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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
416
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.
Ahamadu Bello University Teachinh Hospital
Zaria, Kaduna State, Nigeria
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
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