Two Different Regimens of Misoprostol in Retained Placenta

Postpartum Haemorrhage Clinical Trial

Official title:

Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704780
• Other study ID #: HawlerMU
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: February 14, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Placenta, Retained
• Postpartum Haemorrhage
• Postpartum Hemorrhage
• Retained Placenta

Intervention

Drug:
• Misoprostol
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Locations

Country	Name	City	State
Iraq	Hawler Medical university	Erbil	Kurdistan Region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol	complete delivery of placenta after injection of intraumbilical misoprostol	up to 30 minutes after intraumbilical injection
Secondary	The amount of blood loss vaginally in both groups	To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta	up to 30 minutes after injection of placenta
Secondary	The time of delivery of placenta in both groups	the time interval estimation from the injection to complete delivery of the placenta	up to 30 minutes after delivery of the placenta
Secondary	side effects of misoprostol	Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)	up to 24 hours after delivery of placenta