Maternal Outcomes Following Manual Lysis of the Placenta.

Официальное название

Maternal Outcomes Following Manual Lysis of the Placenta After Fifteen Compared to Thirty Minutes. A Randomized Controlled Trial.

Обзор

Comparison of maternal outcomes following manual lysis of placenta 15 vs 30 minutes after delivery. A primary outcome of the drop in hemoglobin will be compared between the two groups. Secondary outcomes include blood transfusion rate, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Подробное описание

Women undergoing spontaneous vaginal delivery at term with epidural analgesia will be randomly assigned to one of two groups: (1) manual removal of the placenta 15 minutes after delivery or (2) expectant management for 30 minutes, followed by manual removal of the placenta if it has not been delivered.

Both groups will receive active management of the third stage of labor, including oxytocin administration. Participants who develop active bleeding will undergo immediate manual removal of the placenta according to standard clinical care. Manual removal will be performed under epidural analgesia, and prophylactic antibiotics will be administered.

The primary outcome will be the difference in postpartum hemoglobin reduction between the two groups. Secondary outcomes will include incidence of blood transfusion, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate.

Вмешательства

• Процедура Manual Lysis of Placenta after 15 minutes (Intervention)
  Manual Lysis of Placenta after 15 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.
• Процедура Manual Lysis of Placenta after 30 minutes (Control)
  Manual Lysis of Placenta after 30 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.

Первичные конечные точки

• Hemoglobin Drop [Срок оценки: within 24 hours after delivery]

Вторичные конечные точки (7)

• Rate of Blood Products Given [Срок оценки: 7 days]
• Blood Loss [Срок оценки: 7 days]
• Febrile morbidity [Срок оценки: within one week of delivery]
• First Nursing [Срок оценки: 7 days]
• Hospital Stay [Срок оценки: 7 days]
• Maternal Satisfaction [Срок оценки: 7 days]
• Hemoglobin Drop [Срок оценки: up to 6 weeks postpartum]

Критерии участия

Критерии включения

• Term spontaneous vaginal delivery.
• Singleton Pregnancy.
• Epidural Analgesia during delivery.
• Age between 18 and 45 years.

Критерии исключения

• Active bleeding after delivery that warrants prompt removal of placenta regardless of time from delivery.
• Vacuum Extraction.
• Intrapartum Infection.
• Intrapartum fever above 38 degrees celsius.
• Wide 3rd and 4th degree perineal tears that mandate suturing under general anaesthesia.
• Thalassemia Carriers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Израиль · 1 центр

• Haemek Medical Center — Afula

Публикации

• Deneux-Tharaux C, Macfarlane A, Winter C, Zhang WH, Alexander S, Bouvier-Colle MH; EUPHRATES Group. Policies for manual removal of placenta at vaginal delivery: variations in timing within Europe. BJOG. 2009 Jan;116(1):119-24. doi: 10.1111/j.1471-0528.2008.01996.x. PMID 19087083
• Weeks AD. The retained placenta. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):1103-17. doi: 10.1016/j.bpobgyn.2008.07.005. Epub 2008 Sep 14. PMID 18793876
• Shinar S, Schwartz A, Maslovitz S, Many A. How Long Is Safe? Setting the Cutoff for Uncomplicated Third Stage Length: A Retrospective Case-Control Study. Birth. 2016 Mar;43(1):36-41. doi: 10.1111/birt.12200. Epub 2015 Nov 10. PMID 26555024
• Tuncalp O, Souza JP, Gulmezoglu M; World Health Organization. New WHO recommendations on prevention and treatment of postpartum hemorrhage. Int J Gynaecol Obstet. 2013 Dec;123(3):254-6. doi: 10.1016/j.ijgo.2013.06.024. Epub 2013 Aug 30. PMID 24054054
• Obajimi GO, Roberts AO, Aimakhu CO, Bello FA, Olayemi O. An appraisal of retained placentae in ibadan: a five year review. Ann Ib Postgrad Med. 2009 Jun;7(1):21-5. doi: 10.4314/aipm.v7i1.64058. PMID 25161458
• Morales M, Ceysens G, Jastrow N, Viardot C, Faron G, Vial Y, Kirkpatrick C, Irion O, Boulvain M. Spontaneous delivery or manual removal of the placenta during caesarean section: a randomised controlled trial. BJOG. 2004 Sep;111(9):908-12. doi: 10.1111/j.1471-0528.2004.00228.x. PMID 15327603
• Setubal A, Clode N, Bruno-Paiva JL, Roncon I, Graca LM. Vesicouterine fistula after manual removal of placenta in a woman with previous cesarean section. Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):75-6. doi: 10.1016/s0301-2115(98)00305-4. PMID 10413231
• Akinola OI, Fabamwo AO, Oludara B, Akinola RA, Oshodi YA, Adebayo SK. Ruptured uterus and bowel injury from manual removal of placenta: a case report. Niger Postgrad Med J. 2012 Sep;19(3):181-3. PMID 23064176

Идентификаторы

NCT: NCT03626844 · HFHOSP-322-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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