NCT03006380

Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.

Detailed description

400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients. The recruited patients will be subjected to the following: * History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history. * Checking vital signs, General and abdominal examination. * laboratory investigations: complete blood count (CBC) * Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram. * All deliveries will be attended by a senior resident in the hospital. * Included patients will receive the medication according to randomization tables. * After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss. * All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord. * All patients will undergo cord clamping and cutting within 30 seconds of delivery. * All patients will undergo uterine massage for 30 seconds after placental delivery. * Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery. * CBC will be collected 6 hours after delivery.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	oxytocin	Ecbolic used to reduce blood loss

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2017-09-01
• First posted: 2016-12-30
• Last updated: 2017-03-15

Locations

1 site across 1 country: Egypt