RCOG 2025

[CTRI/2021/07/034943]

METHODOLOGY

All women planned for IOL from December 2021 to April

2023 at a tertiary care centre in South India, fulfilling the

eligibility criteria, were recruited. The participants were

equally randomized into two groups:

OBJECTIVE

▪ Induction of labour (IOL) at term and late-term is the most commonly performed procedure

worldwide, with an incidence of 25%. It is indicated either for maternal or foetal indications. The

success of IOL depends on the degree of ripening of the cervix.

▪ The aim of the study was to determine and compare the EFFICACY i.e., change in Bishop score and the

SAFETY of oral Mifepristone with transcervical Foley catheter in women with singleton term and late

term pregnancy undergoing pre-induction cervical ripening.

STUDY DESIGN

Open-label | Randomized Controlled | Non-inferiority Trail

Group B (n=133)

Transcervical Foley for

24 hours.

Group A (n=133)

Single Oral Mifepristone

400mg

Mifepristone Versus Transcervical Foley Catheter for Pre-induction Cervical Ripening – Randomised Controlled Trial

Presenting Author: Dr. Yarlagadda Jane Jasmine, Senior Resident

Co-Authors: Dr. T. Parvathi, Associate Professor; Dr. Haritha Sagili, Professor

(Department of Obstetrics and Gyanecology, JIPMER, Puducherry, India)

Inclusion Criteria:

▪ Age > 18 years

▪ Period of gestation

39⁰/⁷ to 42 weeks

▪ Single live foetus with

cephalic presentation

with reactive Non

stress test

▪ Bishop score ≤ 6

▪ Intact membranes

▪ Unscarred uterus

▪ Planned for IOL

Exclusion Criteria:

▪ Absolute

contraindications for

vaginal delivery

▪ Patients requiring

imminent delivery

▪ Evidence of

chorioamnionitis

▪ Participants with

known

contraindications to

Mifepristone

Statistical Analysis:

Using STATA Software, Intention-To-Treat (ITT) and Per

Protocol analysis (PPA) were performed; p < 0.05

considered significant

RESULTS

REFERENCES

1. Leppert PC.Anatomy and physiology of cervical ripening.Clin Obstet Gynecol.1995 Jun;38(2):267-79. 00009.PMID: 7554594. doi: 10.1097/00003081-199506000

2. WHO recommendations: induction of labour at or beyond term.Geneva: World Health Organization; 2018.

3. Vogel JP, Osoti AO, Kelly A J, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labor induction in outpatient settings.Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701.doi:10.1002/14651858.CD007701.pub3. PMID:

28901007; PMCID: PMC6483740 Myers KM, Feltovich H, Mazza E, Vink J, Bajka M, Wapner RJ, Hall TJ, House M. The mechanical role of the cervix in pregnancy.JBiomech.2015 Jun 25;48(9):1511-23.doi: 10.1016/j.jbiomech.2015.02.065.Epub 2015 Mar

11.PMID: 25841293; PMCID: PMC4459908.

4. Wing DA, Fassett MJ, Mishell DR. Mifepristone for preinduction cervical ripening beyond 41 weeks’ gestation: a randomized controlled trial. Obstet Gynecol.2000 Oct;96(4):543-8. doi: 10.1016/s0029-7844(00)00947-9. PMID: 11004356.

5. Sharma C, Soni A, Gupta A, Verma A, Verma S. Mifepristone vs balloon catheter for labor induction in previous cesarean: a randomized controlled trial.Arch Gynecol Obstet.2017 Aug;296(2):241-248.doi: 10.1007/s00404-017-4431-8.Epub 2017 Jun

17.PMID: 28624988.

Primary Outcome

Change in Bishop's score at 24 and 48 hours of intervention

Secondary Outcomes

Maternal

Need for additional ripening/induction/augmentation

agents | Ripening to delivery interval (in hours) |

Maternal infection | I.C.U. admission |

Side-effects of the ripening method

Perinatal

Respiratory support | NICU admission | Neonatal

infection |

Death (intrapartum/ neonatal)

Mifepristone (n=133) Foley (n=133) p-value

Ripening to Delivery

interval (hours)

43.90 ± 29.84 46.22 ± 27.93 0.514

▪ Vaginal Delivery

▪ LSCS

104 (78.2%)

29 (21.8%)

114 (85.7%)

19 (14.3%)

0.329

Need for additional

agents:

▪ Ripening

▪ Induction

▪ Augmentation

13 (9.8%)

19 (14.5%)

52 (39.1%)

6 (4.5%)

28 (21%)

61 (45.9%)

0.089

0.383

0.264

Baseline Characteristics

Age, BMI, Parity, gestational age, pre-induction Bishop score, Indication for IOL, and

coexisting medical conditions were comparable between both the groups.

CONCLUSION

▪ Mifepristone (400mg) demonstrated comparable efficacy to

trans-cervical Foley catheter for pre-induction cervical ripening

in singleton term and late-term pregnancies.

▪ While it significantly increased the need for additional ripening

agents, it reduced the need for induction agents and Oxytocin.

▪ Two-thirds of women delivered within 48 hours, with

Mifepristone showing a shorter ripening-to-delivery interval.

▪ Mifepristone was associated with complications like uterine

hyperstimulation and antepartum hemorrhage, but the

overall safety profiles of both methods were comparable.