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RecruitingNCT07401160CORD-PPHUpdated Feb 13, 2026

Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

An interventional study of Umbilical Cord Drainage and Standard Active Management of Third Stage (No Cord Drainage) in Postpartum Hemorrhage, sponsored by Universidad Nacional Autonoma de Honduras. Recruiting at 2 sites in Honduras. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Universidad Nacional Autonoma de Honduras · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postpartum Hemorrhage

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Keywords

  • Cord Drainage
  • Third Stage of Labor
  • Obstetric Hemorrhage
  • Labor Stage
03

In context

Postpartum Hemorrhage

469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.

This study's planned enrollment of 400 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Universidad Nacional Autonoma de Honduras is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Planned or emergent cesarean section.
  • Instrumental delivery (e.g., forceps, vacuum).
  • Antepartum hemorrhage.
  • Severe anemia ( \<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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • 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

  • 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)

Interventions

  • ProcedureUmbilical 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.

  • OtherStandard 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.

06

What researchers measure

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)

    Time frame: From delivery until 24 hours postpartum.

Secondary outcomes

  1. Change in Hemoglobin Levels

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

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

  2. Need for Additional Therapeutic Interventions

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

    Time frame: First 24 hours postpartum.

  3. Incidence of Cord Management-Related Adverse Events

    Occurrence of events such as retained placenta, hypovolemic shock.

    Time frame: First 24 hours postpartum

  4. 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.

    Time frame: At 2 hours postpartum.

07

Study locations

2 of 2 sites recruiting
  • Hospital Escuela
    Tegucigalpa, Francisco Morazán Department 11101, Honduras
    Recruiting
    • Ricardo A Gutierrez Ramirez, MD, MSc. · Contactricardo.gutierrez@unah.edu.hn · 50497546940
    • Alma I Zuniga Briceño, MD · Contactalma.zuniga@unah.edu.hn
    • Adriana M. Bran Ocon, MD · Principal investigator
    • Alma I Zuniga Briceño, MD · Principal investigator
  • Instituto Hondureño de Seguridad Social
    Tegucigalpa, Francisco Morazán Department 11101, Honduras
    Recruiting
    • Benjamin Fortin Rivera, MD · Contactbfortinr@yahoo.com · 99706155
    • Clardy Martinez, MD · Principal investigator
    • Benjamin Fortin Rivera, MD · Principal investigator
08

References and documents

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. PubMed 39646951 ↗

Individual participant data

Plan to share: Undecided — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07401160
Lead sponsor
Universidad Nacional Autonoma de Honduras
Responsible party
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG (Research Coordinator, Universidad Nacional Autonoma de Honduras) — Principal investigator
First posted
Feb 10, 2026
Start date
Feb 15, 2026 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Feb 13, 2026

Study contacts

Ricardo A Gutierrez Ramirez, MD, MSc
Contact
ricardo.gutierrez@unah.edu.hn
+50497546940

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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