Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Pregnancy Clinical Trial

Official title:

Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02342002
• Other study ID #: 1015
• Status: Terminated
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

Description:

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 416
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Ultrasound examination demonstrating:

1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR

2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.

• If fetus exists, fetal size less than 12 weeks+6 days

• Closed cervical os

• Eligible to consent for research according to local regulations

Exclusion Criteria:

• Active bleeding at enrollment and/or history of bleeding within the prior week

• Allergies or other contraindications to the use of mifepristone or misoprostol

• Suspected ectopic pregnancy

• History of trophoblastic disease

• Coagulation disorder and/or currently taking anticoagulants

• Any serious medical condition

Related Conditions & MeSH terms

• Abortion, Missed
• Missed Abortion
• Pregnancy

Intervention

Drug:
• Mifepristone
Mifepristone for treatment of missed abortion
• Misoprostol
Misoprostol for treatment of missed abortion

Locations

Country	Name	City	State
Argentina	Hospital Nacional Profesor Alejandro Posadas	Buenos Aires
Gabon	CHU Libreville	Libreville
Mexico	Hospital General Valle Ceylan	Tlalnepantla
Pakistan	Agha Khan University Hospital	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Argentina,  Gabon,  Mexico,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful evacuation of the uterus	uterine evacuation without the need for uterine aspiration or other surgery	1 week after treatment
Secondary	Rate of successful evacuation without any additional intervention	uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention	1 week after treatment
Secondary	Excessive bleeding or a complication for which a woman received treatment		30 days after treatment
Secondary	Induction expulsion interval after misoprostol administration	time interval between misoprostol administration and the expulsion	one week follow-up
Secondary	Acceptability of assigned method to women		one week follow-up