Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Misoprostol
- Conditions
- Postpartum Haemorrhage
- Sponsor
- Hawler Medical University
- Enrollment
- 509
- Locations
- 1
- Primary Endpoint
- Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia
Detailed Description
The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta
Investigators
Shahla Alalaf
Professor Shahla K.Alalaf
Hawler Medical University
Eligibility Criteria
Inclusion Criteria
- •women with a singleton pregnancy, delivered vaginally
- •28 weeks of gestation and more,
- •had a prolonged third stage of labor (more than 30 minutes) despite active management,
- •Haemodynamically stable and accept to participate in the trial
Exclusion Criteria
- •multiple pregnancies,
- •previous caesarean delivery,
- •haemodynamically instability, severe anaemia (haemoglobin concentration \<8 g/dL),
- •chorioamnionitis
- •Refused to participate in the trial
Arms & Interventions
400 Microgram Misoprostol
Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
Intervention: Misoprostol
800 Microgram Misoprostol
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
Intervention: Misoprostol
Outcomes
Primary Outcomes
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
Time Frame: up to 30 minutes after intraumbilical injection
complete delivery of placenta after injection of intraumbilical misoprostol
Secondary Outcomes
- side effects of misoprostol(up to 24 hours after delivery of placenta)
- The amount of blood loss vaginally in both groups(up to 30 minutes after injection of placenta)
- The time of delivery of placenta in both groups(up to 30 minutes after delivery of the placenta)