An interventional study of Oxytocin and Normal Saline (Placebo) in Postpartum Hemorrhage (PPH) and Postpartum Hemorrhage Third Stage of Labour Retained Placenta, sponsored by Dangana Zakari Adeka. Completed at 1 site in Nigeria. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Dangana Zakari Adeka · Not applicable, Interventional, and Treatment
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.
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 416 is above the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →This is the only study on the registry with Dangana Zakari Adeka as lead sponsor.
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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
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
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 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.
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.
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.
Time frame: 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.
Time frame: From delivery of the baby to delivery of the placenta
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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