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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01539408
First received: February 16, 2012
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Incomplete Abortion
 Drug: Misoprostol
Procedure: surgery Manual vacuum aspiration (MVA)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Resource links provided by NLM:

Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Complete abortion without recourse to surgical intervention [ Time Frame: follow up visit 7 days after initial treatment ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539408

Locations
Nigeria
University College Hospital, Ibadan
Ibadan, Nigeria
Adeoyo Maternity Hospital
Ibadan, Nigeria
Sponsors and Collaborators
Gynuity Health Projects
  More Information

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01539408     History of Changes
Other Study ID Numbers: 2.2.3
Study First Received: February 16, 2012
Last Updated: February 21, 2012
Health Authority: Nigeria: Ministry of Health

Additional relevant MeSH terms:
Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 23, 2013