Two Different Regimens of Misoprostol in Retained Placenta

Phase 2

Completed

• Conditions: Retained Placenta; Postpartum Haemorrhage
• Interventions: Drug: Misoprostol

• Registration Number: NCT02704780
• Lead Sponsor: Hawler Medical University

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

Study Timeline

• Study First Submitted: 2016-02-19
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-10
• Status Verified: 2019-02
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-14
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 509

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
800 Microgram Misoprostol	Misoprostol	Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
400 Microgram Misoprostol	Misoprostol	Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group

Primary Outcome Measures

Name	Time	Method
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol	up to 30 minutes after intraumbilical injection	complete delivery of placenta after injection of intraumbilical misoprostol

Secondary Outcome Measures

Name	Time	Method
side effects of misoprostol	up to 24 hours after delivery of placenta	Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)
The amount of blood loss vaginally in both groups	up to 30 minutes after injection of placenta	To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta
The time of delivery of placenta in both groups	up to 30 minutes after delivery of the placenta	the time interval estimation from the injection to complete delivery of the placenta

Trial Locations

Locations (1)

Hawler Medical university; 🇮🇶 Erbil, Kurdistan Region, Iraq