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

Detailed Description:

Objectives:

Misoprostol, a prostaglandin analogue, is principally used to prevent peptic ulcer disease induced by nonsteroidal anti-inflammatory agents .It has been shown to induce second trimester abortion .However , the optimal regimen has not been determined .Studies have used doses ranging 200- 800 microgram misoprostol at interval ranging from 3-12 hours.1,2,3,4,5 In our previous study we have compared intravaginal misoprostol with extra amniotic ethacridine lactate for second trimester MTP.6 In this study we have observed that misoprostol is highly effective( success rate 95%) for second trimester MTP with minimal side effects .& intravaginal misoprostol results in significantly shorter induction abortion interval in comparison to extra amniotic ethacridine lactate .Induction abortion interval in this study for misoprostol was 15.5 hours and the dosage of misoprostol was 400 microgram vaginally every 12 hours with a maximum of 4 doses .Success rate and induction abortion interval are the major factors of clinical importance for second trimester MTP . Our aim is to establish a dosage schedule of misoprostol which will result in high success rate in mid trimester MTP with further shortening of induction abortion interval Our study hypothesis is that using 400 microgram of vaginal misoprostol at six hour interval will result in significant shortening of induction abortion interval in comparison to 400 microgram vaginal misoprostol at 12 hour interval.

Methods - A prospective randomized comparative clinical trial will be conducted over 200 women.

Women attending the hospital for mid trimester MTP i.e. 12-20 weeks of pregnancy will be taken up for the study. Gestational age will be determined from LMP & per abdominal findings. Ultrasonography will be done in selected women where clinical finding is unreliable . All women will be examined for vital parameters and routine hematological and urine examination will be done. Randomization will be done using a table of random numbers .A written consent for inclusion in the study will be taken from all patients who will be included in the study.

In one group women will receive 400 microgram vaginal misoprostol tablet at interval of 12 hours with a maximum of four doses.

In other group women will receive 400 microgram vaginal misoprostol tablet at an interval of 6 hours with a maximum of four doses.

Failure of procedure in both groups will be defined as failed expulsion of fetus at 48 hours or as the occurrence of systemic adverse signs and symptoms severe enough to preclude the use of additional drugs.

The patient's vital signs will be monitored every four hours and the occurrence of signs and symptoms, such as fever, pain, vomiting, and diarrhea will be recorded. After expulsion of the fetus and placenta, check curettage will be done in every case. Completeness of abortion will be defined as expulsion of both placenta and fetus without operative assistance. The induction abortion interval will be defined as time from administration of 1st dose of Misoprostol to abortion of fetus. Hemorrhage will be defined as an estimated blood loss exceeding 500 ml or need to blood transfusion. Fever will be defined as rise of temperature 100.4˚ F or more occurring 24 hours or more after pregnancy termination.

The following parameters will be studied (1) Induction abortion interval (2) Completeness of procedure (3) Failure of abortion (4) side effects (5) cost per procedure.

Statistical analysis will be carried out with Epi Info statistical software.

  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
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
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 April 17, 2014