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Recruiting NCT07401160

Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

No phase Interventional Postpartum Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Umbilical Cord Drainage, Standard Active Management of Third Stage (No Cord Drainage).
Who it may be relevant to
Registry conditions: Postpartum Hemorrhage. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Honduras
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 placen
  • 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

Primary outcome measures

  • Change in Postpartum Blood Loss Volume [Time frame: From delivery until 24 hours postpartum.]
Secondary outcome measures (4)
  • Change in Hemoglobin Levels [Time frame: Pre-delivery and at 6-24 hours postpartum.]
  • Need for Additional Therapeutic Interventions [Time frame: First 24 hours postpartum.]
  • Incidence of Cord Management-Related Adverse Events [Time frame: First 24 hours postpartum]
  • Maternal Satisfaction Score [Time frame: At 2 hours postpartum.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Honduras · 2 centers
  • Hospital Escuela — Tegucigalpa
  • Instituto Hondureño de Seguridad Social — Tegucigalpa

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. PMID 39646951

Identifiers

NCT: NCT07401160 · PGO-UNAH-49-8-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗