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

Sponsor

Gynuity Health Projects (Other)

Overall Status

Terminated

CT.gov ID

NCT02342002

Collaborator

(none)

416

Enrollment

Locations

Arms

Duration (Months)

104

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Missed Abortion Pregnancy	Drug: Mifepristone Drug: Misoprostol	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

416 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mifepristone-misoprostol regimen After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.	Drug: Mifepristone Mifepristone for treatment of missed abortion Drug: Misoprostol Misoprostol for treatment of missed abortion
Placebo Comparator: Misoprostol alone regimen After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.	Drug: Misoprostol Misoprostol for treatment of missed abortion

Arm

Intervention/Treatment

Experimental: Mifepristone-misoprostol regimen

After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.

Drug: Mifepristone

Mifepristone for treatment of missed abortion

Drug: Misoprostol

Misoprostol for treatment of missed abortion

Placebo Comparator: Misoprostol alone regimen

After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.

Drug: Misoprostol

Misoprostol for treatment of missed abortion

Outcome Measures

Primary Outcome Measures

Rate of successful evacuation of the uterus [1 week after treatment]
uterine evacuation without the need for uterine aspiration or other surgery

Secondary Outcome Measures

Rate of successful evacuation without any additional intervention [1 week after treatment]
uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
Excessive bleeding or a complication for which a woman received treatment [30 days after treatment]
Induction expulsion interval after misoprostol administration [one week follow-up]
time interval between misoprostol administration and the expulsion
Acceptability of assigned method to women [one week follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ultrasound examination demonstrating:

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

Contacts and Locations

Locations

	Site	City	Country
1	Hospital Nacional Profesor Alejandro Posadas	Buenos Aires	Argentina
2	CHU Libreville	Libreville	Gabon
3	Hospital General Valle Ceylan	Tlalnepantla	Mexico
4	Agha Khan University Hospital	Karachi	Pakistan