A study to compare two methods for starting the process of delivery of baby

A randomised trial to compare vaginal dinoprostone pessary with transcervical balloon catheter plus vaginal misoprostol for pre-induction cervical ripening

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036894

Enrollment

100

Registered

2021-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: O618- Other failed induction of labor

Interventions

Intervention1: methods for induction of labor Transcerival Foley catheter plus vaginal misoprostol and intravaginal dinoprostone pessary: Methods for induction of labor Transcervial Ballon catheter -F

Eligibility

Inclusion criteria

Inclusion criteria: • Singleton pregnancy with cephalic presentation • Period of gestation >34 weeks • Bishop score • Reactive non stress test • Absence of true labor pains • Intact membranes

Exclusion criteria

Exclusion criteria: Uterine scar â?? Ante-partum Haemorrhage (APH) â?? Intra uterine fetal demise (IUFD) â?? Cervicovaginal infection â?? Severe fetal growth restriction (estimated fetal birth weight â?? Parity >3 â?? Heart disease, seizure disorder, severe anaemia, uncontrolled diabetes mellitus â?? Past history of uterine hyperstimulation, glaucoma, asthma

Design outcomes

Primary

Measure	Time frame
To compare the induction delivery interval (IDI) with the two methods used for pre-induction cervical ripening a. Intravaginal dinoprostone pessary (10mg) b. Transcervical Foley catheter plus vaginal Misoprostol Timepoint: from time to induction to time of delivery of baby ( within 24 to 48 hours )	—

Secondary

Measure	Time frame
To compare 1. Change in Bishop score 2. Caesarean section (CS) rate 3. Rate of uterine tachysystole 4. Neonatal outcome [ Apgar score at 1 and 5 minutes, need of resuscitation, extent of resuscitation, perinatal asphyxia, meconium aspiration syndrome, need for respiratory support, need for neonatal intensive care unit (NICU) stay, neonatal sepsis, mortality] 5.Visual Analog Scale (VAS) score after instillation of cervical ripening agent Timepoint: Every 6 hours after instillation of agent	—

Measure

Time frame

To compare 1. Change in Bishop score 2. Caesarean section (CS) rate 3. Rate of uterine tachysystole 4. Neonatal outcome [ Apgar score at 1 and 5 minutes, need of resuscitation, extent of resuscitation, perinatal asphyxia, meconium aspiration syndrome, need for respiratory support, need for neonatal intensive care unit (NICU) stay, neonatal sepsis, mortality] 5.Visual Analog Scale (VAS) score after instillation of cervical ripening agent Timepoint: Every 6 hours after instillation of agent

—

Countries

India

Contacts

Public ContactDrVanita Jain

Post Graduate Institute Of Medical Education and R

drvanitajain@yahoo.com9914209352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026