Pre-induction of labour Pregnancy and Childbirth
Conditions
Interventions
The study of efficiency and safety of outpatient mifepristone usage for cervical ripening will be conducted in a large tertiary center in Moscow between January 2020 and June 2021. Primiparous and mul
Sponsors
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Healthcare of the Russian Federation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age 18-45 years 2. Gestational age of 39 - 41 weeks 3. Singleton gestation 4. Cephalic presentation 5. Bishop score 6 or less 6. Indications for labor induction (of which the induction can be postponed for 24-48 h) 7. Normal CTG tracing
Exclusion criteria
Exclusion criteria: 1. Transverse lie or presentation other than cephalic 2. Ultrasonographic estimated fetal weight greater than 4500 g or other evidence of cephalopelvic disproportion 3. Placenta previa or other unexplained vaginal bleeding 4. Previous cesarean or history of uterine surgery 5. Severe preeclampsia 6. Evidence of chorioamnionitis 7. Severe form of any preexisting medical disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bishop’s score after 24 and 48 h of the mifepristone administration 2. Additional use of prostaglandin E2 and/or mechanical methods for cervical ripening 3. Additional use of oxytocin 4. Operative delivery rate 5. Interval from cervical ripening start and labour onset | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Induction to delivery interval (IDI, from first mifepristone intake to delivery) 2. Rate of adverse effects 3. Perinatal outcomes | — |
Countries
Russian Federation
Contacts
Public ContactAnna Karapetian
Outcome results
None listed