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Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

NCT02957305 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2021-04-30

Study results available
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Summary

Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.

Conditions

  • Miscarriage in First Trimester

Interventions

DRUG

Misoprostol 400mcg Tab

400µg of misoprostol (2 tablets)

DRUG

Misoprostol 200mcg Tab

200µg of misoprostol (1 tablet)

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Ricardo F Ricardo, MD, PhD · HCPA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-21
Primary Completion
2019-10-19
Completion
2020-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957305 on ClinicalTrials.gov