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
Conditions
Interventions
Adult women diagnosed with first-trimester miscarriage (up to 9 weeks of gestation), who are eligible and choose medical treatment, are randomized to either treatment with oral mifepristone (200 mg) o
Sponsors
Hospital da Senhora da Oliveira Guimarães
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complications (namely severe bleeding or pelvic infection) evaluated by the physician at follow-up appointments or admission to emergency service 2. Adverse effects (nausea, vomiting, diarrhea, headache, dizziness, chills or fever) measured by questionnaire (binomial questions) to be answered after completing the initial treatment (mifepristone or placebo plus vaginal misoprostol) 3. Intensity of bleeding and pain measured by questionnaire (Likert-type scales) to be answered after completing the initial treatment (mifepristone or placebo plus vaginal misoprostol) 4. Acceptability of the treatment measured by questionnaire (classification of the treatment as “good”, “indifferent” or “bad” and if the participant would recommend it to a friend in the same clinical situation), to be answered after completing the initial treatment (mifepristone or placebo plus vaginal misoprostol) 5. Clinical characteristics that can influence treatment success (gravidity, parity, gestational age and diagnosis – embryo death or anembryonic gestation), assessed by the physician at randomization | — |
Countries
Portugal
Contacts
Public ContactBeatriz Bettencourt Silva
Outcome results
None listed