Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

NCT07401160 | Recruiting DMC

• 1 other identifier: PGO-UNAH-49-8-2026
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

Cord Drainage; Third Stage of Labor; Obstetric Hemorrhage; Labor Stage

Outcome Measures

Primary Outcomes (1)

• Change in Postpartum Blood Loss Volume

  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)

  From delivery until 24 hours postpartum.

Secondary Outcomes (4)

• 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.

Study Arms (2)

Umbilical Cord Drainage Group

EXPERIMENTAL

Procedure: Umbilical Cord Drainage. Passive drainage of blood from the cut maternal end of the umbilical cord into a calibrated collection drape after birth.

Procedure: Umbilical Cord Drainage

Standard Care (Control) Group

SHAM COMPARATOR

Other: Standard Active Management of Third Stage. Includes administration of uterotonics, controlled cord traction, and monitoring, but no specific cord drainage.

Other: Standard Active Management of Third Stage (No Cord Drainage)

Interventions

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.

Umbilical Cord Drainage Group

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.

Standard Care (Control) Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Only pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (2)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Instituto Hondureño de Seguridad Social

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ricardo A Gutierrez Ramirez, MD, MSc

CONTACT

+50497546940; ricardo.gutierrez@unah.edu.hn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: This is a parallel-group, two-arm, randomized, single-blind trial. Participants are randomly assigned 1:1 to receive either umbilical cord drainage (intervention) or standard active management without drainage (control). Randomization is performed via RedCap. Group assignment is concealed from the outcomes assessors (e.g., personnel measuring blood loss, analyzing lab results, scoring satisfaction scales) to maintain single-blinding and minimize measurement bias, while participants and care providers remain unblinded due to the nature of the procedure.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

HO (2)