Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

Официальное название

Relationship Between Umbilical Cord Drainage and Postpartum Hemorrhage: A Randomized Single-Blind Clinical Trial.

Обзор

This study aims to analyze whether there is a significant difference in the occurrence of postpartum hemorrhage between women who underwent umbilical cord drainage and those who did not. Variables such as estimated blood loss volume, drop in hemoglobin levels, and the need for additional maneuvers or treatments to control hemorrhage will be examined. The research will be conducted under a parallel-group clinical trial design at the Hospital Escuela Universitario. Post-birth umbilical cord drainage may contribute to a lower frequency of postpartum hemorrhage compared to not performing it.

Подробное описание

This is a single-blind, parallel-group, superiority efficacy clinical trial. The intervention involves passive drainage of blood from the umbilical cord immediately after cord clamping and cutting, allowing it to flow into a calibrated drape. The control group receives standard active management of the third stage of labor without cord drainage. The primary objective is to compare postpartum blood loss between the groups. Secondary objectives include comparing pre- and postpartum hemoglobin levels, the need for additional therapeutic interventions (uterotonics, uterine revision, transfusion), incidence of adverse events related to cord management, and maternal satisfaction using the Birth Satisfaction Scale. The study plans to enroll 400 participants (200 per group) over approximately 6 months at a single center.

Вмешательства

• Процедура Umbilical Cord Drainage
  Following delivery of the newborn and immediate clamping/cutting of the umbilical cord, the maternal end of the cord is unclamped and allowed to drain passively. The cord is held over a sterile, graduated collection drape (Brass-V Drape) to facilitate the complete, gravity-dependent emptying of the residual placental blood (approximately 50-100 mL) prior to placental delivery. The procedure is completed within 1-3 minutes, after which standard controlled cord traction is applied to assist placen
• Другое Standard Active Management of Third Stage (No Cord Drainage)
  This arm receives the standard, evidence-based active management of the third stage of labor, as per institutional protocol, without the specific addition of umbilical cord drainage. The procedure includes immediate administration of a prophylactic uterotonic agent (e.g., oxytocin), delayed cord clamping (as per routine practice), controlled cord traction with counter-pressure on the uterus (Brandt-Andrews maneuver) to assist placental delivery, and uterine massage after placental expulsion. All

Первичные конечные точки

• Change in Postpartum Blood Loss Volume [Срок оценки: From delivery until 24 hours postpartum.]

Вторичные конечные точки (4)

• Change in Hemoglobin Levels [Срок оценки: Pre-delivery and at 6-24 hours postpartum.]
• Need for Additional Therapeutic Interventions [Срок оценки: First 24 hours postpartum.]
• Incidence of Cord Management-Related Adverse Events [Срок оценки: First 24 hours postpartum]
• Maternal Satisfaction Score [Срок оценки: At 2 hours postpartum.]

Критерии участия

Критерии включения

• Pregnant women aged 18-49 years.
• Singleton pregnancy.
• Gestational age ≥37 weeks.
• active labor with cephalic presentation.
• Planned for vaginal delivery.
• Capable of providing informed consent.

Критерии исключения

• Planned or emergent cesarean section.
• Instrumental delivery (e.g., forceps, vacuum).
• Antepartum hemorrhage.
• Severe anemia (Hemoglobin <8 g/dL) or specific hematological disorders (e.g., sickle cell disease, thalassemia, hemophilia, thrombocytopenia <100,000/µL).
• Use of anticoagulant medication.
• Non-cephalic fetal presentation (e.g., breech, transverse).
• Refusal to participate or inability to provide informed consent.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

Honduras · 2 центра

• Hospital Escuela — Tegucigalpa
• Instituto Hondureño de Seguridad Social — Tegucigalpa

Публикации

• Koshkin ES. A review of the genus Dodia Dyar, 1901 (Lepidoptera: Erebidae, Arctiinae) with description of a new remarkable species from the Russian Far East. Zootaxa. 2024 May 27;5458(1):53-72. doi: 10.11646/zootaxa.5458.1.2. PMID 39646951

Идентификаторы

NCT: NCT07401160 · PGO-UNAH-49-8-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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