Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss

NCTNCT07566455Other idU1111-1339-8043

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 60 participants (actual)
Sponsor: CMH Multan Institute of Medical Sciences · Other gov
Design: Randomized · Single masking
Countries: 1 country
Pakistan
Start: 13 Aug 2025
Primary completion: 12 Feb 2026
Completion: 12 Feb 2026
First posted: 5 May 2026
Last update posted: 5 May 2026
Conditions: Postpartum Bleeding · Oxytocin · Third Stage of Labour

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 4
Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss
NCT07566455
13 Aug 2025 to 12 Feb 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth. The main question this study aims to answer is: Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin? Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups. Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered. In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery. Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.

Interventions

Oxytocin after deliveryDrug
Intraumbilical oxytocinDrug

Arms2

Active comparator
Intravenous Oxytocin
Women in this group will receive 10 IU oxytocin administered intravenously at the delivery of the anterior shoulder of the baby during the third stage of labor.
Experimental
Intraumbilical Oxytocin
Women in this group will receive 10 IU oxytocin administered through the umbilical vein after delivery of the baby during the third stage of labor.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery
Time frame · From delivery of the baby until 24 hours postpartum
Registry description
The average amount of blood lost after delivery will be measured in milliliters. Blood loss will be collected in a kidney tray immediately after delivery and quantified using a graduated cylinder. Additional blood loss during the first 24 hours postpartum will be measured using pre-weighed sanitary pads (1 gram weight increase = 1 mL blood loss).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Gestational age 36 - 42 weeks (on LMP) * In spontaneous labour Exclusion Criteria: * Chronic hypertension * Pre-eclampsia * Multiple pregnancies * Preterm or postdates pregnancy * Previous cesarean section * Diabetes (chronic and gestational) * Fetal macrosomia * History of bleeding / clotting disorder * History of anti-coagulation heparin / warfarin therapy * Non-reassuring cardiotocograph or poor progress of labour

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