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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07566455
Enrollment
60
Registered
2026-05-05
Start date
2025-08-13
Completion date
2026-02-12
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxytocin, Postpartum Bleeding, Third Stage of Labour

Keywords

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

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.

Interventions

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.

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.

Sponsors

CMH Multan Institute of Medical Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal DeliveryFrom delivery of the baby until 24 hours postpartumThe 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).

Countries

Pakistan

Contacts

STUDY_CHAIRNidda Y Assistant Professor, FCPS

CMH Multan Institute of Medical Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026