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

NCT07566455 | Completed Phase 4

• 1 other identifier: U1111-1339-8043
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Bleeding; Oxytocin; Third Stage of Labour

Keywords

Intravenous oxytocin; intra umbilical oxytocin; postpartum hemorrhage; third stage of labour

Outcome Measures

Primary Outcomes (1)

• Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery

  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).

  From delivery of the baby until 24 hours postpartum

Study Arms (2)

Intravenous Oxytocin

ACTIVE COMPARATOR

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.

Drug: Oxytocin after delivery

Intraumbilical Oxytocin

EXPERIMENTAL

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.

Drug: Intraumbilical oxytocin

Interventions

Oxytocin after delivery DRUG

10 IU oxytocin diluted in normal saline administered slowly via intravenous route at the time of delivery of the anterior shoulder to facilitate uterine contraction and reduce blood loss.

Intravenous Oxytocin

Intraumbilical oxytocin DRUG

10 IU oxytocin diluted in 10 mL normal saline injected into the umbilical vein approximately 2 cm from the introitus after delivery of the baby, with the solution gently milked toward the placental insertion to promote placental separation and reduce blood loss.

Intraumbilical Oxytocin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age 36 - 42 weeks (on LMP)
• In spontaneous labour

You may not qualify if:

• 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

Sponsors & Collaborators

• CMH Multan Institute of Medical Sciences: lead

Study Sites (1)

CMH Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nidda Y Assistant Professor, FCPS

  CMH Multan Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: August 13, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)