Efficacy of mifepristone followed by misoprostol compared to misoprostol alone in first-trimester miscarriage treatment

Not Applicable

Completed

• Conditions: First trimester miscarriage (embryo without cardiac activity or anembryonic gestation) up to 9 weeks of gestation, diagnosed by transvaginal ultrasonographic criteria; Pregnancy and Childbirth; Spontaneous abortion

• Registration Number: ISRCTN11046192
• Lead Sponsor: Hospital da Senhora da Oliveira Guimarães

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-12
• Study Completion: 2021-12-16
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

1. Anembryonic or missed first-trimester miscarriage up to 9 weeks of gestation by transvaginal ultrasound (diagnosis criteria according to Society of Radiologists in Ultrasound Multispeciality Consensus Conference on Early First Trimester Diagnosis of Miscarriage and Exclusion of a Viable Intrauterine Pregnancy, October 2012)
2. Healthy women aged 18 years or older

Exclusion Criteria

1. Diagnosis of inevitable or incomplete miscarriage
2. Suspicious of ectopic pregnancy or trophoblastic disease
3. Intrauterine device in place
4. Allergy to prostaglandins
5. Medical conditions contraindicating the treatment with misoprostol and/or mifepristone, namely intense vaginal bleeding with severe anemia or hemodynamic instability, suspicious of systemic infection, patients with hemorrhagic disorders or on anticoagulant therapy, patients with porphyria, uncontrolled heart disease, adrenal failure or on concurrent long-term corticosteroid therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The success of medical treatment, defined as the complete evacuation of conception products by vaginal ultrasound and, thus, no need for surgical intervention. Treatment success is evaluated at the first follow-up appointment, 2 to 3 weeks after randomization (success rate at first follow-up) and at the second appointment, 3 to 5 weeks after randomization (success rate at second follow-up). The overall success rate and the rate of uterine aspiration/curettage is also reported.