Legally Induced Abortion Without Mention of Complication
Conditions
Keywords
Second Trimester, Abortion, Misoprostol, Sublingual, Buccal
Brief summary
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
Detailed description
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
Interventions
DRUGMifepristone
200mg oral mifepristone to both study arms
doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone
Sponsors
La Rabta Maternity Hospital
Republican Institute of RH, Perinatology, and Ob/Gyn
Kathmandu Medical College and Teaching Hospital
Clinic No. 2 of Tashkent Medical Academy
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Meet criteria to obtain abortion * Present with closed cervical os and no vaginal bleeding * Live fetus at time of presentation for service * Have no contraindications to study procedures, according to provider * Be able to consent to procedure, either by reading consent document or by having consent document read to her * Be willing to follow study procedures
Exclusion criteria
* Known previous transmural uterine incision * Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol * Any contraindications to vaginal delivery * Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful abortion by 24 hours | 24 hours following the start of misoprostol | Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention. |
| Rate of successful abortion by 48 hours | 48hours following the start of misoprostol | Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention. |
Secondary
| Measure | Time frame |
|---|---|
| Total number of doses of misoprostol. | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
| Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment | 1 month |
| Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta). | 48 hours |
| Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
| Pain scale (1-7) as reported by women on questionnaire | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
| Percentage of patients requiring provision of additional interventions. | from first drug dose to complete expulsion as documented on study forms, up to 72 hours |
Countries
Armenia, Nepal, Tunisia, Uzbekistan
Outcome results
None listed