Umbilical Cord Drainage to Prevent Postpartum Hemorrhage (CORD-PPH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Procedure: Umbilical Cord Drainage; Other: Standard Active Management of Third Stage (No Cord Drainage)

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo A Gutierrez Ramirez, MD, MSc; Phone Number: +50497546940; Email: ricardo.gutierrez@unah.edu.hn

Study Locations

• Honduras
  • Francisco Morazán Department
    • Tegucigalpa, Francisco Morazán Department, Honduras, 11101
      • Recruiting
      • Hospital Escuela
      • Contact: Ricardo A Gutierrez Ramirez, MD, MSc.; Phone Number: 50497546940; Email: ricardo.gutierrez@unah.edu.hn
      • Contact: Alma I Zuniga Briceño, MD; Email: alma.zuniga@unah.edu.hn
      • Principal Investigator: Adriana M. Bran Ocon, MD
      • Principal Investigator: Alma I Zuniga Briceño, MD
    • Tegucigalpa, Francisco Morazán Department, Honduras, 11101
      • Recruiting
      • Instituto Hondureño de Seguridad Social
      • Contact: Benjamin Fortin Rivera, MD; Phone Number: 99706155; Email: bfortinr@yahoo.com
      • Principal Investigator: Clardy Martinez, MD
      • Principal Investigator: Benjamin Fortin Rivera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin Levels	Difference between pre-delivery and postpartum (6-24 hours) hemoglobin levels (g/dL).	Pre-delivery and at 6-24 hours postpartum.
Need for Additional Therapeutic Interventions	Requirement for additional uterotonics, uterine revision, blood transfusion, or surgical procedures to control hemorrhage.	First 24 hours postpartum.
Incidence of Cord Management-Related Adverse Events	Occurrence of events such as retained placenta, hypovolemic shock.	First 24 hours postpartum
Maternal Satisfaction Score	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.	At 2 hours postpartum.

Collaborators and Investigators

• Sponsor: Universidad Nacional Autonoma de Honduras

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Obstetric Hemorrhage; Cord Drainage; Third Stage of Labor; Labor Stage
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage
• Other Study ID Numbers: PGO-UNAH-49-8-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make individual participant data (IPD) available. The final decision will depend on the specific requirements of the target publication journal, further consultation with the local ethics committee regarding data sharing agreements, and a thorough assessment of our capacity to properly anonymize the data while preserving its scientific value for secondary analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No