NCT00945997

Brief Summary

To compare the efficacy of two different dose regimens of misoprostol administered vaginally in combination with mifepristone in second trimester termination of (non)viable pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2000

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 1, 2000

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
Last Updated

July 24, 2009

Status Verified

July 1, 2009

Enrollment Period

3.9 years

First QC Date

July 23, 2009

Last Update Submit

July 23, 2009

Conditions

Termination of Pregnancy Second Trimester

Keywords

misoprostolmifepristonemedical abortionrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Expulsion rate and the number of incomplete abortions warranting surgical evacuation of retained products of conception.

    8 weeks

Secondary Outcomes (1)

  • time between the first administration of misoprostol to to delivery of the foetus

    48 hours

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: misoprostol

B

ACTIVE COMPARATOR
Drug: misoprostol

Interventions

misoprostolDRUG

mifepristone 200 mg followed by 200 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.

Also known as: migegyne, cytotec
A

Eligibility Criteria

Age16 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women with a gestational age between 14 to 24 weeks, confirmed by ultrasound, requesting termination of pregnancy

You may not qualify if:

  • No informed consent
  • Mifepristone allergy
  • Chronic adrenal gland failure
  • Kidney failure
  • Liver failure
  • Chronic use of corticosteroids
  • COPD not responsive to treatment
  • Cardiovascular disease
  • Glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Interventions

MisoprostolMifepristone

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

October 1, 2000

Primary Completion

September 1, 2004

Study Completion

March 1, 2005

Last Updated

July 24, 2009

Record last verified: 2009-07

Locations

NL(1)