Clinical Guidelines for Treating a Patient Experiencing Miscarriage Written by Marie A. Walter, MS, RN, C-EFM, CPLC and Rana Limbo, PhD, RN, CPLC, FAAN Part of the It’s Never Too Early™ Initiative Definition of a Miscarriage For the purposes of these clinical guidelines, we will follow the definition provided by The American College of Obstetricians and Gynecologists (ACOG) in the 2015 Practice Bulletin that describes miscarriage as “a non-viable, intrauterine pregnancy with either an empty gestational sac or a gestational sac containing an embryo or fetus without fetal heart activity within the first 12 6/7 weeks of gestation.” Ectopic pregnancy and complete molar pregnancy are both early pregnancy losses but will not be covered in the discussion. We will be defining miscarriage in the following terms: • Anembryonic or Blighted Ovum: fertilization occurs; gestational sac develops. Although the woman is pregnant, no embryo is seen. • Chemical Pregnancy: fertilization occurs; pregnancy ends before five or six weeks’ gestation; there is no gestational sac seen on ultrasound. • Partial Molar Pregnancy: fertilization occurs; mole contains both abnormal cells and an embryo or fetus which eventually is overtaken by the abnormal cells. Due to the presence of an embryo, this is defined as a miscarriage. • Embryonic or Fetal demise: fertilization occurs; cardiac activity, which was initially present, ceases, or a demonstrable embryo is not visible on ultrasound. Additionally, miscarriage can be understood based on when it occurs. • Spontaneous or Inevitable Miscarriage: the miscarriage happens on its own, without medical intervention. This spontaneous action can be deemed complete or incomplete. Complete miscarriage refers to total expulsion of all products of conception from the uterus, whereas incomplete means that some tissue or placenta remains. As it is imperative that the uterus be emptied to prevent sepsis, medical intervention is necessary. • Missed Miscarriage: a demise has occurred; the actual process of expelling the products of conception has not begun. • Threatened Miscarriage: bleeding or other signs of distress may be present, but are unconfirmed. About half of all threatened miscarriages will progress to a complete miscarriage. 2 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Causes of a Miscarriage A definite cause of the miscarriage may not be found. Genetic testing of products of conception can be offered as part of miscarriage evaluation to determine whether a chromosomal abnormality was present. Even if an abnormality is found, it is not necessarily likely to occur again. Most chromosomal abnormalities arise de novo rather than being inherited from a parent with a balanced translocation. Furthermore, some genetic abnormalities are not easily detected by conventional analysis because they are caused by point mutations, microdeletions, or duplications. Potential causes of miscarriage are listed below. • • • • • • • • • • • • • Aging ovum Irregular ovulation Luteal phase defects Prior miscarriage Maternal social factors; cigarette smoking, alcohol and illicit drug use Maternal caffeine use – dose related Uterine anomalies, both acquired and congenital, such as; Muellarian defects, adhesions from curettage or septum removal, and scarring from prior myomectomy, fibroid removal, or classical cesarean delivery Maternal infections such as; rubella, toxoplasmosis, HSV, cytomegalovirus, parvovirus, listeria, and Zika Endocrinopathies such as, thyroid dysfunction, and polycystic ovary syndrome (PCOS) Maternal Diabetes, especially if not well-controlled Thrombophilias such as; Factor V Leiden deficiency and methylene tetrahydrofolate reductase (MTHFR) Maternal immune disorders such as; lupus erythematosus and antiphospholipid antibody syndrome (APS) Embryonic/fetal chromosomal abnormality. Causative factor in 50% of all miscarriages 3 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. When Is a Miscarriage a Medical Crisis? Miscarriage typically does not rise to the level of a medical emergency. Bleeding, cramping, fever and chills, nausea, vomiting, or diarrhea are all common symptoms. Still, there is cause to consider the risk of hemorrhage, anemia, high fever, and other symptoms suggesting endometritis or extreme distress. Cognitively and/or emotionally women may feel that they are in the midst of an emergency; therefore, treatment that focuses on both the physical and emotional presentation ought to be addressed. The following symptoms warrant emergency care: • Bleeding enough to soak through one heavy duty menstrual pad per hour for 2 consecutive hours • Fever of 100.4 degrees F (38 degrees C) for more than 4 consecutive hours • Bad smelling discharge • Pain considered intolerable by the patient despite use of OTC medications such as Acetaminophen. • Blood clots the size of a plum Assess Before Treating The symptoms of miscarriage such as vaginal bleeding and utrerine cramping, are also common in a normal pregnancy (ACOG, 2015). Bleeding or spotting can occur at any time during a pregnancy. Still, when a women notices bleeding or experiences uterine cramping, she is likely to feel some measure of concern, even alarm. To distinguish between early pregnancy complications and early pregnancy loss, healthcare providers must conduct a thorough assessment. The approach should be person-, family-, and culture-centered (Lor, Crooks, & Tluczek, 2016). The evaluation must be inclusive of clinical assessments as well as the use of active listening, information sharing, ample time for processing any bad news, and decision-making. As noted by Limbo, Glasser, and Sundaram (2014), “being sure” is central to a woman’s ability to navigate through a miscarriage. She needs to be sure that her pregnancy has ended and be sure that she has chosen the treatment option that 4 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. is right for her. Thus, before any treatment options are contemplated, a thorough and accurate assessment to confirm the diagnosis is critical for the patient. Assessment components are listed below: • • • • • Thorough medical history Physical examination, including a pelvic exam Vital signs Transvaginal ultrasound Laboratory: Serum β-hCG evaluation(s) Blood type and Rh, Hemoglobin/ Hematocrit, White Count Treatment Options for Miscarriage There are three options for treating miscarriage: expectant management, medical management, and surgical treatment. Each of these options is considered safe and has comparable risk factors for infection and hemorrhage. In the presence of maternal hemodynamic instability and/or uncontrolled, heavy bleeding, suction dilation and curettage (D&C) remains the standard of care; however, if there is time to consider alternate therapies, it is vital that patients be included in decision making (Walter & Alvarado, 2017). Expectant management This approach allows the body to respond naturally to its own process of expelling the products of conception from the uterus. Bleeding and cramping occur as the cervical os dilates. A follow-up appointment with both serial β-hCG evaluations and ultrasound may be useful to confirm that the uterus is empty. Heavy or prolonged bleeding and/or intense or prolonged cramping may indicate that the miscarriage is incomplete and surgical treatment is necessary. The unpredictability of expectant management is what leads some women to choose another option. Medical management Misoprostol is a prostaglandin E1 analogue. It is typically administered intravaginally due to higher bioavailability. Oral or buccal administration is 5 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. acceptable but often leads to more bothersome side effects such as nausea and vomiting. The miscarriage typically begins within 2 to 6 hours of administration. Patient perception of pain and therefore need for analgesics may be higher. Zhang et al. (2005) reported that up to 71% of women had complete expulsion of POC with just one dose of Misoprostol. That rose to 84% with a second dose. A D&C was needed in up to 16%. A perceived advantage of medical management is that it is less invasive than surgery and yet expedites the miscarriage process. Surgical treatment Surgical options can be performed at a hospital or clinic utilizing manual vacuum or curettage. Surgical options are predictable and fast, they reduce bleeding, and they may lead to perceived better pain control by the woman. Of those women undergoing D&C, 90% had complete clearing of uterine contents by day 15, and 97% by day 30. A repeat D&C was needed only 3% of the time (Zhang et al., 2005). The major disadvantage of relying on surgery is its invasiveness and risks associated with anesthesia if used. Preparing the Patient All three treatment options come with the possibility that the woman will miscarry randomly prior to any intervention. That is, the woman may miscarry before administration of misoprostol, prior to the surgical procedure, or unexpectedly. Rather than leaving the patient unprepared for this possibility, providing comfort items for use at home is strongly recommended. These items can be placed in a nondescript bag with instructions on their use. Also included should be a bereavement folder with appropriate materials, the after-hours contact information and any other additional information that may be helpful should the patient begin to hemorrhage or otherwise feel the need for emergency care. The comfort items listed on the follow page are shown in Figure 1. • Potty hat to monitor blood loss and to safely capture the miscarriage, baby, or products of conception (POC) • Heavy duty menstrual pads 6 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. • Disposable under pads with fluid resistant backing to protect bed/furniture from absorbing blood and fluid • Disposable gloves • A small plastic container to place the POC in for safe keeping. • A muslin bag or other appropriate bag for the patient to transport the POC to the hospital or clinic Figure 1 Physiological Impact on Patients Miscarriage can be compared to the actual birthing process. As with labor at term, the amount and duration of pain, bleeding, cramping, nausea, and other symptoms experienced during a miscarriage will vary. Those providing care for the woman experiencing a miscarriage need to be aware that women will often experience fear, shock, uncertainty, and loss of control in the face of a miscarriage. This can be heightened by the intense physical symptoms they feel. • Consider antibiotic prophylaxis. 7 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. • Assess hemoglobin level if continued heavy bleeding or other signs of anemia. • Assess for clinical signs of endometritis: high fever, heavy bleeding, or increasing pelvic pain. Patients need to know that vaginal bleeding or spotting may continue for several weeks after a miscarriage. Breast tenderness, engorgement, or lactation can also occur. Menstrual cycles typically begin within 4 to 8 weeks. Sexual activity can resume when bleeding has stopped and the patient feels physically and emotionally ready. A return to normal levels of physical activity usually takes 3 to 4 weeks. If a woman knows that she will have a miscarriage, she rarely thinks about the possibility of hemorrhage. Excessive bleeding is not a common complication, but it is a type of traumatic birthing experience. Hemorrhage may cause fear for one’s life, a lack of understanding about how to manage the heavy bleeding, uncertainty about when to go to the emergency department or outpatient clinic, and an overwhelming fear that it might happen again when considering a next pregnancy. In the study by Limbo, Glasser, and Sundaram (2014), one woman who initially signed the research consent form ultimately opted out before the interview because she was too afraid to talk about her hemorrhage in the required data-gathering interview. Hormonal changes may lead to mood swings, shifts in sleeping and eating patterns, difficulty concentrating or focusing, and adjustments in your overall level of energy. Postpartum depression can also be experienced post-miscarriage. Postpartum Depression The DSM-V diagnosis of depression during the postpartum period refers to peripartum onset. It is important to recognize that the patient may present in a fragile emotional state. According to the Centers for Disease Control and Prevention (2017), 1 in 9 women experiences postpartum depression. While it is well understood that the postpartum period can be a challenging time for any woman, postpartum depression (PPD) also affects women who miscarry. 8 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. While multiple factors can contribute to postpartum depression, hormonal changes and sleep deprivation are thought to be two major factors. Certainly, the ending of a pregnancy itself can induce a grief reaction much like that felt after the death of a loved one, that is, shock and disbelief, pangs of grief, confusion, guilt, and somatic symptoms (Thieleman & Cacciatore, 2013). Still, postpartum depression is more than a grief reaction as it is marked by extreme emotions and an inability to care for oneself and one’s family. Counseling/psychotherapy and/or anti-depressant medication are preferred methods of treatment. Left unabated, postpartum depression can last for months or years and impact future pregnancies. It is important to alert the patient to the possibility of PPD and offer guidelines on how to recognize symptoms and seek professional help. Symptoms include the following: • Feeling numb, invisible, disconnected, or empty • Life feels meaningless or irrelevant • Dramatic changes in the ability to concentrate, eat, sleep, and/or perform routine tasks • Feeling worthless or hopeless • Having disturbing and/or intrusive thoughts • Thinking about harming yourself or others Communicating With the Patient Emotional and/or behavioral reactions by patients are commonplace. Being in pain or feeling fearful, in shock, or numb creates a less than ideal situation for important discussions. It is important to speak slowly, distinctly, and with a warm and compassionate voice. Rely on active listening to ensure that you are hearing not only the words of the patient, but the meaning and intentions of the communication. Pause frequently to verify what the patient understood you to say and to determine if they want information repeated. Ask the patient to repeat back instructions. 9 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Critical information should be provided in writing, and the materials should be reviewed with the patient so that they can easily locate needed information. The following tips can help guide your interactions and, if necessary, help in the delivery of “bad news”: • • • • • • • • • • • • • • Make eye contact and speak clearly and distinctly. Actively listen to the patient. Determine the patient’s understanding of what is occurring. Anticipate that the patient may have an emotional response to her current state. Correct any misunderstandings, myths, or misconceptions. Use language that matches that of the patient when referring to the pregnancy. Take into consideration the patient’s language abilities, culture, and level of education. Give a gentle warning before imparting bad news (e.g., I have some important news to share…). Allow for silence after delivering bad news so that the patient has time to absorb the information. Resist the urge to fill the quiet with information the patient/family will be unable to attend to. Be empathetic. Summarize the current situation, strategize options, and support the patient’s decision-making. Use empathy to reflect on the patient’s emotional state. o “You seem afraid, is that right?” Legitimize the patient’s experience through validation. o “Yes. You made the right choice to be seen because of the cramping and bleeding you are having. ” Appreciate the efforts the patient makes to communicate effectively. o “Thank you for telling me that you are concerned about the amount of blood you have already lost.” 10 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. • Support the patient’s feelings and thoughts. o “It’s okay with me that you are crying. I’m here to help you.” • Use active listening to fully comprehend and understand the patient. o “I gather that it hurts when I push on your abdomen here.” Respectful Disposition Far too often a patient who allowed the hospital to manage the disposition of remains may call asking, “Where is my baby?” Women who make the decision to leave the disposition of the remains up to the hospital can change perspectives. Months or years later they may question what occurred during the miscarriage and want to know and understand what happened to the remains. Requiring a process for respectful disposition is a key strategy in providing sensitive care for the patient experiencing a miscarriage. This heartrending situation is one of the major reasons why policies and procedures for respectful fetal disposition are necessary. Patient records should accurately and thoroughly record the miscarriage, including how fetal remains were managed. If the hospital was given responsibility, all pertinent data regarding date, method, and location of disposition needs to be logged. All remains should be tagged with the name of the patient so that identification is possible. Guidelines for Respectful Treatment of Fetal Remains • Provide the patient oral and written information regarding the facility’s policies and procedures for handling fetal remains. • Place no demands on the patient to make decisions within a prescribed timeframe; allow them time to process the experience. • If possible, provide the patient and family the opportunity to see, touch, name, and be witness to the baby. • Separate remains from medical waste, individually preserve them, and store them for final disposition by the patient or the facility. • Bury intact remains (individually bundled) in a single casket (co-casketing). 11 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. • Bury remains at a site deemed appropriate for burial by state and/or local law. • Cremate or incinerate the remains only if other options do not exist or are overly burdensome. Remains are separated from other medical waste and are sent to a facility licensed to dispose of fetal remains. • With facility disposition, consider hosting a Memorial or Remembrance Ceremony for interment of remains. • With private disposition, compassionately and caringly present the remains to the patient. Memorial Services Memorial services are seen as a way of helping a family say goodbye. These services aren’t necessarily considered a religious ritual; instead, they are considered a spiritual commemorative event that is welcoming and inclusive. While a particular organization may be affiliated with a specific sect or religion, all those in attendance may not share the same beliefs. With that in mind the service designed by a specific organization or person may avoid works with religious connotations and choose more humanistic works and images. Experience suggests that there may be one or more participants at the service who had a pregnancy loss in the past and may not have been afforded an opportunity for a formal recognition or chance to say goodbye. These individuals can also be allowed to remember their babies during the observance. Photographs of the memorial service are encouraged so that they can be shared with participants as a further extension of memory making. Photographs can also be made available to those women and their families that were unable to attend the observance. Families with surviving children may wish to include them. The officiant can say, “Children are present here today as significant family members: siblings of the baby who died. Please welcome them and think of ways in which they embody the sounds of the service today.” 12 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Music, either live or recorded, can help set a calming atmosphere and serve as a transition during the formal program. Songs performed by a vocalist and/or participants provide an opportunity for active participation in the observance. This unifies the group, solidifies bonds with the deceased, and allows them to access their emotions in a safe and ritualized manner. The therapeutic aspects of music have long been noted through the discipline of Music Therapy. As Berger (2012) stated, music encourages the bereaved to "tell and retell their story both as orators and listeners." While observances and rituals will change from healthcare institution to healthcare institution, Appendix A and Appendix B provide easily adaptable templates for a memorial service invitation and program. Suggested Clinical Implications • Not every woman experiencing a miscarriage considers it the loss of a baby. Assess before assuming. • Regardless of the point of entry for care, all patients experiencing an early pregnancy loss should receive the same standard of care. • Patients who have assigned personhood to their pregnancy are likely to view the miscarriage as loss of baby, child, or pregnancy. • Experiencing a miscarriage in the emergency department (ED) constitutes an emotional emergency and may constitute a medical emergency. • Staff members in the ED and outpatient settings need to know if the hospital offers “respectful disposition” and what the process entails, in order to inform the family. • Healthcare providers must co-create a plan of care and treatment plan with the patient and her family in order to assure a satisfactory resolution. • Patients leaving the ED or outpatient setting to miscarry at home should have clear, concise information about bleeding amounts, pain control, and when to return for care. • The use of a standard list of miscarriage comfort supplies (potty hat, pads, gloves, and more) will provide the patient who leaves the ED or outpatient 13 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. setting to miscarry at home with useful tools to help her through this unknown process. • A woman may view any part of the miscarriage experience as traumatic, especially heavy bleeding (i.e., hemorrhage). Evidence shows that traumatic events may lead to depression, anxiety, dwelling on the experience, and other post-traumatic responses. • Patients who miscarry will often exhibit a grief response and some will later develop symptoms of depression or PPD. 14 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Appendix A: Annual Burial and Memorial Service Information Card 15 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Appendix B: Annual Graveside Service for Pregnancy Losses Less Than 20 Weeks Opening Leader Each of you held hopes that you would gather with friends and family to celebrate the birth of your baby. Instead we stand with one another today joined in your sadness. For you mothers, for a brief time there was the stirring of life in your womb. Your baby grew inside you. For you fathers, your wife or partner nourished the seed of your future under her heart. So, too, in both of you grew hopes and dreams, and longing images of who this baby would be, and of your future with this child. Now there is emptiness and pain as you acknowledge that this seed of life could not mature fully into the child of your heart. In the Hebrew Scriptures the Psalmist writes: "Out of the depths I call to You, O God; You hear me fully when I call. God is with me, I have no fear. I was hard pressed, about to fall; God came to my help. God, you are my strength and my courage. I will not die, but live, and yet tell of the deeds of God. I thank you for having heard me; O God, be my deliverance" (Selections from Psalm 118). Reading Sometimes by Marcia Updyke Sometimes, memories are like rain showers, sprinkling down upon you, catching you unaware and then they are gone, leaving you warm and refreshed. Sometimes memories are like thundershowers, beating down upon you, relentless in their downpour, and then they will cease, leaving you tired and bruised. Sometimes, memories are like shadows sneaking up behind you, following you around. Then they disappear leaving you sad and confused. Sometimes, memories are like quilts, surrounding you with the warmth, luxuriously abundant. And sometimes they stay, wrapping you in contentment. A Litany of Voices 16 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. (based on Some People by Flavia Weedn) Voices of Mothers (women in unison) Some people come into our lives and leave footprints on our hearts, and we are never ever the same. Some people come into our lives and quickly go. Some stay for a while and embrace our silent dreams. They help us become aware of the delicate winds of hope, and we discover within every human spirit there are wings yearning to fly. They help our hearts to see that the only stairway to the stars is woven with dreams and we find ourselves unafraid to reach high. They celebrate the true essence of who we are and have faith in all that we may become. Voices of Fathers (men in unison) Some people awaken us to new and deeper realizations for we gain insight from the passing whisper of their wisdom. Throughout our lives we are sent precious souls, meant to share our journey, however brief or lasting, their stay reminds us why we are here; to learn, to teach, to nurture and to love. Voices of Parents (all voices in unison) Some people come into our lives, and they move our souls . . . . They help us to see that everything on earth is part of the incredibility of life. Leader The babies we honor today came into your lives and left footprints on your hearts. And you will never ever be the same. Blessing of the Children Leader The purpose of a blessing ceremony is to consciously acknowledge the entrance of a soul into our lives and to give thanks for the miracle of that life. It also honors the interconnectedness of this baby and family with the larger community and even all of creation. (To the parents) What name do you give your baby? Parent(s) 17 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Baby, we name you ___ (baby’s name), a sign of our love and your uniqueness. By this, we will remember you. Leader O Child, ___(baby’s name) we bless the memory of you and hold you in our hearts now and forever. Readings A Native American Prayer A Prayer for the Grieving I give you this one thought to keep – I am with you still – I do not sleep. I am a thousand winds that blow, I am the diamond glints on snow, I am the sun on ripened grain, I am the gentle autumn rain. When you awaken in the morning’s hush, I am the swift, uplifting rush of quiet birds in circled flight. I am the soft stars that shine at night. Do not think of me as gone – I am with you still in each new dawn. Author Unknown We Remember Them (Responsive reading) In the rising of the sun and in its going down 18 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. we will remember you. In the blowing of the wind and in the chill of winter we will remember you. In the opening of the buds and the rebirth of spring we will remember you. In the blueness of the skies and in the warmth of summer we will remember you. In the beginning of the year and when it ends we will remember you. So long as we live, our baby shall live For he/she is now part of us. We will remember you. From Gates of Prayer, Reform Judaism Prayer Book Prayer of Faith O God of Comfort, We trust that beyond absence there is a presence. That beyond the pain there can be healing. That beyond the brokenness there can be wholeness. That beyond the anger there may be peace. That beyond the hurting there may be forgiveness. That beyond the silence there may be the word. That beyond the word there may be understanding. That through understanding there is love. Author Unknown Ritual of Remembrance Leader 19 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Rosemary has long been known as the herb of remembrance. Today we invite you to scatter a portion or the entire herb packet on the gravesite as a living remembrance of the love for your child who continues to live in your hearts. You may wish to take some home to scatter in a shared place. Committal and Closing Blessing Leader We commit these babies to the earth and we release their spirits to the unbegun, unending mystery at the heart of life. May their spirits be at peace now and forever more. Amen. So rest in peace, now, our beloved babies. And go, friends, in sorrow and in hope, Trusting that healing and peace will come. Amen 20 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Appendix C: Products of Conception and Hospital Burial SOP 21 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. 22 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. 23 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. 24 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. 25 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. Appendix D: Less Than 20 Weeks (born dead) Miscarriage Checklist 26 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. 27 ©Copyright 2017 – All Rights Reserved. Gundersen Lutheran Medical Foundation, Inc. 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