Complete Uterine Evacuation After Use of Study Drugs
Conditions
Keywords
abortion, medical abortion, mifepristone, misoprostol
Brief summary
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
Interventions
DRUGMifepristone
200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
DRUGMisoprostol
200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Closed cervical os and no vaginal bleeding * Live fetus at time of presentation for service * No contraindications to medical abortion and study procedures, according to provider * Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent * Willing to follow study procedures
Exclusion criteria
* Known previous transmural uterine incision * \> 5 parity * Signs and symptoms of infection * Any contraindications to vaginal delivery, including placenta previa * Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention. | Within 1 week | Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of fetal expulsion | Within 1 week | Defined as fetal expulsion with study drug alone. |
| Induction to abortion interval | Within 1 week | Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta. |
| Women's acceptability of the assigned method. | Within 1 week | — |
| Time interval from the mifepristone dose to abortion | Within 1 week | Defined as length of time from initiation of mifepristone to complete abortion achieved. |
| Total dose of misoprostol administered | Within 1 week | — |
| Provision of additional interventions | Within 1 week | For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs |
Countries
Vietnam
Outcome results
None listed