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COURSE MANUAL Postpartum Hemorrhage Management with Uterine Balloon Tamponade Massachusetts General Hospital In partnership with KMET, JHPIEGO, Unicef, PATH, University of Nairobi, the Ministry of Health of Kenya, the Ministry of Health of the Republic of South Sudan, AIIT, and Kenya WHO © Copyright 2013 Massachusetts General Hospital, the Ministry of Health of Kenya and the Ministry of Health of the Republic of South Sudan POSTPARTUM HEMORRHAGE SALINE OXYTOCIN © Copyright 2013 Massachusetts General Hospital, the Ministry of Health of Kenya and the Ministry of Health of the Republic of South Sudan Contents 4 Background on PPH Learning Objectives 5 Definitions Causes of Postpartum Hemorrhange 6 Uterine Atony 7 Active management of third stage of labor (AMTSL) Prophylactic use of a uterotonic medication 8 Controlled cord traction for placental delivery 9 Uterine massage 10 Simple Interventions to Treat Postpartum Bleeding Breastfeeding Checking for tears 11 Empty the urinary bladder Fluid resuscitation 12 Removal of retained placenta or blood clots 13 Bimanual compression 14 Uterotonics for PPH treatment 15 Uterine Balloon Placement 16 Balloon Removal 17 Transport Planning 18 Anti-Shock Garment 19 Uterine inversion 20 Surgical treatments Uterine Compression Sutures 21 Uterine Artery Ligation Procedures Hysterectomy 22 Conclusion Background on PPH Postpartum hemorrhage (PPH) is the most common cause of maternal death around the world. In 2008, an estimated 358,000 women died from pregnancy- or childbirth-related causes.1 Twenty-five percent of these deaths were caused by postpartum hemorrhage. The highest burden of maternal mortality is in sub-Saharan Africa, where 34% of maternal deaths are caused by hemorrhage.2 This training will review the management of PPH and help participants master use of a uterine balloon for tamponade. Uterine Balloon Tamponade (UBT) is a medical technique used to control postpartum hemorrhage uncontrolled by primary interventions. UBT uses a balloon to apply pressure to the inside of the mother’s uterus to stop bleeding after delivery. UBT can be performed with devices ranging from expensive, high-grade manufactured balloons to simple balloons made of condoms or rubber gloves. We will discuss the use of the condom balloon for UBT. Learning Objectives • To be able to recognize and diagnose PPH, the most common cause of maternal death • To be able to perform a series of maneuvers to treat PPH • To be able to utilize a uterine balloon for tamponade of PPH • To be able to stabilize a woman with intractable PPH before transfer or surgery Master the following skills: • Active management of the third stage of labor • Correct dosing of uterotonics • Placement of the uterine balloon To guide us through the steps in the management of PPH, this course utilizes the checklist or algorithm shown on the inside cover of this booklet. This checklist should be displayed as a poster in all labor wards. It should be clearly visible so that providers can see it whenever a mother has PPH. For additional copies of the checklist, please contact the uterine balloon tamponade trainer. 4 Definitions • Postpartum hemorrhage is loss of blood as a result of birth which exceeds 500ml for a vaginal birth and 1000ml for a cesarean section. • Primary postpartum hemorrhage occurs within the first 24 hours after delivery. • Secondary postpartum hemorrhage occurs after 24 hours from delivery and within the first 6 weeks. Causes of Postpartum Hemorrhage There are several causes of postpartum hemorrhage which can be remembered through the classic English memory mnemonic of the “4 Ts.”3 They are: • Tone: uterine atony, distended bladder • Trauma: uterine, cervical, or vaginal injury, uterine inversion • Tissue: retained placenta or clots • Thrombin: pre-existing or acquired coagulopathy Each of these causes should be considered in any patient with PPH. They are addressed, at least in part, by the steps in the Postpartum Hemorrhage Checklist using an efficient, evidence-based approach. The most common cause of primary PPH is uterine atony. Atony is the failure of the uterine muscle to contract sufficiently after delivery, resulting in continuing blood flow from the placental bed. Secondary PPH is most commonly due to infection, retained products of conception, or both. W HO, UNICEF, UNFPA, World Bank. Trends in Maternal Mortality 1990-2008, K han et al. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-74. 3 F IGO Safe Motherhood and Newborn Health Committee. Prevention and treatment of postpartum hemorrhage in low-resource settings. International J Gyn Obstetrics. 2012;117:108–18 1 2 5 Uterine Atony The blood vessels that feed the endometrium and the placenta during pregnancy pass between muscle fibers of the uterus. Normally after delivery of the baby and placenta, the uterine muscles contract tightly, and in so doing, constrict around these blood vessels and prevent the rapid flow of blood from these vessels. If the muscle fibers fail to contract, blood continues to flow through the vessels, resulting in hemorrhage. Approximately 70-80% of primary PPH cases are due to uterine atony.4 The uterus will often contract in response to direct stimulation, such as uterine massage, and will usually respond well to uterotonic medications (discusssed later). Uterine atony is more common in situations where the uterine muscle has been stretched such as with multiple gestations, multiparous patients, polyhydramnios and macrosomia. It is also more common in prolonged labor, augmented labor, rapid labor, preeclampsia, operative delivery, or in the presence of chorioamnionitis.5 Ibid. 4 Combs CA, Murphy EL, Laros RK Jr. Factors associated with postpartum hemorrhage with 5 vaginal birth. Obstet Gynecol 1991; 77:69-76. (Level II-2). And Stones RW, Paterson CM, Saunders NJ. Risk factors for major obstetric haemorrhage. Eur J Obstet Gynecol Reprod Biol 1993; 48:15-8. 6 Active management of third stage of labor (AMTSL) Active management of the third stage of labor refers to steps taken immediately following the birth of the baby that decrease the risk of severe postpartum hemorrhage. This involves: 1. Prophylactic use of a uterotonic medication 2. Controlled cord traction for placental delivery 3. Uterine massage Prophylactic use of a uterotonic medication Uterotonics for PPH prophylaxis: given as a single dose within the first minute after completed delivery of the infant(s) Oxytocin 10 IU IM/IV • The first-line uterotonic recommended by the WHO and FIGO for PPH prevention in health facilities. • FIGO recommends for IV route use 5 IU slow IV push • Must be stored between 2-8°C. Can be held at 15-25°C for up to 30 days then discarded. Keep from freezing. Misoprostol 600μg orally • Useful in multiple settings. May also be used at the community level by community midwives and other health workers. • Store in aluminum blister pack at room temperature in a closed container. • Misoprostol can also be given sublingually if patient is unable to swallow pills or rectally if needed for a patient who is unresponsive. • May cause shivering and/or a fever. Occasionally, the fever after misoprostol can be high and will require cool sponge baths or paracetamol. Look also for other causes for the fever such as intrauterine infection Ergometrine or Methylergometrine 0.2mg IM • Contraindicated in women with high blood pressure, cardiac disease, preeclampsia or eclampsia because these medications can increase blood pressure. Avoid in unscreened populations. • Must be stored between 2-8°C and protected from light and freezing. 7 Controlled Cord Traction (CCT) involves encouraging the delivery of the placenta through gently pulling on the umbilical cord while supporting the uterus to prevent inversion. As long as the newborn does not need immediate resuscitation, wait at least 1-3 minutes after delivery before clamping and cutting the cord. According to the WHO and FIGO, CCT should only be performed by a skilled birth attendant as the cord can tear from the placental disk and too much traction without uterine support can result in uterine inversion. Steps for CCT (adapted from FIGO guidelines): 1. Clamp the cord close to the perineum and hold the cord and clamp in one hand. 2. Place the other hand just above the pubic bone to stabilize the uterus and apply counter-pressure during controlled cord traction 3. With a strong uterine contraction, gently pull downward on the cord to deliver the placenta while applying counter pressure on the uterus. The mother may be encouraged to gently bear down during this maneuver. 4. If the placenta does not descend during the initial attempts at traction, wait until the uterus feels well contracted again or there are signs of placental separation. Then repeat. Signs of placental separation: • Lengthening of the umbilical cord • Small gush of blood • Spontaneous elevation of the uterine fundus. 5. As the placenta delivers, hold the placenta in both hands and twist to encourage the membranes to come out. 6. Look carefully at the placenta to be sure it has no missing parts which may be retained in the uterus. 8 Uterine (fundal) massage is performed prophylactically after placental delivery if uterotonics were unavailable or if, upon palpation of the top of the uterus (fundus), good uterine tone is not appreciated. It is also the first step in the treatment of postpartum hemorrhage and/or uterine atony. Massaging the uterus helps it to contract. To massage properly, the fundus of the uterus should be found within the abdomen and massaged in a circular motion down towards the vagina. This procedure should be continued until the bleeding stops. After delivery, the fundus of a well contracted uterus should be at or near the level of the umbilicus. If the fundus is far above this, it may also be a sign of a full bladder. Sometimes the uterus will tighten with the massage and then relax a few minutes later. If this occurs, resume the massaging. If the bleeding is very heavy and the uterus feels relaxed or soft, the uterine massage can be performed with two hands - one hand on the fundus of the uterus and the other hand above the pubic bone holding the neck of the uterus. If this is unsuccessful, the second hand can be placed in the vagina (gloved), pushing on the uterus from inside while uterine massage is performed. Often uterine massage is all that is required for even heavy bleeding. 9 Simple Interventions to Treat Postpartum Bleeding Some very natural and early steps to treat postpartum bleeding or hemorrhage include breastfeeding; checking for signs of lacerations in the perineum, vagina or cervix; and/or emptying the maternal bladder. Breastfeeding Putting the baby directly to the breast helps the uterus contract. Stimulation of the nipples releases oxytocin into the maternal circulation and provides a natural uterotonic. Therefore, it is important for the baby AND the mother to start breastfeeding immediately after delivery. If the baby is not able to nurse, manual stimulation of the maternal nipples may also be helpful, particularly in the setting where uterotonic medications are limited or unavailable. Checking for tears A delivering mother can sustain tears in her cervix and vagina as well as in her perineum. It is difficult to see tears higher inside, but they can often be seen by using a speculum or by putting two fingers in the vagina and pushing down until the vaginal walls and cervix are visible. Vaginal wall tears can also be felt with an experienced hand. Any tear that is bleeding should have pressure applied to reduce blood loss and then be appropriately sutured. If a woman has a very large tear, she may need to be referred to a higher level health care facility, otherwise she may develop a fistula with life-long problems, such as leaking urine or stool. 10 Empty the urinary bladder A full bladder can prevent a postpartum uterus from being able to contract. Most women will not have a full bladder after pushing to deliver their baby. However, ensuring the urinary bladder is empty is a simple step which may prove helpful if there is urine in the bladder. Also, the uterus may be unable to contract if there are blood clots in the lower part of the uterus. These clots may come out when the mother squats and bears down to urinate. Women do not always have normal sensation for needing to urinate just after they have delivered. They may not be aware their bladder is full. It is often useful to have the woman try to urinate even if she cannot sense the need to go. Alternatively, a urinary catheter may be placed to ensure the bladder is emptied. While performing each of these steps, remember to continue doing fundal massage if the uterus is relaxed. Call for additional staff if bleeding is brisk to help with the massage and other measures. Fluid resuscitation SALINE A woman with postpartum hemorrhage can quickly become hemodynamically unstable and may develop hypotension, tachycardia, and with continued bleeding, shock and organ failure. Rehydration and resuscitation should start early. Even if IV fluids are unavailable, rehydration can begin for an alert mother with oral rehydration solution (ORS). If bleeding is brisk, 1-2 largebore IV catheters should be placed followed by early blood bank notification and isotonic crystalloid infusion (normal saline or lactated ringers). Call for help from physicians, any critical care specialists, and blood bank personnel. 11 Removal of retained placenta or blood clots PPH can also be caused by parts of the placenta or blood clots that are still inside the uterus. These can keep the uterus from contracting completely. Placenta or blood clots can be removed by hand as shown in the picture. This is the same maneuver that is used to remove a placenta that does not come out on its own after delivery and CCT. To do this procedure, the provider puts on sterile gloves and reaches inside the uterus, trying to separate the placenta from the uterine wall by sliding a hand beneath the placental disc and peeling the placenta away. Sometimes the placenta will not peel away completely in one piece and instead will come out in multiple pieces. Remove as much of the retained placenta and blood clots as possible while performing fundal massage to decrease the bleeding. Occasionally, the cervix will begin to contract with the blood clots still inside. If this is the case, only a couple of fingers will fit through the cervix into the uterus. Try to remove all the clots by inserting as many fingers as possible while pushing down on the fundus of the uterus with the other hand. 12 Bimanual compression Once the placenta and blood clots are removed, heavy bleeding may occur. Massage the uterus with both hands, one placed in the vagina and the other hand outside on the fundus of the uterus. This is called bimanual compression. A fist can also be placed in the vagina against the uterus with the other hand on the abdomen and the uterus is squeezed between both hands to provide pressure on the bleeding. This is an appropriate maneuver to decrease brisk blood flow while uterotonic medications are being administered and allowed to work or while a uterine balloon is being prepared for placement. This requires teamwork for simultaneous interventions. 13 Uterotonics for PPH treatment:6 Given as soon as possible after PPH is recognized. 6 Oxytocin IV infusion 20-40 IU/L fluid infusion at 40-60 drops per minute • The first line therapy recommended by the WHO and FIGO • The WHO recommends IV infusion over IM administration for treatment of PPH. • Can be used even when oxytocin has been used for prophylaxis. • Must be stored between 2-8°C. Can be held at 15-25°C for up to 30 days then discarded. Keep from freezing. Misoprostol 800 µg sublingual • Not to be used for treatment if 600 µg was just given for prophylaxis • NOTE: Treatment dose is higher than prophylactic dose. • Misoprostol can also be given rectally if needed for a patient who is unresponsive. • May cause shivering and/or a fever. Occasionally, the fever after misoprostol can be high and will require cool sponge baths or peracetamol. Look also for other causes for the fever such as intrauterine infection • Store in aluminum blister pack in a closed container. Does not require refrigeration. Ergometrine or Methylergometrine 0.2mg IM. Can repeat every 2-4 hours with a maximum of 5 doses (1mg) in 24 hours • Contraindicated in women with high blood pressure, cardiac disease, preeclampsia or eclampsia because these medicationsy can increase blood pressure. Avoid in unscreened populations. • Must be stored between 2-8°C and protected from light and freezing. Syntometrine (combination of oxytocin 5 IU and ergometrine 0.5mg) Give 1 ampule IM • Contraindicated in women with high blood pressure, cardiac disease, preeclampsia or eclampsia because this medication can increase blood pressure. Avoid in unscreened populations. • Must be stored between 2-8o C and protected from light and freezing Carbetocin 100µg IM or IV over 1 minute • Contraindicated in women with high blood pressure, cardiac disease, preeclampsia or eclampsia because this medication can increase blood pressure. Avoid in unscreened populations. • Must be stored between 2-8o C and protected from freezing. Should be used immediately after opening. Carboprost 0.25 mg IM every 15 minutes (maximum 2mg) • Contraindicated in women with high blood pressure, cardiac disease, preeclampsia or eclampsia because this medication can increase blood pressure. Avoid in unscreened populations. • Must be stored between 2-8o C and protected from freezing. FIGO Safe Motherhood and Newborn Health Committee. Prevention and treatment of postpartum hemorrhage in low-resource settings. International J Gyn Obstetrics. 2012;117:108–18 14 Tranexamic acid may be offered as a treatment for PPH if: • administration of oxytocin followed by second uterotonic has failed to stop the bleeding, or • it is thought that the bleeding may be partly due to trauma. Data on the use of tranexamic acid in obstetric literature is limited. Administration of antibiotics: In cases where endomyometritis is thought to be a contributing cause of PPH, including most cases of secondary PPH, broad spectrum antibiotics should be administered and continued as clinically indicated. Uterine Balloon Placement If a woman is still bleeding after these steps, a uterine balloon can be placed into her uterus and inflated with water. The balloon presses on the bleeding vessels inside the uterus allowing the bleeding to be controlled. Patients with the bleeding stopped in this way can be stabilized and if necessary, transferred with the balloon in place to an operating room or referral facility for further observation or treatment. Before placing the uterine balloon inside the uterus, assemble its various components. These components consist of a urinary catheter, a condom, cotton string ties, a large syringe, and a one-way valve. The condom needs to be rolled completely out and then tied to the end of the foley. The assembled condom-catheter device is then inserted into the bleeding uterus. Be sure that it is inserted through the cervical opening and into the uterus and that it is not just in the vagina. If the balloon is inflated in the vagina, it may not address bleeding from within the uterus. 15 Once the uterine balloon is in the uterus, it can be filled with clean water. Begin by inflating the small balloon of the catheter with 15 ml of water. The small balloon helps secure the catheter inside the uterus. To make it easier, the red line on the syringe indicates the amount of water needed to fill up the small balloon and another red mark on the catheter indicates where to put the 15 ml of water. The other opening (without red mark) is to blow up the condom with clean water. Fill the condom with water until the bleeding stops. This usually requires 300-500ml, but it can vary. When the bleeding stops, the mother is ready for careful observation or transfer to a referral facility. The uterine balloon should stay in place during transfer and for at least 6–24 hours. Always try to transfer the newborn with the mother so that breastfeeding can continue. A single prophylactic dose of antibiotics is recommended when the uterine balloon is placed. The mother should be given appropriate IV fluids or blood replacement products until she is stable and no longer is heavily bleeding. Balloon Removal While the woman is being observed, the balloon should then be deflated only partway and not removed. If significant bleeding resumes, the balloon can be reinflated. If there is no bleeding after an hour of partial deflation, the balloon can be completely deflated, removed, and discarded. 16 Transport Planning Some of the most important life-saving activities of medical facilities are careful planning for emergencies and good communication. For facilities without available operating rooms or physicians 24 hours daily, transfer to another facility will occasionally be required for critically ill patients. Every effort to plan for safe and efficient transfers from one facility to another should be made prior to an emergency so critical time is not wasted during an event. Skilled health personnel should always accompany a critically ill patient until they are received by appropriate staff at the referral center. Therefore facilities should be sure there is an available emergency transport vehicle, fuel for the vehicle, supplies to be used during transfers and enough available personnel for a transfer at any time. Emergency vehicles should not be used for other hospital business unless another vehicle remains available for an emergency. Communication regarding the patient must occur via phone before or immediately upon leaving the originating facility so the receiving facility can begin preparing for the patient’s arrival. Resuscitation should also begin at the originating facility including placement of IVs, crystalloid administration as well as blood products (if indicated) and available and appropriate antibiotics and medications. Upon arrival at the referral facility, the accompanying provider must be ready to inform the receiving facility of the patient’s medical history, events leading to the transfer and all treatments and medications administered before transfer. 17 Anti-Shock Garment If available, the anti-shock garment may be used as a temporizing measure to address severe blood loss and hypovolemia while a patient undergoes transfer to a referral facility for blood transfusion or further treatment. Research evaluating the potential benefits and harms of anti-shock garments is ongoing. 18 Uterine inversion A rare postpartum complication that can lead to severe and intractable postpartum hemorrhage is uterine inversion. This can occur at the time of delivery of the placenta. In uterine inversion, the fundus of the uterus descends down through the dilated cervix so that the uterus is effectively turned inside out. The provider will feel a fleshy mass upon examination of the vagina. Bleeding is often brisk and severe. To return the uterus to its normal anatomical position, the provider must, using sterile gloves, cup a hand up around the fundus and begin to push from inside at the base as pictured. Pushing directly on the fundus may lead to additional contraction of the uterine muscle and difficulty replacing the uterus. If the placenta is attached to the uterine fundus while the inversion takes place, it should not be removed as this also may cause heavier bleeding as well as contraction in the uterine muscle and make replacement extremely difficult. After the uterus is returned to the anatomic position, a prophylactic dose of antibiotics should be administered. Recommended regimens include: Ampicillin 2g IV plus Metronidazole 500mg IV or Cefazolin 1g IV plus Metronidazole 500mg IV. 19 Surgical treatments When all else fails, surgery may be required to treat postpartum hemorrhage and some women cannot survive postpartum hemorrhage without it. The following are the main surgical techniques used to treat postpartum hemorrhage. 1. Uterine Compression Sutures In this technique, the surgeon tries to compress the uterine muscles mechanically since the fibers themselves would not contract to constrict the bleeding vessels. The B-Lynch suture procedure places a large, long stitch through the anterior and posterior uterine muscle walls and across the uterine fundus so that the suture forms what looks like a set of suspenders. When tightened it cinches down the body of the uterus into a tight ball. This mechanical external compression of the uterine wall provides compression of the internal vessels. 20 2. Uterine Artery Ligation Procedures Ligation procedures target the known major blood vessels that bring blood flow to the uterus. Most of the blood flow in the uterus comes through the uterine artery which arises from major arteries in the pelvis and courses up along the uterus. There is also additional blood flow which may come through the ovarian arteries closer to the fundus of the uterus. These blood vessels can be identified, isolated, and tied off to diminish blood flow to the uterus. 3. Hysterectomy When these simpler surgical procedures fail, as a last resort, the uterus is removed to stop the continuing hemorrhage. Removal of the uterus, also known as a hysterectomy, prevents any future childbearing. The ovaries can be left still within the mother as they continue to release normal female hormones. 21 Conclusion: Postpartum hemorrhage remains a significant cause of maternal deaths worldwide. However, with appropriate use of available techniques -- including the use of uterine balloon tamponade and appropriate access to resuscitation and surgical facilities-- most cases of death from postpartum hemorrhage can and should be prevented. Use of the uterine balloon for postpartum hemorrhage represents a significant advance in non-surgical treatment of PPH and should be a part of the equipment and methods available for treatment of PPH when it is uncontrolled by normal maneuvers and uterotonics. The majority of this PPH review booklet is based on contents from the following: • FIGO Safe Motherhood and Newborn Health Committee. Prevention and treatment of postpartum hemorrhage in low-resource settings. International J Gyn Obstetrics. 2012;117:108–18. • WHO recommendations for the prevention and treatment of postpartum haemorrhage. 2012. • Postpartum haemorrhage. ACOG Practice Bulletin No. 76. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006; 108:1039-47. • National Guidelines for Quality Obstetrics and Perinatal Care. Republic of Kenya Ministry of Public Health and Sanitation and Ministry of Medical Services, 2012. • National Orientation Package for Targeted Postnatal Care. Republic of Kenya Ministry of Public Health and Sanitation, April 2011. 22 The contents of Postpartum Hemorrhage Management with Uterine Balloon Tamponade was written and edited by Dr. Melody Eckardt, Dr. Brett Nelson, Dr. Roy Ahn, Hannah Harp and Dr. Thomas Burke from Massachusetts General Hospital, Dr. Kuria Ndiritu, Dr. Pamela Godia, and Judith Maua from the Division of Reproductive Health of the Kenya MOH, and Dr. Monica Oguttu and Lidi Dulo from KMET. 24