Health Trials

Umbilical Cord Drainage to Prevent Postpartum Hemorrhage

ConditionPostpartum Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversidad Nacional Autonoma de Honduras

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women aged 18-49 years.

Singleton pregnancy.

Gestational age ≥37 weeks.

active labor with cephalic presentation.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Umbilical Cord Drainage

    Procedure/Surgery

    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 intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Umbilical Cord Drainage GroupExperimental treatment 1 intervention
Group B: Standard Care (Control) GroupSham comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Nacional Autonoma de Honduras

Lead sponsor

Source ClinicalTrials.gov
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