Inglewood General-Hospital Saline Amniocentesis Patient's
Gravidas, September 14, 1972 to May 31, 1973 and the
Mean Time of Infusion to Expulsion of the Fetus
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Number of Laminaria Inserted at Inglewood General Hospital
into Saline Amniocentesis Patients from September 14, 1972
to May 31, 1973 and the Mean Time of lnfusi on to Fetus
21
Expulsion
IV
Weeks Gestation of Inglewood General Hospital Saline
Amniocentesis Patients from September 14, 1972 to May 31,
1973 and the Mean Time of Infusion to the Expulsion of the
Fetus.
22
Age of the Saline Amniocentesis Patients at Inglewood
General Hospital from September 14, 1972 to May 31,1973
and the Mean Time of Infusion to Expulsion of the Fetus
23
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VI
Statistical Summary on 11 F 11 Test on the Use of Laminaria
Related to Time Reduction from Time of Infusion to Expulsion
of Fetus on Saline Amniocentesis Patients
28
VII
Analysis of Variance for the Multiple Linear Regression on
the Use of Laminaria Related to Time Reduction from Time of
Infusion to Time of Expulsion of Fetus in the Saline Amnio29
centesis Patient
VIII
IX
Analysis of Variance for Multiple Linear Regression on Age
Related to Time Reduction from Time of Infusion to Time of
Expulsion of Fetus in the Saline Amniocentesis Patient
30
Analysis of Variance for Multiple Linear Regression in Relation to Patient Gravida Related to Time Reduction from Time
of Infusion to Time of Expulsion of the Fetus in the Saline
31
Amniocentesis Patient
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ACKNOWLEDGMENTS
My deep appreciation to Dr. Donald M •.Hufhines for his continual
advise and support in the development of this thesis.
Sincere appreciation is extended to Dr. John Fodor for serving as a
member of the Thesis Committee.
The author wishes to thank Morton W. Barke, M.D., for his technical
assistance.
The author also wishes to acknowledge Mr. James Aldrich, Mr. Patrick
'·
McGuire and Mrs. Barbara Ann Dennis for their help.
Special appreciation goes to Mrs. Norma C. Arseneau, who spent
endless hours in typing and assisting in the preparation of this thesis.
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ABSTRACT
LAMINARIA REDUCES TIME OF SALINE AMNIOCENTESIS ABORTION
by
Stephen L. Franklin
Master of SCience in Health Science
August, 1973
A seaweed extract called laminaria is now being inserted into the cervix
of saline amniocentesis abortion patients at Inglewood General Hospital. Recent ·j
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studies of dilatation and suction curettage abortions have proven that laminaria
has two major benefits: the first benefit being the safety application in pre.:.
serving the patient's child-bearing capability, and the second being that it
enables the procedure to be performed more easily.
An additional major benefit, that of a reduction of patient time in the
saline amniocentesis abortion procedure was hypothesized by the author. If
this was truE} patients would benefit economically and in the amount of hours
spent in labor - "patient trauma time".
A plan for statistical analysis was designed by the author, designating
four factors as possible contributors to the differences in the total amount of
time between the infusion of saline and the time of fetal expulsion.
These
factors were the use of laminaria, the weeks of gestation, the gravidas, and
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. ----·1
r the p.atienes age. For the purpose of this study the medical records of 1, 114 I
-···-··----·---···-·-------------·-·-------···--.-~---
patients at Inglewood General Hospital were reviewed. Statistical analysis
of the data indicated that only laminaria was significant in the reduction of
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time, and that the time could be reduced even more proportionate to the
number of additional laminaria inserted into the cervix.
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viii
CHAPTER I
INTRODUCTION
General
One of the major problems that the obstetrician-gynecologist faces on a
day-to-day basis is the obstruction of the cervix uteri. Numerous materials
and methods have been used in trying to open the cervix, i.e., lubrication,
heat application, injection, vibration, anesthesia, narcotics, hormonization
and shocks. ( 1)
A method of dilating the cervix that has been used at Inglewood General
Hospital, Inglewood, California, is the laminaria, also known as the laminaria
tent. The laminaria is made from laminaria digitata which is a type of seaweed
that is predominantly found in cold ocean waters. The laminari a is approximately 60 mm. long and varies in thickness from extra thin at 2 mm. to thick
at 5 mm.
Inglewood General Hospital began to specialize in abortions in August,
1972. The types of abortion performed at this hospital are dilatation and
suction curettage, that is for a pregnancy up to 12 to 14 weeks, and the saline
amniocentesis abortion that is for a pregnancy that is evaluated by the obstetrician to be too dangerous to have the dilatation and suction curettage and is
I not more than 20 weeks gestation, as required by California State Law(2) re-
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quirements, pertinent to abortion.
Inglewood General Hospital is one of approximately five accredited
general hospitals in the State of California that has specialized in abortions
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and tubal ligations, with a patient load exceeding one thousand cases per
month. The hospital services the major portion of the Planned Parenthood and
the National Family Planning agencies• referrals. The patients fi II the spectrum os to general factors, such as race, ethnic origin, economics, religion,
3
health education, general attitudes ond health practices. ( )
Unti I the latest United States Supreme Court Decision (4 ) handed down on
January 22, 1973, there were only a few states that had liberal abortion laws.
Because of this, Inglewood General Hospital 1 s patients come from all over the
Western United States, with the majority from California, Arizona and Texas.
On September 14, 1972, laminarias were inserted into some pregnant
women who were to hove abortions done by dilatation and suction curettage or
by saline amniocentesis. It became evident that the laminaria eased the
surgical procedure for the dilatation and suction curettage; however, the time
factor involved in the procedure and the patient•s stay in the hospital was not
materially affected as the normal stay is approximately four hours. However,
in the saline amniocentesis procedure in which the patient•s labor is induced,
the time factor of patienes stay appeared to be materially reduced, thus
affecting a reduction of patient trauma time and a probable reduction of dollar
costs to the hospital. This reduction of patient time is the subject of my
hypothesis.
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Need
The liberalization of abortion laws has propelled the development of the
obstetrician•s technique. The introduction of the laminaria as part of the saline
amniocentesis procedure at Inglewood General Hospital appears to be a vital
contribution. With the great increase in the number of abortions being performed in the United States, technical advancements have added significance.
Saline amniocentesis procedures are currently averaging between 10 and 30 per5
cent of the total abortion procedures in various programs around the Country} )
(See Table 1). The variance would seem to be due to health education, local
attitudes and demographics, basically all affecting how early the pregnant
female decides her pregnancy is unwanted.
An important consideration is that the abortion patient is normally a
young girl with childbearing plans for the future, as compared with the older
female who is di Ia ted for a diagnostic or therapeutic curettage. The young
abortion patient faces the possible danger of impairment to· her reproductive
capability. Thus the greatest effort must be made to use the best technique in
dilating the cervix.
Procedural Description
The description of the saline amniocentesis procedure at Inglewood
General Hospital is as follows:
The patient is taken to the Examining Room, and bimanual examination
is carried out by the physician to rule out adnexal masses, and to locate the
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TABLE I
TYPES OF ABORTION PROCEDURES
Inglewood
General Hospital
*A Major New
York Hospital
*New York State
Abortion Clinic
Saline Amniocentesis
10.4%
23.%
30.6%
Dilatation and Suction Curettage
89.5%
65.%
64.5%
Dilatation and Curettage - Standard
-0-
8.%
3.1%
Other
.1%
4.%
1.8%
Total
100.0% -
100.0%
100.0%
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*(5)
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uterus in the pelvic floor. A sterile laminaria is then manually grasped at it 1 s
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distal end and inserted into the internal os of the cervix, leaving the strings
which are attached to the laminaria, remaining in the vaginal area for easy
removal of the laminaria. Following this, the abdomen is thoroughly prepped
with Betadine and draped in the usual manner. Using sterile technique a 20
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gauge by 3 1/2 11 spinal needle is introduced through the abdomen into the uterus.;
Upon perforating the uterine wall, the physician will aspirate 3 to 5 cc. of
amniotic fluid, to confirm perforation of the uterus and not of the underlying
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viscus. Following this, the physician will infuse approximately 200 cc. of
hypertonic saline solution into the uterus. The patient is then taken to her
hospital room for complete bed rest, except for bathroom privileges with assistonce. During this time, the following occurs: The saline solution being of
high concentration, causes the fetal cells to collapse through osmosis, thus
destroying the cytoplasm of the cells and the gross destruction of the fetal
tissues in general. After the destruction of the fetal tissues, the patient•s
physiological system will start the process of labor to expel the dead tissues.
At the onset of labor, Oxytocin is administered to the patient to help in the
expulsion of the fetus and placenta.
The obstetrician while inserting the laminaria does the following:
1•
Notes the size and the position of the uterus while making the
pelvic examination.
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With the vaginal speculum in place, thoroughly cleanses the
vagina and the cervix with antiseptic solution.
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3.
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Cleanses the endocervical canal with a swab coated with a suitable l
cervical medication (cream or jelly), which acts as a lubricant.
4.
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Sounds the cervical canal for patency; sound must pass easily through
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the internal os. The obstetrician notes:
5.
a.
the direction of the canal
b.
spast-icity of the internal os
c.
presence qf false passages,
Grasps the laminaria at the string end for placement in the endocervical canal.
6.
Coats the laminaria with a suitable cervical medication. (See #3
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above).
7.
Inserts the laminaria unti I only 5 mm. protrudes from the external
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os. The attached string should rest in the vaginal vault for easy
removal. He makes certain that the laminari a traverses the internal
and external os for proper dilatation of these sites.
8.
A suitable cervical medication (see #3 above), should be applied
over the cervix and the tip of the laminaria.
.
It should be noted that at higlewood General Hospital only four physicians
performed the saline amniocentesis procedure from Sepi·ember 14, 1972 through
May 31, 1973. It should also be emphasized that in the saline amniocentesis
procedure as described, and including the laminaria insertion, there is little
room for procedure de vi ati on.
Inglewood General Hospital
li~ited
it's usage of laminaria to two major
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I brands:
Berkeley and Milex. These
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laminaria~ are manufactured in Japan.
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The sizes used for the saline amniocentesis procedure were both the small and
the medium, with the majority being medium, approximately 3 mm. The
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steri Iizati on technique performed by the manufacturers is Ethylene Oxide. None:
of the laminaria used at Inglewood General Hospital was used a second time.
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History
Laminaria has been used in different parts of the world for centuries.
American medical publications of the 1870 era infer that laminaria usage in
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the United States was heavy. In 1869, Dr. J. Braxton Hicks ( ) wrote:
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all the materials used for dilating the cervix uteri, there are none so cleanly
efficient as those made from the laminaria digitata. Although now largely
employed by many, they are not so we II known as they deserve to ge; and
therefore, allusion to the subject may not be altogether useless, nor some
practical hints unacceptable to some readers 11 •
Elm bark was another cervical dilator of the same era. Elm bark was
made into a roll of the proper length, beaten until it was soft and dipped into
7
carbolized water, after which it would be placed into the cervix. { )
It appears that two major factors diminished the use of laminaria in the
United States by the turn of the century. These were that laminari a was
associated with abortion, and that antiseptic techniques in packaging were. not
8
adequate. ( ) By 1910 reference to laminaria had disappeared from American
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( medical publications. ( ) Thus, laminaria became a medical relic in the United
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States. However 1 laminaria continued to be used in Germany 1 Switzerland
and Japan.
After World War II, Japan, because of it's immense population problems,
liberalized abortion and the use of laminaria flourished. The use of laminaria
has been restricted, however, to the abortion procedures used in Japan, which
1
are mainly the Bougie, Metreurynter and Rivanol methods. ( 0) Hypertonic
saline is not used in Japan, as it is thought to be overly dangerous.
In describing the current method of processing and packaging, Kenneth
R. Niswander, M.D., (l 1) University of California, Davis, wrote:
Laminaria tents are made from laminaria digitate, a species of
seaweed which grows in cold ocean waters in various parts of the
world. The Japanese have one of the few sources that are both
economically accessible and uncontami noted. Seaweed growth
in warm ocean waters or plants with hygroscopic action grown on
·land have historically had a high risk of infection associated with
their use and it is probably the relatively clean, cold ocean water
that made possible the use of laminaria digitate before adequate
gas sterilization became available in the last few years.
11
The pI ant, harvested by two-man crews operating from sma II boats 1
is brought to shore and placed on drying racks as soon as possible
to prevent mold growth from developing. To facilitate drying, the
plants are frequently turned on the racks and always positioned so
that the stems will dry straight. The dried plants are hand selected
and cut to length. Each indiv.idual laminaria is shaved to smooth
the outer surface.
When packaged, the laminaria tents are about 6 em. long and from
2 to 5 mm. in diameter 1 and they have a string attached to the tip
through a hole bored in the tent. Some of the commercially available tents are flared very slightly in their shape so that one end is
slightly wider than the other.* Somer however, have an equal
diameter throughout.+ When placed in water or in tissue the laminaria tent is intensely hygroscopic and swells to three to five times
its' initial diameter. Most of the swelling apparently takes place
in the first six to eight hours 1 probably less 1 although it is said
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that the swelling continues for 24 hours. *Milex; +V.Mueller. 11
Purpose of the Study
As indicated previously, the need for an improvement in the method of
dilating the cervix is great. The liberalization of the laws governing the
abortion procedure, and the fact that the maj.ority _of patients desire childbearing in the future, should be emphasized again.
The literature review that-follows, indicates that there are two major
benefits from the use of laminaria pertaining to the dilatation and suction
curettage procedure. These are:
1.
The procedure is easier to perform on a timely basis
due to the fact that the laminaria causes the cervix
to become soft and flexible, thereby aiding the
physician and the patient.
2.
There is less chance for damage to be done to the
cervix because the maximum di lotion is attained.
The safety in the use of laminaria was proven to compare favorably with the
non-laminaria patient, in terms of hospital re-admissions, postoperative emergency room visits, fever, antibiotics used, and the total complication rate.
The insertion of one or more laminaria into the saline amniocentesis
patient derives the same two benefits mentioned above, and offers a third
benefit, thatoftime.
As was previously indicated, the time factor of the patient's stay ap-
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peared to be materially reduced.
If this were. true 1 both patient trauma time
and dollar costs would be reduced.
Statement of the Hypothesis
The null hypothesis of this study is:
The insertion of a laminaria 1 or laminarias, into the cervix causes
no difference in the amount of time between J·he infusion and the expulsion of
the fetus during the saline amniocentesis abortion procedure.
Stat-ed stati sti co II y:
In charting a trend for the use of one or more laminarias 1 the hypothesis
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would be statistically stated:
H0
true slope
=
0
H1
true slope
=I=
0
Defi ni ti on of Terms for the Purpose of the Stud/
12
&
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)
Adnexal:
Accessory parts of the uterus 1 as ovaries.
Amniocentesis:
Transabdominal perforation of the uterus, to
permit drainage of amniotic fluid.
Amnion:
The inner of the fetal membranes which holds
the fetus suspended in amniotic fluid.
Amniotic Fluid:
The fluid of the amnion.
Aspirator:
An apparatus used for removing by suction
the fl.uids or gasses from a cavity.
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Cannula:
A tube for insertion into the body, with a
cavity within the tube which is to contain
a sharp instrument.
Cervicitis:
Inflammation of the cervix.
Cervix Uteri:
The lower and na·rrow end of the uterus between the isthmus and ostium uteri.
Cytoplasm:
The protoplasm of a cell which envelops the
nucleus.
Dilatation:
Expansion of an oriface with a dilator.
End ocervi co I Can a I:
The Ii ni ng of the cervix uteri •
Gestation:
The period of development of the young in
animals from time of fertilization of the ovum.
Gravida:
A pregnant woman, co lied 1 first pregnancy,
called 2 second pregnancy, etc.
Hypertonic:
Having an osmotic pressure greater than that
of the solution with which it is compared.
Metreurynter:
An inflatable bag for dilating the cervical
canal of the uterus.
Os:
Mouth; e.g., mouth of uterus.
Oxytocin:
Hormone medication to sti mu Iate contraction
of the uterine museu lature to induce active
labor and to cause contraction of the uterus
after delivery of the placenta.
Parity:
The condition of a woman with respect to her
having borne viable offspring.
Patency:
The state of being freely open.
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Suction Curettage:
Removal of the contents of the uterus with
an aspirator.
Tenaculum:
A sharp, hooklike, pointed instrument for
grasping cmd holding a part.
Trimester:
A period of three- months.
Uterine Wall:
The wall of the uterus.
Uterus:
The hollow muscular organ in female animals
which is the abode and place of nourishment
of the embryo and fetus.
Vaginitis:
Inflammation of the vagina.
_
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CHAPTER II
LITERATURE REVIEW
Discussion
The following ways were employed in searching for literature on laminaria:
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A Medline Search.
2.
Reading the tables or contents of all major obstetrical-gynecological'
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journals, published from January, 1970 through June, 1973.
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3.
Requesting available literature from the obstetrician-gynecologists
on the Inglewood General Hospital staff.
There is not an abundance of available literature, because the liberalization of
abortion laws took place only in the last few years.
In reviewing medical literature there appears to be no study of laminaria
being used in the saline amniocentesis abortion. There has been recent literature in the dilatation and suction curettage procedure. Two comprehensive
studies· have been pub Iished.
Burritt W. Newton, M.D. (
14
) conducted a study from October 1, 1970
to August 1, 1971, at the University of Oregon Medical School Hospital. All
of the dilatation and suction curettage abortions at the subject hospital during
that time had cervical dilatation with laminaria. Five hundred consecutive
patients were selected for the study. Followup time was from two to ten months;
the average age was 22.2 years; the range was from 14 to 43 years. Parity 0
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was 67.8%; parity 1 was 13.2%; parity 2 was 9.8%; parity 3 was 5.6%;
parity 4 and 4+were3.6%. Gestation range was from two to eighteen weeks,
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and one pctient was not pregnant. Gestation of less than six weeks showed 63
patients for 12.6%; six to ten weeks showed 386 patients for 77.4%; over ten
cervical cannula-curette was accepted. Only two patients did not dilate to
this degree.
laminaria placement, however, the author stressed that the cramping usually did
· not even require aspirin.
During the study period, twelve spot checks of sterility were made. No
new organisms grew in cultures of both the new laminaria and the used laminaria
that had been re-steri lized. However, the author noted that the cultures of
used laminaria soaked in 99% alcohol grew out E. Coli in four out of five tested.
The statistics applicable to the five hundred patients in Dr. Newton's
study support the safety factor in the usage of Iami naria. The statistics can be
15
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___
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.~,..,__..---~-~-v.---....__.
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summarized as follows:
Hospital readmission
1.2%
Emergency Room visits after procedure
1.8%
Fever attributable to the laminaria or
the abortion
2.9%
Antibiotics used for fever or pelvic infection
5.2%
Total complication rate
8.0%
The author noted that the above data compared favorably with other
groups not using laminaria.
A group of obstetrician-gynecologists (
15
) conducted a study on two hun-
dred and fifty patients having abortions in the first trimester. The procedure was
the dilatation and suction curettage. The time period of the study was between
February of 1971 and August of 1971. The ages of the patients ranged from 15 to
43 years. The time of gestation varied from 4 to 14 weeks. Parity 0 was 60%;
parity 1 to 3 was 27%; parity 4 and 4+ were 13%.
The authors noted that the patients were selected at random and that
laminaria insertions were attempted in all those selected for the study- - - 11
Vaginitis, cervicitis, or a history of old upper-tract infection were not con-
sidered contraindications to laminaria insertion. 11
The laminaria had to be removed within three hours of insertion on three
patients. This was attributed to severe uterine cramping. Failure of dilation on
eight of the first one hundred patients in the study, was attributed to the belief
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that the laminaria was not inserted all the way through the internal os.
l~- <_< ««------~---·----·-··-·---"-
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- - - - - - ~- - - -
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The results noted that only two patients {0.8%) had a temperature eleva-
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tion. Both elevations were 101 to 102°F., and appeared within twelve hours
after expulsion of the fetus. Both patients were given antibiotics and temperatures were normal within twelve hours. As in the Newton(
14
) study 1 almost all
patients had mild cramping with the insertion of the laminaria. However 1 the
authors noted that this cramping was transitory and usually disappeared within
three to five minutes.
Intermittent cramping for six to eight hours after in-
sertion was mentioned by most patients.
The cervical dilation resulting from the use of the laminaria prior to the
I
I
to 11 mm. - 68%; 12 and 12+ mm. - 27%. The authors concluded that -I
We believe that the laminaria tent can be an extremely useful adjunct to the
I
therapeutic abortion by uterine aspiration. When properly used the tent appears!
dilatation and suction curettage procedure was noted as 8 to 9 mm. - 5%; 10
11
1
to pose no significant hazard to the patient. 11
A less comprehensive study by Doctor Manabe 1 (1 6 ) focused on the safety
..
of using the laminaria tent for cervical dilatation. The author stated that:
11
I
I
. I
I
!
Laminaria tents are used for the following conditions: {1) dilatation
of the cervix which is too narrow and stiff to be dilated sufficiently
at one time as sometimes en·countered in young primigravidas even in the
second and third gestational months, {Weeks 5 to 12). Under anesthesia
and after thorough disinfection of the vagina, the cervix is very carefully dilated to a certain extent, and one or two narrow tents are inserted side by side. One-step artificial abortion is performed on the
following day. {2) Dilatation of the cervix, in either primi- or multi.gravidas, in the early fourth gestational month, (Weeks 13 and 14).
Following cervical dilatation by Hegar dilators up to Nos. 12 to 16,
2 or 3 tents are inserted into the cervix. On the following day, after
further dilatation of the cervix by Hegar dilators {No. 20 or more, if
necessary), one-step evacuation of the uterine contents is performed.
I
I
I
17' -.
--------·----~-------·----~--- ·--_----------------···-------·--·----~---
·-----.----·· · ---
.
---------·--~----- ---·----------------~1
The suction method is not suited for this stage. The placental forceps
I
is carefully utilized with the aid of an oxytocic injection during the
operation. {3) Cervical dilatation before application of metreurynter
j
in midpregnancy {Week 14 and onward) for artificial induction of labor. 11
!
The author further reported that there is no suffering from pain and the
laminaria causes the cervix to
I
I _-
b~come soft and flexible, and enables the patient !
to be aborted without damage to the cervix. He cautioned that there were three
I
drawbacks in the usage of laminaria. The first mentioned was that if there is
failure l'o remove the laminaria, the patient wi II become infected. The second
negative aspect is that at times the laminaria is difficult to remove. The third
'
drawback peria ins spe ci fico II y to the d i Ia to ti on and suction cure ttoge procedure;
I
I
that in carrying out that procedure, there can occur injury to the cervical wall, ·
I
due to initial misplacement of the dilator and subsequent insertion of a laminaria!
into the injured tissue.
Doctor Manabe emphasized that the main reason why laminaria became
less used in Japan after World War I was because of infections caused by leaving
the laminaria in the cervix too long. He stated that:
"While the tent {s) are in the cervix it is not always necessary for the
patient to remain in the hospital. To leave them longer than 24 hours
in the cervix is not only meaningless but merely increases the chance
of infection and thus must be avoided. It is advisable to use antibiotics
prophylactically during the treatment. The same tents can be used 2 to
3 times by washing, sterilization, and storing in dehydrate alcohol.
However, ethylene oxide steri Iized disposable tents are avai Iable and
preferred in Japan in recent years. Lami nari a tents are now favored by
physicians in many countries, and this technique is an indispensable
one used in performing a great number of therapeutic abortions in Japan.
Due to the facl's presented, I would 'like to seek the appraisal of this
material by the American physicians. 11
I
l.-..... -----------------·----------------- .................... -------------·-·---------------------- ------- ............ ------------------ . . . ---------- ...... .
I
II
1
I
I
18
Summary
..
In my summation of the literature it is apparent that laminaria has not
been utilized in the United States for approximately sixty years, until the
liberalization of the abortion laws. It is apparent that very few hospitals that
perform abortions use laminaria, or are even aware of what a laminaria is.
Both the Newton(
14
)and the Eaton ( 15) studies emphasized safety, with
impressive statistical supporL Both studies touched on the mild cramping aspects
and both studies stressed that the cervix was dilated to an acceptable size for
the insertion of a cervical cannula-curette.
Doctor Manabe
(16) .
. .
dtscussed tn hts paper the success that the Japanese
have had using the laminaria in the dilatation and suct-ion curettage procedure
and in the metreurynter procedure, and he invited American physicians to test
the use of laminaria in performing abortions in the United States.
j
I
iI
I
!
L....... ···-·· ---· ·-----·· -· ---··-------------------- · · -·-·---·----·· · · · ·-----
..
19
----------------------------------------------------,--------------------·:--------------------·-----------~-----1
I
CHAPTER Ill
MATERIALS AND METHODS
Description of Population
As stated previously, the female population that was used in this study
live in the Western United States, with the majority of the patients living in
California, Arizona and Texas. Their ages range from 12 to 44. The average
age was 20. 9. The total Inglewood General Hospital saline amniocentesis population used in this study numbered 1, 114. The dates of the study were from
September 14, 1972 to May 31, 1973. The gravida range was 1 to 15, and if'
was the first pregnancy for the majority of the patients {See Table II).
The number of laminaria inserted into the patients ranged from 0 to 7 {See
Table Ill). The gestational range was from 14 to 20 weeks {See Table IV).
Plan for Statistical Analysis
Four factors were selected as possible causes on the gross time from the
time of infusion to the time of fetal expulsion. These factors were: the number
of laminaria inserted; the weeks of gestation; gravida; and the age of the
patients. All of these four factors were identifiable from the patient's medical
chart at the hospital (See Appendix). The patient's gravida was used rather than
the parity because it is believed to be more applicable to this study, because
i we are evaluating a first and second t_rimester procedure.
L~- ....... ~ --·"- ··--
i
!
II
-!
l
I
l
I
II
II
:
20
TABLE II
INGLEWOOD GENERAL HOSPITAL SALINE
AMNIOCENTESIS PATIENT•s GRAVIDAS,
SEPTEMBER 14, 1972 TO MAY 31, 1973
AND THE MEAN TIME OF INFUSION
TO EXPULSION OF THE FETUS
GRAVIDAS
NUMBER OF CASES
MEAN TIME
713
25 hrs.
2
181
22 hrs. 57 mins.
3
85
23 hrs. 29 mins.
4
54
23 hrs. 37 mins.
5
29
24 hrs. 40 mins.
6
17
28 hrs. 47 mins.
7
5
25 hrs. 12 mins.
8
8
21 hrs. 47 mins.
9 & 9+
12
28 hrs. 48 mins.
Unavai Iable
10
28 hrs. 18 mins.
1, 114
24 hrs. 38 mins.
TOTAL
__ . - -·· --·------ ----··-·· --· ·------ ···--
,
.... -·-·-·
4 mins.
------·-- ..
I!
~
'I·'
'
····-·---------~-----·---···-···--
21
TABLE Ill
NUMBER OF LAMINARIA INSERTED AT INGLEWOOD GENERAL
HOSPITAL INTO SALINE AMNIOCENTESIS PATIENTS FROM
SEPTEMBER 14, 1972 TO MAY 31, 1973 AND THE MEAN
TIME OF INFUSION TO FETUS EXPULSION
NUMBER OF LAMINARIA
0
j
I
I
NUMBER OF CASES
MEAN TIME
. 32 hrs. 7 mins.
783
24 hrs. 23 mins.
I
II
2
32
25 hrs.
3
29
25 hrs. 53 mins.
lI
4
94
21 hrs. 50 mi ns.
5
74
20 hrs. 44 mins.
I!
I
6
4
21 hrs. 42 mins.
7
1
22 hrs. 50 mins.
11114
24 hrs. 38 mins.
I
II
I
1 min.
I
II
!
I
I
I
I
TOTAL
I
97
I
..
22
TABLE IV
I.
•.
WEEKS GESTATION OF INGLEWOOD GENERAL
HOSPITAL SALINE AMNIOCENTESIS PATIENTS
FROM SEPTEMBER 14, 1972 TO MAY 31,1973
AND THE MEAN TIME OF INFUSION TO
THE EXPULSION OF THE FETUS
1
WEEKS GESTATION
NUMBER OF CASES
MEAN TIME
14 - 15
257
24 hrs. 28 mins.
16- 17
486
24 hrs. 51 mins.
18- 20
364
24 hrs. 25 mins.
Unknown
TOTAL
I
!.__ ________ _
7
11 114
24 hrs. 38 mins.
•"
23
TABLE V
AGE OF THE SALINE AMNIOCENTESIS PATIENTS
AT INGLEWOOD GENERAL HOSPITAL FROM
SEPTEMBER 14, 1972 TO MAY 31, 1973
AND THE MEAN TIME OF JNFUSION
TO THE EXPULSION OF THE FETUS
AGE
NUMBER OF CASES
I·
MEAN TIME
12- 14
29
21 hrs • 54 mins •
15- 18
432
24 hrs. 54 mins.
19- 22
340
21 hrs.
23- 26
168
25 hrs. 27 mins.
27-30
59
25 hrs. 51 mins.
31 - 34
47
24 hrs. 38 mins.
35- 38
22
25 hrs. 38 mins.
39-44
16
23 hrs.
1 min.
'
I
I
I TOTAL
I
.I
I
11 114
3 mins.
24 hrs. 38 mins.
24
-----.-·----.
·---------·-----~----·--------··-----···-·---------------····-------··--,
The patient's medical chart at Inglewood General Hospital contains the .
actual time of infusion of the saline solution, and the actual l"ime that the fetus
was expelled. The hospital's statistician computed the total hours and minutes
and noted them on the patient's chart. In designing my plan for statistical anal- i
ysis, I computed the total hours and minutes in each category for each factor.
I totalled out to the 1,114 patients in all factors. Duplicate tapes were run to
I
verify the figures. The results of the computations were summarized for each of
·I
the four factors {See Tables II through V).
I
Using the averages as shown on the tables {See Tables II and V) a regression analysis was done on the gravidas and age. The detai I on the number
of laminaria factor was punched onto 1,114 cards and both a regression analysis
I
I·
I
I
;
to show the trend, and an "F" test to show if there was a significant effect, were
performed. No statistical method was employed on the weeks gestation, because
of the consistency of the mean time applicable to the three categories, and that
the categorical number being three, made a regression analysis unnecessary {See ,
I
Table IV).
I
Additional Procedures
Aside from the methods of research described above 1 the foil owing procedures were employed by the investigator: physicians were interviewed; all
phases of the saline amniocentesis procedure were observed and available literature was researched.
In addition 1 extensive discussions with technicians and
registered nurses who have worked with the saline amniocentesis patients at
25
Inglewood General Hospital were held.
26
CHAPTER IV
RESULTS
Analysis of Data
In reviewing the results of the 11 F 11 test there is a statistically significant
association between the insertion of laminaria and the reduction of patient·time
from the infusion of the saline to the fetal expulsion. The null hypothesis is
rejected at the 99.9% confidence level. (P
Stated statistically, H0
:
M1
hypothesis was accepted, H1 ·: M1
<:001)
= M2 was rejected, thus the alternative
<
M
2
(See Table VI, for test data).
In reviewing the use of one or more Iami narias there is statistically a
significant trend with the insertion of each additional laminaria, (P
Stated statistically, H0
H1
:
true slope
<
.001).
= 0 was rejected proving
true slope =I= 0 (See Table VII for test data).
The formula for the regression is: Hours
= 25.9- 0.96 (number of
laminaria). The trend shows a reduction of .96241 (regression coefficient)
hours with the insertion of each additional laminaria.
In evaluating the age and gravidas factors no significant trend was found
at the 95% confidence level. As mentioned before, a week of gestation regression analysis was unnecessary, because the mean time did not differ
appreciably (See Table IV).
27
---·---.
----------·---·---------~----------------------------------··----l
Statistics Presentation
.
The statistical summary taken from the computer print-out for the
11
F11
test resulting in the rejection of the null hypothesis, and proving that the use
of one or more laminarias is significant in the reduction of patient time is presented in Table VI.
The statistical summary taken from the computer print-out for the
regression to ascertain if there is a significant patient time trend with the
.
number of laminarias being used is presented in Table VII.
The statistical summary taken from the computer print-out for the
regression to ascertain if there is a significant patient time trend relative to
the patient•s age is presented in Table VIII.
The statistical summary taken from the computer print-out for the
regression to ascertain if there is a significant patient time trend relative to
the patient•s gravida is presented in Table IX.
I
I
I
L _______ -·····----·-·-· .. ---------- ........ ----·---·--·--·
I
28
"-
TABLE VI
STATISTICAL SUMMARY ON "f'l TEST ON THE
USE OF LAM INARIA RELATED TO TIME REDUCTION FROM TIME OF INFUSION TO
EXPULSION OF FETUS ON SALINE
AMNIOCENTESIS PATIENTS
SUM OF
SQUARES
BETWEEN
DEGREES OF
FREEDOM
795.3750
WITHIN
89313.9375
1112
TOTAL
90109.3125
1113
MEAN
SQUARE
RATIO
795.3750
9.9028
80.3183
l
~·-~~-----~
!
I
TABLE VII
I
Il
ANALYSIS OF VARIANCE FOR THE MULTIPLE LINEAR REGRESSION
ON THE USE OF LAMINARIA RELATED TO TIME REDUCTION
FROM TIME OF INFUSION TO TIME OF EXPULSION OF
FETUS IN THE SALINE AMNIOCENTESIS PATIENT
I
I
I
j
I
I
I
I
I
Degrees of
Freedom
Sum of
Squares
Mean
Squares
"F"
I
i
Value
(
i
1
1
2346.43433
2346.43433
De vi ati on about Regression
1112
87814.12500
78.96953
Total
1113
90160.56250
Standard
Deviation
Regression
Coefficient
Std. Error
Regression
Coefficient
Computed
T Value
Partial
Correlation
Coefficient
Sum of
Square
Added
Prop.
Variables
Cumulative
-0.96241
0.17656
-5.45098
-0.16132
2346.43530
0.02603
Due to Regression
Variable
Number
Mean
1.32226 1.50868
24.62488 9. 00038
...
29.7132
____________
"'
'()
TABLE VIII
ANALYSIS OF VARIANCE FOR MULTIPLE LINEAR REGRESSION
ON AGE RELATED TO TIME REDUCTION FROM TIME OF
INFUSION TO TIME OF EXPULSION OF FETUS IN
THE SALINE AMNIOCENTESIS PATIENT
Degrees of
Freedom
Sum of
Squares
Mean
Squares·
IIFII
Value
0.9210
Due to Regression
1
3.13919
3.13919
De vi ati on about Regression
6
20.45065
3.340844
Total
7
23.58984
Variable
Number
Mean
Standard
Deviation
4.50000 2.44949
24.05426 1. 83575
Regression
Coefficient
Std. Error
Regression
Coefficient
Computed
T Value
Partial
Correlation
Coefficient
Sum of
Square
Added
Prop.
Variables
Cumulative
0.27339
0.28487
0.95969
0.36479
3.13919
0.13307
..
w
0
,
r-·-·-·-·-----.-.-·---·----,--·--·~-~
________________
I
TABLE IX
I
I
ANALYSIS OF VARIANCE FOR MULTIPLE LINEAR REGRESSION
IN RELATION TO PATIENT GRAVIDA RELATED TO TIME
REDUCTION FROM TIME OF INFUSION TO TIME OF
EXPULSION OF THE FETUS IN THE SALINE
AMNIOCENTESIS PATIENT
lI
I
I
l
I
I
Degrees of
Freedom
Sum of
Squares
Mean
Squares
IIFII
Value
1. 1439
Due to Regression
1
6.68898
6.68898
Deviation about Regression
7
40.93210
5.84744
Total
8
Variable
Number
1
4
Mean
5.00000
24.92789
I!
Standard
Deviation
Regression
Coefficient
Std. Error
Regression
Coefficient
Computed
T Value
Partial
Corre Iati on
Coefficient
Sum of
Square
Added
Prop.
Variables
Cumulative
2.73861
2.43980
0.33389
0.31218
1.06954
0.37478
6.68898
0. 14046
_____
----·----------------- "'"'"'"'---------------·------""'"''
I
32
CHAPTER V
SUMMARY AND CONCLUSIONS
Summary
The need for a better way of opening the cervix was stressed. The laminaria was introduced as a method now being used in the abortion field. The
product and it•s application in the abortion procedure was described.
The saline amniocentesis procedure, as it is performed at Inglewood
General Hospital using the laminaria, was described in detail. The reduction
of patient time from using laminaria in the saline amniocentesis procedure was
stated as the subject of this study. This savings of patient labor time is beneficial to the patient and also reduces hospital costs.
The history of laminaria was reviewed. The literature review focused on
three studies done recently on the use of laminaria in the dilatation and suction
curettage abortion. The safety benefit and the operational benefit were proven
to compare favorably with procedure~ done without laminaria.
The reduction of patient labor time was shown to be a third major benefit
in using laminaria. The null hypothesis was:
11
The insertion of a laminaria, or
laminarias, into the cervix causes no difference in the amount of time between
the infusion and the expulsion of the fetus. during the saline amniocentesis
abortion procedure. 11
33
--------------------~----
1I
.
-·-----··-. ---- ·-·- - ·- - - · - · - -.
------·----·-·--·-··--------------1
A description of the study population and the plan for a statistical
i
analysis were presented, along with the methods of research used. The resull·s
rejected the nu II hypothesis at the 99. 9% confidence Ieve I, proving that the
use of one or more laminaria does reduce patient time in the saline amniocentesis procedure. A regression analysis also reflected proof that there was a
reduction of • 96 hours with the insertion of each laminaria added after. the
initial insertion. Other factors, such as age, gravidas, and weeks of gestation
were proven at the 95% confidence level, as not being significant in the
reduction of time in the saline amniocentesis procedure. The recaps of the
statistical data supporting the analysis were presented.
Conclusions
1.
The use of one laminaria in the saline amniocentesis procedure
reduces patient time materially, approximately eight hours in
the Inglewood General Hospital population. It also benefits in
reducing the trauma and difficulty of the procedure, both to the
patient and to the physician.
2.
The use of additional laminaria in the saline amniocentesis procedure saves more time; in the Inglewood General Hospital
population
3.
• 96 hours per additional laminaria used.
The reduction of patient labor time would normally reduce
I
!
hospital costs and would enable a hospital to pass along a portion'
of the savings to the patient or to a third party payer. A cost
l
L._ .......... .
34
r
·~~----·-·-·--------------------~-·----------·---··--~··--·---,------··---·-·----·-··--·
.
. . . . . ._.._, ___ . _______________ ___, .
analysis of this time savings is suggested as an area for further .
study.
I
!
35
-·--------·-----------------------~------~-------~-----·-------
..--------------------------------,
I
BIBLIOGRAPHY
i
i
I
L............................................................................................... -----· .
36
BIBLIOGRAPHY
1.
Williams, J.: Clinical Journal, 6: 273, 1895.
2.
Therapeutic Abortion Act, California Statute, Chapter 327, filed
with Secretary of State, June 15, 1967.
3.
Unpublished Data: Planned Parenthood, Los Angeles; Health Sci~nces
Computing Facility, U.C.L.A., Sponsored by NIH Special
Research Resources Grant RR-3; March 13, 1972.
4.
United States Supreme
Court Decision; Case Number 70- 40; Doe 1 et al,:
vs Bolton, Attorney General of Georgia, et al, January 22, 1973.
5.
Rovinsky, J.: Journal of Obstetrics and Gynecology 1 38: 333,
''Abortion in New York City.u
6.
Hicks, J.B.: Practitioner 1: 83 1
7.
Skeene, A.J.C.: Inaugural Meeting of the American Gynecological
Society, New York, "Concerning Cicatrices of the Cervix 1 Uteri,
and Vagina. 11 H .0. Houghton Company, 91 - 100, 1879.
I
'
Hodgson, T.: Lancet 2: 895,
'
I
::
JlO.
I
,11.
112.
! 13.
I
1971;
1869.
1906.
Taussig, F.: "Abortion: Spontaneous and Induced ... 328; St. Louis 1
C. V. Mosby Company, 1936.
Manabe, Y .: American Journal of Obstetrics and Gynecology, 103: 232,:
"Abortion in Mid Pregnancy by Extraovular Installation of Rivanol
1
11
Solution Correlated with Placental Function.
1969.
Niswander, K.: California Medicine, 119: 11 - 14, "Lami naria Tents
as an Aid in Suction Abortion." July 1973.
i
Dorland's Illustrated Medical Dictionary, 24th Edition, W .B.Saunders Co. 1
j
Taber's Cyclopedic Medical Dictionary, 11th Edition, F.A.Davis Co.
l
1
I
t
I
t>~"•• -~~L"~---~-----·-··--- -~--·-·---•-•••••·~~- ----~----••• .... ~-~- 0_. ___
·'''''••••--<
0
37
-----------14.
15.
16.
------------~-----
-------· --------------- ·-----------:·----·- ------------~-------- --------·------------~-------------,
Newton, B.W.: American Journal of Obstetrics and Gynecology,
113: 4, 11 Laminaria Tents: Relic of· the Past or Modern Medical
Device? 11 June 15, 1972.
Eaton, C.J.; Cohn, F.; Bollinger, C.C.: Journal of Obstetrics and
Gynecology, 39: 4, 11 Laminaria Tent as a Cervical Dilator
Prior to Aspiration-Type Therapeutic Abortion. 11 April 1972.
Manabe, Y.: American Journal of Obstetrics and Gynecology, 110:
743 - 745; 11 Laminaria Tent for Gradual and Safe Cervical
Dilation • 11 1971.
1
!
Ii
! ... ··
I
I
I
I
I
38
APPENDIX
..
39
I
EX~l~~~-~ t~_VE-STIGATOR•s RAY'{ DATA RECAP
AG-6"
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C:-RAv.
,
!I
PARA
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Inglewood Hospital
•z.e lEAST ttTH STREET
• INGLEWOOD, CALIP'. •0:101
(IIJ).Il'l-041'4
11'1•41415
Family Nome
Doe
FiruNeme
Middl• Name
Jane
Marie
uo
Los Angele~
1234 Blank Street
s;x
Zone
City
Addre•
IBirthplec:e
·r·;~ ~~~2
Room No.
hone
~
State
IM
Clerk Typist
Addren of Employer Phone
Employer
Soc. Sec. No.
I. D.
Occupation
Hosp. No.
8910/PP
109/1
ldl o;v jS•Pr•"•'on IRace
Cath.
Cauc.
123-4455
90000 California
IM~rxrB·r
California
r~ma
---------
123-45-6789
Dept. No. or Local
Not Applicabl e
123 StateSt., LA 444-5555
Robert Smith & Company
IName of Spouse or Responsible Party
Patient's Insurance
Address
Patient
None
IAddress
Employer of Spouse
Phone
N/A
How Long Employed
Occupation of Spouse
N/A
N/A
IHow Related
In Case of Emergency
Remarks (Pdvate Insurance)
Address
Same as patient
· C•h, Etc.
Cash
A ttandi ng Physician
IRead;;: on
John Brown, M.D.,
Family Member
Comprehensive
DeJMndent 0
Coverage
Phone
I
Mother
Mary Doe
-1 Subscrl~r 0
Cert. or Mam. No.I Effective Date
Group No.
Name of Blue Cross and/or Blue Shield Plan
rnsurance of Spouse
leer. or
123-4455
Po 1cy No.
IAdmlulon Date and Time
11-8-72
0
0
_roup~o.
-~E1
Discharge Date and
11:00 AM
11-10-72
ect va·nate
ime
8:50AM
Admlttmg D1agnos•s Ito be completed wtthm 24 houn after admtssJOn).
lntrauteri ne Pregnancy; I 6 - I 7 weeks gestation.
Final Diagnosis
Code No.
Therapeutic Abortion of 2nd Trimester Pre!)nancy.
Operations
Therapeutic Abortion by Saline Amniocentesis.
-·
Complications
None
Results:
I)(
Improved
0
Not Improved
0
Not Treated
0
Di11gnosis Only
0 Delivered
D
0
Not Delivered
Cause of D e a t h ' - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Autopsy:
0
Yes
Died
0
No
Consultation With -~J!'a!!m=e~s_,S='!mc!.!.!.i.!2th'-!..l..-'MC!.!..'!..!D::_,•.L._ _ _ _ _.:...__ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
I have examined and approved this complete medical record and to the best of my knowledge it Is
accurate and complete.
Signed ___.,CJ..,o.,;h=n...:B,;r,_,a,_w=n,..,c...:.:M=·=Dc.:•:..rw)<-------------Attendlng Physician
ADMITTING RECORD
i
IL....-.
41
-··----~--------~--··-·-----·-··--~---------··------·---··---------·--···---~------'"-··-·--·----·--·-l
Ill
PATIENT'S CLINICAL HISTORY
DATE
//. ,f'-
GYNECOLOGY HISTORY AND PHYSICAL
'7~
Age: ~()
~/M 0 Sep
I Gr T P /liAB / LNMP ~~-·t::.·
Chief Complaint: Problem Pregnancy
Present Illness: Unable to cope with current pregnancy. Patient
?
is depressed and feels that continuation of this
pregnancy wi II advers I y affec.t her mentao nea I th.
Requests therapeutic abort ion.
Pregnancy test 1
Pelvic exam:
Fami I y His tory:
- ;,_
tn:_-Jj .
Past Hi s{ory:
Surgery
«ve6S:
(no)
lffu)-
(no)
/L
r,._
/
Illnesses
/
/
Physical Exam:
·r_,.?
P--L2 :f.
1~-
/
/
Allergies
M<!d icat ions
r.
fi
-
#A/.
~-
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p
'72
R
l'i T
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General
--#
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Neck
Breast
"'""
-.r~"f'\~
Lungs
~
D.-1~
Heart
Abdomen
.,. ... ~. . :9
~
Pelvic
Impression:
Intrauterine pregna~cy of a~proY imatel vf;t:--t7lweeks
gestation with acute depressive reaction.
Recommendations:
Therapeutic abortion
by~
Saline Amniocentesis
v
HOSPITAL NO.
l
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