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

Abortion, Missed Clinical Trial

Official title:

Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515604
• Other study ID #: 0104-15-WOMC
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2015
• Last updated: October 31, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Missed

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete abortion (Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.)	Endometrial thickness of less than 15 mm, as assessed by trans-vaginal ultrasound.	Day 8 from first misoprostol dose	No