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

NCT07436286 | Completed DMC

• 2 other identifiers: OXYRCTABUTHZ/HREC/C08/2017
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postpartum Hemorrhage Third Stage of Labour

Outcome Measures

Primary Outcomes (2)

• Postpartum Blood Loss Measured by Calibrated Drape Weight Difference

  Total volume of blood lost during the third stage of labour and within the first hour postpartum, collected using a Nightingale drape placed under the parturient immediately after delivery. The drape was weighed before and after use, and the difference in weight in grams was taken as equivalent to blood loss in millilitres.

  Within 1 hour after delivery of the baby

• Duration of the Third Stage of Labour Measured by Stopwatch

  Time in minutes from delivery of the baby to complete expulsion of the placenta, measured using a stopwatch started immediately after birth of the baby and stopped at placental delivery.

  From delivery of the baby to delivery of the placenta

Study Arms (2)

Oxytocin group

ACTIVE COMPARATOR

Participants in this group received an intra-umbilical vein injection of 20 international units of oxytocin diluted in 18 ml of normal saline (total volume 20 ml) immediately after delivery of the baby and cord clamping. The injection was given slowly over 30 seconds into the umbilical vein. This was provided in addition to routine active management of the third stage of labour, which included intramuscular oxytocin (10 IU) and controlled cord traction.

Drug: Oxytocin

Normal Saline Group

PLACEBO COMPARATOR

Participants in this arm received an intra-umbilical vein injection of 20 ml of plain normal saline immediately after delivery of the baby and cord clamping. This was given in addition to routine active management of the third stage of labour, which included intramuscular oxytocin and controlled cord traction. The saline injection served as a placebo comparator to the oxytocin intervention.

Other: Normal Saline (Placebo)

Interventions

Oxytocin DRUG

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.

Oxytocin group

Normal Saline (Placebo) OTHER

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.

Normal Saline Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18 to 35 years Singleton live pregnancy Gestational age between 37 and 42 weeks Vaginal delivery Parity between 1 and 4 Haemoglobin concentration of 10 g/dl or higher before delivery No identifiable risk factors for postpartum haemorrhage Willing and able to provide written informed consent

You may not qualify if:

• Blood pressure ≥140/90 mmHg Placenta previa Placental abruption History of vaginal bleeding in the index pregnancy Previous caesarean section or any uterine scar Coagulation disorders Instrumental delivery Haemoglobin concentration below 10 g/dl Multiple gestation Fibroids coexisting with pregnancy Genital tract lacerations or bleeding episiotomy

Sponsors & Collaborators

• Dangana Zakari Adeka: lead
• West African College of Surgeons (WACS): collaborator

Study Sites (1)

Ahamadu Bello University Teachinh Hospital

Zaria, Kaduna State, Nigeria

Location

Related Publications (1)

• Dangana ZA. Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria. WACS Part II Dissertation, Faculty of Obstetrics and Gynaecology, 2016.

  BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin; Saline Solution

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The oxytocin and normal saline solutions were prepared by a trained nurse who was not involved in outcome assessment. Both solutions were identical in volume (20 ml) and were labelled only as "for intra-umbilical vein injection," ensuring that participants and the administering clinician could not distinguish between allocations. The primary investigator responsible for measuring postpartum blood loss, duration of the third stage of labour, and haemoglobin change was blinded to group assignment throughout data collection. Group allocation was disclosed to the investigator only after all outcome measures had been recorded for each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned into two parallel groups. One group received intra-umbilical vein injection of oxytocin in addition to routine active management of the third stage of labour, while the other group received a placebo injection of normal saline alongside the same standard management. Outcomes were compared between the two groups following delivery.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)