Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedFebruary 27, 2012
February 1, 2012
1.2 years
February 16, 2012
February 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Complete abortion without recourse to surgical intervention
follow up visit 7 days after initial treatment
Study Arms (2)
Misoprostol
ACTIVE COMPARATOR400 mcg of sublingual misoprostol in one dose
Manual vacuum aspiration (MVA)
ACTIVE COMPARATORStandard surgical treatment (MVA)
Interventions
standard surgical treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- an IUD in place
- ectopic pregnancy
- aged below 18 years and had no accompanying adult to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Adeoyo Maternity Hospital
Ibadan, Nigeria
University College Hospital, Ibadan
Ibadan, Nigeria
Related Publications (3)
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PMID: 34061352DERIVEDShochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127.
PMID: 23150927DERIVEDFawole AO, Diop A, Adeyanju AO, Aremu OT, Winikoff B. Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria. Int J Gynaecol Obstet. 2012 Nov;119(2):170-3. doi: 10.1016/j.ijgo.2012.06.012. Epub 2012 Aug 27.
PMID: 22935620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 27, 2012
Study Start
August 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 27, 2012
Record last verified: 2012-02