NCT00401440

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 12, 2010

Status Verified

December 1, 2008

Enrollment Period

1.7 years

First QC Date

November 16, 2006

Last Update Submit

March 11, 2010

Conditions

Induced Abortion

Keywords

Medical termination of pregnancyInduction of abortionMisoprostolMTP in second trimester400 microgram vaginal misoprostol

Outcome Measures

Primary Outcomes (1)

  • induction abortion interval

    48 hours

Secondary Outcomes (3)

  • Success rate

    48 hours

  • Side effects

    48 hours

  • complete expulsion of products of conception

    72 hours

Study Arms (2)

A

ACTIVE COMPARATOR

400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses

Drug: Misoprostol

B

ACTIVE COMPARATOR

400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses

Drug: Misoprostol

Interventions

MisoprostolDRUG

400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses

A

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women with previous uterine surgery
  • Contraindication of misoprostol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynae & Obstetrics, Nilratan Sircar Medical College , Kolkata

Kolkata, West Bengal, 700014, India

Location

Related Links

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Snehamay Chaudhuri, MBBS,MD,DNB

    Nilratan Sircar Medical College , 138,AJC Bose Road , Kolkata,700014,West Bengal , India.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 20, 2006

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 12, 2010

Record last verified: 2008-12

Locations

IN(1)