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Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss

NCT05124314 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-11-17

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).

The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.

Conditions

  • Abortion, Missed

Interventions

DRUG

Mifepristone, Oral, 200 Mg

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

DRUG

Misoprostol Pill

Regular treatment with vaginal Misoprostol 800 mcg

Sponsors & Collaborators

  • University of Zagreb School of Medicine

    collaborator UNKNOWN

  • Clinical Hospital Merkur

    lead OTHER

Principal Investigators

  • Mate Milas, MD · Clinical Hospital Merkur

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Croatia

Study Locations

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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 NCT05124314 on ClinicalTrials.gov