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NCT Number: NCT07566455

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CMH Multan Institute of Medical Sciences

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

    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).

Sponsors and collaborators

Lead sponsor

CMH Multan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Comparing the Effect of Intra-Umbilical Versus Intravenous Oxytocin During Third Stage of Labor on Mean Blood Loss

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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