A comparison of outpatient with inpatient mifepristone usage for cervical ripening before labor induction

INTERVENTION: 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 multiparous women with a singleton pregnancy with fetus in cephalic presentation at gestational age between 39 and 41+6 weeks, cervical Bishop’s score 6 or less and indications for labor induction (of which the induction can be postponed for 24‐48 h) will be invited to participate in the trial. Gestational age will be confirmed by the first‐trimester ultrasound. Participants will be randomly assigned to either Group Outpatient or Group Inpatient (control) based on computer‐generated random numbers. Principle of block randomization will be used to assign patients to the groups, with a block size of ten. An envelope should be opened for all consecutive participants to reveal their group assignment at the moment when they recruit into the study. Patients of Group Outpatient will discharge after mifepristone administration. A written document with all the information that should bring them back to the hospital (information for patient) will be given. Patients in Group Inpatient will receive mifepristone and stay in the inpatient setting in accordance to the Department’s protocol. Detailed methodology: Women will be considered for recruitment into the study after collection anamnesis data, pelvic examination for assessment Bishop’s score and signed informed consent. Before drug taking, fetal wellbeing will be evaluated using cardiotocography (CTG). If fetal heart normal, the drug will be given and woman will be sent home. The woman will be advised to come to the maternity unit if she has uterine con CONDITION: Pre‐induction of labour ; Pregnancy and Childbirth PRIMARY OUTCOME: ; 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 OUTCOME: ; 1. Induction to delivery interval (IDI, from first mifepristone intake to delivery); 2. Rate of adverse effects; 3. Perinatal outcomes; 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