Missed Abortion, Pregnancy
Conditions
Keywords
mifepristone, misoprostol, obstetrics, reproductive health, pregnancy, abortion, missed abortion
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.
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.
Interventions
DRUGMifepristone
Mifepristone for treatment of missed abortion
DRUGMisoprostol
Misoprostol for treatment of missed abortion
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful evacuation of the uterus | 1 week after treatment | uterine evacuation without the need for uterine aspiration or other surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Argentina, Gabon, Mexico, Pakistan
Outcome results
None listed