Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure

Wolfson Medical Center (WMC)

Status and phase: Completed; Phase 4

Conditions: Abortion, Missed

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02515604

0104-15-WOMC

Details and patient eligibility

About

A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
• Age equal or greater than 18 years
• Gestational age less than 12 complete weeks.

Exclusion criteria

• Complete, incomplete, inevitable, or septic abortion.
• Hemodynamically unstable patients.
• Misoprostol sensitivity or contraindication.
• Multifetal pregnancies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Single dose group

Active Comparator group

Treatment:

Drug: Misoprostol

Repeated dose group

Active Comparator group

Treatment:

Drug: Misoprostol