Relationship Between Umbilical Cord Drainage and Postpartum Hemorrhage: A Randomized Single-Blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in Postpartum Blood Loss Volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician performing the final data analysis will also be blinded to group allocation. Data files for analysis will be coded (Group A, Group B) without identifying the intervention. This additional blinding is implemented to prevent bias during the statistical evaluation of primary and secondary outcomes. All other clinical and research staff involved in patient care, data collection, or immediate postpartum monitoring are unblinded.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Umbilical Cord Drainage Group
Procedure: Umbilical Cord Drainage. Passive drainage of blood from the cut maternal end of the umbilical cord into a calibrated collection drape after birth.
干预措施: Umbilical Cord Drainage (Procedure)
Standard Care (Control) Group
Other: Standard Active Management of Third Stage. Includes administration of uterotonics, controlled cord traction, and monitoring, but no specific cord drainage.
干预措施: Standard Active Management of Third Stage (No Cord Drainage) (Other)
结局指标
主要结局
Change in Postpartum Blood Loss Volume
时间窗: From delivery until 24 hours postpartum.
Difference between estimated blood loss volume in the first 24 hours postpartum and an immediate postpartum baseline. Measured using a calibrated drape (Brass-V Drape)
次要结局
- Change in Hemoglobin Levels(Pre-delivery and at 6-24 hours postpartum.)
- Need for Additional Therapeutic Interventions(First 24 hours postpartum.)
- Incidence of Cord Management-Related Adverse Events(First 24 hours postpartum)
- Maternal Satisfaction Score(At 2 hours postpartum.)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Research Coordinator
Universidad Nacional Autonoma de Honduras