Trials / Recruiting
RecruitingNCT07401160
Umbilical Cord Drainage to Prevent Postpartum Hemorrhage
Relationship Between Umbilical Cord Drainage and Postpartum Hemorrhage: A Randomized Single-Blind Clinical Trial.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Universidad Nacional Autonoma de Honduras · Academic / Other
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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 placental expulsion. This is a non-invasive adjunct to active management of the third stage of labor. |
| OTHER | 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 blood loss is collected and measured in a standard graduated drape. This represents the current standard of care against which the experimental intervention is compared. |
Timeline
- Start date
- 2026-02-15
- Primary completion
- 2026-08-31
- Completion
- 2026-09-30
- First posted
- 2026-02-10
- Last updated
- 2026-02-13
Locations
2 sites across 1 country: Honduras
Source: ClinicalTrials.gov record NCT07401160. Inclusion in this directory is not an endorsement.