Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria

Incomplete Abortion Clinical Trial

Official title:

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539408
• Other study ID #: 2.2.3
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2012
• Last updated: February 21, 2012
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nigeria: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• no contraindications to misoprostol

• uterine size was not larger than 12 weeks

• there were no signs of severe infection

• haemodynamically stable

• in general good health

• willing to provide contact information

Exclusion Criteria:

• an IUD in place

• ectopic pregnancy

• aged below 18 years and had no accompanying adult to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Incomplete
• Incomplete Abortion

Intervention

Drug:
• Misoprostol
single dose of 400 mcg misoprostol administered sublingually

Procedure:
• surgery Manual vacuum aspiration (MVA)
standard surgical treatment

Locations

Country	Name	City	State
Nigeria	Adeoyo Maternity Hospital	Ibadan
Nigeria	University College Hospital, Ibadan	Ibadan

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete abortion without recourse to surgical intervention		follow up visit 7 days after initial treatment	No