400mcg Sublingual Misoprostol as First Line Treatment

• Sponsor: Gynuity Health Projects (Other)
• Overall Status: Completed
• CT.gov ID: NCT01939457
• Collaborator: (none)
• Enrollment: 641
• Location: 1
• Arm: 1
• Duration (Months): 11
• Patients Per Site Per Month: 58.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Incomplete Abortion	Drug: Misoprostol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 641 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Introduction of 400mcg Sublingual Misoprostol as First Line Treatment in 11 Health Posts in Three Districts in Senegal
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: misoprostol 400 mcg misoprostol sublingually	Drug: Misoprostol

Outcome Measures

Primary Outcome Measures

1. complete abortion [1 year]

   number of complete abortion with misoprostol treatment alone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guediawaye Health Center	Guediawaye		Senegal

Sponsors and Collaborators

• Gynuity Health Projects

Investigators

• Principal Investigator: Beverly Winikoff, MD MPH, Gynuity Health Projects

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gynuity Health Projects
• ClinicalTrials.gov Identifier: NCT01939457
• Other Study ID Numbers: 2.2.4
• First Posted: Sep 11, 2013
• Last Update Posted: Sep 11, 2013
• Last Verified: Sep 1, 2013

• Additional relevant MeSH terms: Abortion, Incomplete; Misoprostol

Study Results

No Results Posted as of Sep 11, 2013