To compare Oral Mifepristone with Foley catheter for softening of cervix in women planned for delivery at or after 39 weeks of pregnancy

Comparison of efficacy of single-dose Oral Mifepristone with Transcervical Foley catheter for pre-induction cervical ripening in singleton term and late-term pregnancy - An Open-label Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034943

Enrollment

266

Registered

2021-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tablet Mifepristone: Tablet Mifepristone 400 mg orally will be given after examining the patient. Bishop score will be reassessed after 24 hours and 48 hours Control Intervention1: Tra

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Period of gestation: 39 to 42 weeks 3. Singleton live fetus with cephalic presentation with reactive Non-stress Test 4. Bishop’s score =6 5. Intact membranes 6. Planned for induction of labour 7. Unscarred uterus

Exclusion criteria

Exclusion criteria: 1.Absolute contraindications for vaginal delivery 2.Patient requiring imminent delivery 3. Evidence of chorioamnionitis 4.Patients with known contraindications to Mifepristone

Design outcomes

Primary

Measure	Time frame
To determine and compare the change in Bishop score with oral Mifepristone versus trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripeningTimepoint: Bishop score will be reassessed at 24 hours and 48 hours after administration of Tablet Mifepristone	—

Secondary

Measure	Time frame
To determine and compare the efficacy and safety of oral Mifepristone with trans-cervical Foley catheter in women with singleton term and late term pregnancy undergoing pre-induction cervical ripening Timepoint: From administration of Mifepristone and Transcervical Foley catheter insertion to delivery of the baby	—

Countries

India

Contacts

Public ContactT Parvathi

Jawaharlal Institute of Postgraduate Medical Education and Research

parvathinaik1@gmail.com9566537193

Outcome results