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

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage (PPH); Postpartum Hemorrhage Third Stage of Labour Retained Placenta
• Intervention / Treatment: Drug: Oxytocin; Other: Normal Saline (Placebo)

Detailed Description

Postpartum haemorrhage remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low-resource settings. A large proportion of these deaths occur during the third stage of labour, the period between delivery of the baby and expulsion of the placenta. Failure of effective uterine contraction and delayed placental separation during this stage can lead to excessive blood loss and significant reduction in maternal haemoglobin levels. Although active management of the third stage of labour with uterotonic agents and controlled cord traction is widely practiced and has been shown to reduce blood loss, additional low-cost and practical interventions that can further improve outcomes are still needed.

Oxytocin is a uterotonic drug that promotes uterine contraction and facilitates placental separation. Administering oxytocin through the umbilical vein allows the drug to reach the placental bed directly, which may enhance localized uterine contraction at the site of placental attachment. This targeted approach has the potential to shorten the duration of the third stage of labour, reduce the volume of postpartum blood loss, and help preserve maternal haemoglobin. Such an intervention may be particularly valuable in environments where access to blood transfusion and advanced obstetric care is limited, and where even moderate blood loss can result in serious complications.

This study was conducted to examine whether the addition of intra-umbilical oxytocin to standard active management provides measurable clinical benefit. By comparing outcomes between women who received oxytocin through the umbilical vein and those who received a placebo alongside routine care, the study seeks to contribute evidence on the effectiveness of this simple and inexpensive technique in improving maternal outcomes during the immediate postpartum period. The findings are intended to inform clinical practice and support strategies aimed at reducing preventable maternal complications associated with childbirth.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Kaduna State
    • Zaria, Kaduna State, Nigeria
      • Ahamadu Bello University Teachinh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxytocin group; 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; 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.
Placebo Comparator: Normal Saline Group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dangana Zakari Adeka
• Collaborators: West African College of Surgeons (WACS)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum Hemorrhage Third Stage of Labour
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Pituitary Hormones, Posterior; Pituitary Hormones; Oxytocin; Saline Solution
• Other Study ID Numbers: OXYRCT; ABUTHZ/HREC/C08/2017 (Other Identifier: The ABUTH Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the dataset contains confidential patient information collected as part of routine clinical care. There is no formal data sharing agreement or repository established for this study. Access to the data is restricted to the research team in order to protect participant privacy and maintain confidentiality in accordance with institutional and ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No