We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539408
First Posted: February 27, 2012
Last Update Posted: February 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gynuity Health Projects
  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
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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539408


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

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
First Submitted: February 16, 2012
First Posted: February 27, 2012
Last Update Posted: February 27, 2012
Last Verified: February 2012

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


To Top