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NCT Number: NCT07401160

Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Escuela, Tegucigalpa, Francisco Morazán Department, Honduras

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Umbilical Cord Drainage

Procedure

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.

Standard Active Management of Third Stage (No Cord Drainage)

Other

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.

Primary outcomes

  1. Change in Postpartum Blood Loss Volume

    Time frame: 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)

Secondary outcomes

  1. Change in Hemoglobin Levels

    Time frame: Pre-delivery and at 6-24 hours postpartum.

    Difference between pre-delivery and postpartum (6-24 hours) hemoglobin levels (g/dL).

  2. Need for Additional Therapeutic Interventions

    Time frame: First 24 hours postpartum.

    Requirement for additional uterotonics, uterine revision, blood transfusion, or surgical procedures to control hemorrhage.

  3. Incidence of Cord Management-Related Adverse Events

    Time frame: First 24 hours postpartum

    Occurrence of events such as retained placenta, hypovolemic shock.

  4. Maternal Satisfaction Score

    Time frame: At 2 hours postpartum.

    Maternal satisfaction with the intrapartum experience is measured using the validated Birth Satisfaction Scale-Revised (BSS-R). This is a 10-item self-report questionnaire with three subscales: Quality of Care, Women's Personal Attributes, and Stress Experienced During Labor. Items are scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with a higher total score indicating greater birth satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Ricardo A Gutierrez Ramirez, MD, MSc

CONTACT

[email protected]

+50497546940

Sponsors and collaborators

Lead sponsor

Universidad Nacional Autonoma de Honduras

Other

Registry information

Official study title

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

Acronym: CORD-PPH

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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