Abortion Early
Conditions
Keywords
misoprostol, abortion
Brief summary
This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol
Detailed description
Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (\<5 / ≥5) and the degree of cervical dilation (≥8mm / \<8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.
Interventions
DRUGdry misoprostol
400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
DRUGwet misoprostol
400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women with abortion (less than 12 weeks of pregnancy)
Exclusion criteria
* congestive heart failure * chronic pulmonary disease * hypovolemic shock * twins * Marfan syndrome * septic abortion (fever, pus , leukocytosis \>14,000) * known allergies to misoprostol * blood dyscrasia * open cervical (≥ 1cm) * use of intrauterine device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical dilation | 3 to 4 hours after putting misoprostol into the vagina | Cervical dilation will be measure with Karman cannulas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal acidity - hydrogen ion concentration | within 2 min before putting the misoprostol into the vagina | at the moment of the introduction of misoprostol into the vagina |
Countries
Brazil
Outcome results
None listed