Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion (MisoWet)

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 4

Conditions: Abortion Early

Treatments: Drug: wet misoprostol; Drug: dry misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02522078

15-0115

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

46 participants in 2 patient groups

Dry Misoprostol

Active Comparator group

Description:

400 µg of dry misoprostol

Treatment:

Drug: dry misoprostol

Wet misoprostol

Experimental group

Description:

400 µg of wet misoprostol

Treatment:

Drug: wet misoprostol