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

• Sponsor: Gynuity Health Projects (Other)
• Overall Status: Completed
• CT.gov ID: NCT01539408
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 45
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Incomplete Abortion	Drug: Misoprostol; Procedure: surgery Manual vacuum aspiration (MVA)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol 400 mcg of sublingual misoprostol in one dose	Drug: Misoprostol; single dose of 400 mcg misoprostol administered sublingually
Active Comparator: Manual vacuum aspiration (MVA) Standard surgical treatment (MVA)	Procedure: surgery Manual vacuum aspiration (MVA); standard surgical treatment

Outcome Measures

Primary Outcome Measures

1. Complete abortion without recourse to surgical intervention [follow up visit 7 days after initial treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adeoyo Maternity Hospital	Ibadan		Nigeria
2	University College Hospital, Ibadan	Ibadan		Nigeria

Sponsors and Collaborators

• Gynuity Health Projects

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynuity Health Projects
• ClinicalTrials.gov Identifier: NCT01539408
• Other Study ID Numbers: 2.2.3
• First Posted: Feb 27, 2012
• Last Update Posted: Feb 27, 2012
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Abortion, Incomplete; Misoprostol

Study Results

No Results Posted as of Feb 27, 2012