Comparison of Two Regimens of Misoprostol for Second Trimester Medical Termination of Pregnancy

This study has been completed.
Sponsor:
Information provided by:
Nilratan Sircar Medical College
ClinicalTrials.gov Identifier:
NCT00401440
First received: November 16, 2006
Last updated: March 11, 2010
Last verified: December 2008
  Purpose

The hypothesis of the study is that the induction abortion interval time will be significantly shorter in the group receiving vaginal misoprostol every six hours in comparison to the group who are receiving vaginal misoprostol every twelve hours.


Condition Intervention Phase
Induced Abortion
Drug: Misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Twq Different Regimen of Vaginal Misoprostol for Nid Trimester MTP

Resource links provided by NLM:


Further study details as provided by Nilratan Sircar Medical College:

Primary Outcome Measures:
  • induction abortion interval [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Success rate [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Side effects [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • complete expulsion of products of conception [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses
Drug: Misoprostol
400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses
Active Comparator: B
400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses
Drug: Misoprostol
400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women fulfilling indications of Medical Termination Of Pregnancy Act of India
  • 12-20 weeks of pregnancy

Exclusion Criteria:

  • Women with previous uterine surgery
  • Contraindication of misoprostol use
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401440

Locations
India
Department of Gynae & Obstetrics, Nilratan Sircar Medical College , Kolkata
Kolkata, West Bengal, India, 700014
Sponsors and Collaborators
Nilratan Sircar Medical College
Investigators
Principal Investigator: Snehamay Chaudhuri, MBBS,MD,DNB Nilratan Sircar Medical College , 138,AJC Bose Road , Kolkata,700014,West Bengal , India.
  More Information

Additional Information:
No publications provided

Responsible Party: Chairperson , I Ethical Committee & Principal, Nilratan Sircar Medical College , Kolkata
ClinicalTrials.gov Identifier: NCT00401440     History of Changes
Other Study ID Numbers: 3-Chaudhuri
Study First Received: November 16, 2006
Last Updated: March 11, 2010
Health Authority: India: Ministry of Health

Keywords provided by Nilratan Sircar Medical College:
Medical termination of pregnancy
Induction of abortion
Misoprostol
MTP in second trimester
400 microgram vaginal misoprostol

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

ClinicalTrials.gov processed this record on October 20, 2014