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Comparing Two Medical Treatments for Early Pregnancy Failure.

NCT03212352 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2020-05-01

No results posted yet for this study

Summary

This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

Conditions

  • Early Pregnancy Failure

Interventions

DRUG

Mifepristone

Adding 600 mg of Mifepristone to the regular treatment with Misoprostol 800 mcg.

DRUG

Misoprostol

Regular treatment with Misoprostol 800 mcg.

Sponsors & Collaborators

  • Innovatiefonds Zorgverzekeraars

    collaborator OTHER

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Frank P. Vandenbussche, Prof. Dr. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2020-01-23
Completion
2020-03-16

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212352 on ClinicalTrials.gov