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Intra-Umbilical Vein Oxytocin Injection as an Adjunct to Active Management of the Third Stage of Labour

NCT07436286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-02-27

No results posted yet for this study

Summary

This randomized controlled clinical trial evaluates the effect of umbilical vein injection of oxytocin given in addition to routine active management of the third stage of labour. The third stage of labour is associated with a risk of postpartum haemorrhage, a major cause of maternal morbidity and mortality, particularly in low-resource settings. Active management with intramuscular oxytocin and controlled cord traction is standard practice, but additional measures that can further reduce blood loss may improve maternal outcomes.

Eligible women undergoing vaginal delivery were randomly assigned to receive either an intra-umbilical injection of oxytocin diluted in normal saline or a placebo injection of normal saline, alongside standard active management of the third stage. The main outcomes assessed were postpartum blood loss, duration of the third stage of labour, and change in maternal haemoglobin concentration within 24 hours after delivery.

The study aims to determine whether local administration of oxytocin through the umbilical vein can enhance uterine contraction, promote placental separation, shorten the third stage of labour, and reduce postpartum blood loss compared with standard care alone.

Conditions

  • Postpartum Hemorrhage (PPH)
  • Postpartum Hemorrhage Third Stage of Labour Retained Placenta

Interventions

DRUG

Oxytocin

A single dose of 20 international units of oxytocin diluted in 18 ml of normal saline to a total volume of 20 ml was administered via intra-umbilical vein injection immediately after delivery of the baby and cord clamping. The injection was given slowly over approximately 30 seconds into the umbilical vein at a point 2-3 cm from the introitus using an 18-gauge needle. This was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction.

OTHER

Normal Saline (Placebo)

A volume of 20 ml of plain normal saline was administered via intra-umbilical vein injection immediately after delivery of the baby and cord clamping. The injection was identical in volume and route of administration to the oxytocin intervention but contained no active drug. This served as the placebo comparator. It was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction.

Sponsors & Collaborators

  • West African College of Surgeons (WACS)

    collaborator UNKNOWN

  • Dangana Zakari Adeka

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436286 on ClinicalTrials.gov