400mcg Sublingual Misoprostol as First Line Treatment

Incomplete Abortion Clinical Trial

Official title:

Introduction of 400mcg Sublingual Misoprostol as First Line Treatment in 11 Health Posts in Three Districts in Senegal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939457
• Other study ID #: 2.2.4
• Status: Completed
• Phase: N/A
• First received: August 7, 2013
• Last updated: September 6, 2013
• Start date: September 2011
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Local Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• uterine size less than 12 weeks lmp

• open cervical os

• current or past vaginal bleeding

• willing to provide contact information for follow-up

• over 18 or with guardian consent

Exclusion Criteria:

• suspicion of ectopic pregnancy

• intrauterine device in place

• bad general health (infection, anemia, shoc)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Incomplete
• Incomplete Abortion

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
Senegal	Guediawaye Health Center	Guediawaye

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete abortion	number of complete abortion with misoprostol treatment alone	1 year	No