A Phase 4 interventional study of Mifepristone and Misoprostol in Missed Abortion and Pregnancy, sponsored by Gynuity Health Projects. Terminated at 4 sites in 4 countries. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
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.
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.
48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
This study's planned enrollment of 416 is above the median of 110 across 41 interventional studies indexed under Abortion, Missed.
Browse Abortion, Missed studies →Gynuity Health Projects is the lead sponsor of 113 studies on the registry; 2 are open to participants now.
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Ultrasound examination demonstrating:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Misoprostol
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
Mifepristone for treatment of missed abortion
Misoprostol for treatment of missed abortion
Rate of successful evacuation of the uterus
uterine evacuation without the need for uterine aspiration or other surgery
Time frame: 1 week after treatment
Rate of successful evacuation without any additional intervention
uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
Time frame: 1 week after treatment
Excessive bleeding or a complication for which a woman received treatment
Time frame: 30 days after treatment
Induction expulsion interval after misoprostol administration
time interval between misoprostol administration and the expulsion
Time frame: one week follow-up
Acceptability of assigned method to women
Time frame: one week follow-up
This study is terminated, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mifepristone