Condition category
Pregnancy and Childbirth
Date applied
17/12/2019
Date assigned
21/02/2020
Last edited
25/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In recent years, labor induction has become more frequent, currently accounting for about 20% of pregnancies. Main indications are: prolonged pregnancy, premature rupture of membranes, high blood pressure (hypertension and preeclampsia), diabetes. Several methods have been described to promote both cervical maturation and labor itself.
The drug Mifepristone has been shown to increase uterine activity and cervical maturation. Firstly, it was used for medically induced abortion, then studies have emerged on possibilities of mifepristone usage for cervical ripening before labor induction at term pregnancy.

Who can participate?
Pregnant women aged 18 – 45 years, at 39 – 41 weeks gestation.

What does the study involve?
Participants will be given a dose of mifepristone and monitored closely if labor is not started after 24 hours, she will be given a second dose of the drug and monitored again.

What are the possible benefits and risks of participating?
Possibly, there will be not any difference in the maternal and perinatal outcomes between outpatient and inpatient groups, but perhaps women will prefer to be at home at the time of cervical ripening. Secondly, outpatient management is favorable by economic reasons.

Where is the study run from?
National Medical Research Center for Obstetrics, Gynecology and Perinatology (V.I.Kulakov), Russia

When is the study starting and how long is it expected to run for?
January 2020 to June 2021

Who is funding the study?
National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Healthcare of the Russian Federation

Who is the main contact?
1. Prof. Oleg Baev (scientific)
metod_obsgyn@hotmail.com
2. Anna Karapetian (public)
anne-89@mail.ru

Trial website

Contact information

Type

Scientific

Primary contact

Prof Oleg Baev

ORCID ID

http://orcid.org/0000-0001-8572-1971

Contact details

Academika Oparina St.,4
Moscow
117997
Russian Federation
+7 (916) 389 75 22
metod_obsgyn@hotmail.com

Type

Public

Additional contact

Mrs Anna Karapetian

ORCID ID

http://orcid.org/0000-0001-8555-144X

Contact details

Academika Oparina St.,4
Moscow
117997
Russian Federation
+7 (495) 438-11-66
inter_otdel@mail.ru

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

№ 4, 12/04/2018

Study information

Scientific title

A comparison of outpatient with inpatient mifepristone usage for cervical ripening: a randomized control study

Acronym

Study hypothesis

Is outpatient mifepristone usage efficient in cervical ripening for labor induction? Is outpatient usage of mifepristone for cervical ripening as safe as inpatient? Is outpatient usage of mifepristone for cervical ripening more favorable than inpatient in term of economic benefit?

Ethics approval

Approved 12/04/2018, Ethics commission of Federal State Budget Institution (National medical research center for obstetrics, gynecology and perinatology named after academician V.I. Kulakov of the Ministry of Healthcare of Russian Federation, Akademika Oparina St., 4, 117997, Moscow, Russia; +7 (495) 438 25 00, n_dolgushina@oparina4.ru), ref: n/a

Study design

Interventional single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-induction of labour

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 contractions, abdominal pain, bleeding, preterm rupture of membranes or reduced fetal movements. If she will not have any of the above mentioned symptoms, she will be asked to come after 24 hours from the first drug taking to assess fetal wellbeing and cervical reassessment. In case of 8 points and more on Bishop’s scale, women will be hospitalized to the maternity unit for further labor induction: amniotomy and, if uterine contractions are absent within 4 hours, oxytocin infusion. If the Bishop’s score is less than 8 and fetal condition is normal, the woman will receive the second tablet of mifepristone and be sent home for next 24 hours with the same recommendations. After 24 hours participant will admit to the maternity unit. Further induction plan will be determined depending on Bishop’s score, according to local induction protocol. If Bishop’s score is 7 and less – osmotic dilators and/or intracervical prostaglandin E2 gel (maximum three times with 6 hours intervals). If Bishop’s score is 8 and more – amniotomy and, if uterine contractions are absent within 4 hours, oxytocin infusion. Before and after interventions fetal condition will be checked. For inpatient women the pre-induction plan by mifepristone and further management are similar to outpatient.

Intervention type

Drug

Phase

Phase IV

Drug names

Mifepriston

Primary outcome measure

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 measures

1. Induction to delivery interval (IDI, from first mifepristone intake to delivery)
2. Rate of adverse effects
3. Perinatal outcomes

Overall trial start date

01/04/2018

Overall trial end date

14/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant 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

Recruitment start date

21/02/2020

Recruitment end date

31/08/2021

Locations

Countries of recruitment

Russian Federation

Trial participating centre

National Medical Research Center for Obstetrics, Gynecology and Perinatology (V.I.Kulakov)
Academician Oparina St.,4
Moscow
117198
Russian Federation

Sponsor information

Organisation

National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Healthcare of the Russian Federation

Sponsor details

Akademika Oparina St.
4
Moscow
117997
Russian Federation
+7 (495) 438 11 66
inter_otdel@mail.ru

Sponsor type

Hospital/treatment centre

Website

http://www.ncagip.ru/

Funders

Funder type

Hospital/treatment centre

Funder name

National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Healthcare of the Russian Federation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

14/07/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/02/2020: Internal review. 31/12/2019: Trial’s existence confirmed by Ethics commission of Federal State Budget Institution