Comparison of Intracervical Foleys catheter Buccal misoprostol and their combination for induction of labor

Comparison of Intracervical Foleys catheter, buccal misoprostol and their combination for induction of labor - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073383

Enrollment

132

Registered

2024-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Intracervical Foleys catheter for Induction of labor: Intracervical Foleys will be inflated with 30cc volume under all aseptic precautions and the catheter will be taped to the inner th

Eligibility

Inclusion criteria

Inclusion criteria: Women with Cephalic singleton pregnancy from 34 to 41 weeks with a specific indication for induction of labor such as Abruptio placenta , chorioamnionitis, gestational hypertension, preeclampsia, eclampsia, Prelabor rupture of membrane, postterm pregnancy, Diabetes mellitus, chronic hypertension, Fetal growth restriction, Oligohydraminos

Exclusion criteria

Exclusion criteria: Estimated fetal weight =1.500 kg to =3.5 kg. • Multifetal gestation • Non-reassuring fetal heart rate tracing • Poor biophysical profile • Congenital anomalies of the fetus • Intrauterine death of the fetus • Previous caesarean delivery or other uterine surgery (myomectomy, hysterotomy) • History of ante partum hemorrhage including placenta previa, vasa previa • Cephalopelvic disproportion • Any contraindication of vaginal delivery • Cervical cancer • History of cervical tear or any surgery • Contraindications & hypersensitivity to prostaglandins • Parity=5

Design outcomes

Primary

Measure	Time frame
The induction to active phase interval, induction-to-delivery interval. • Rate of successful vaginal birth within 24 hours. • Rate of caesarean section and operative vaginal deliveries.Timepoint: baseline	—

Secondary

Measure	Time frame
Maternal outcome: • Uterine hyperstimulation (defined as either tachysystole or hypertonus with a non reassuring fetal heart-rate pattern on cardiotocography). • Maternal infection (defined as a temperature = 38°C at any time during labour or delivery, wound infection either episiotomy or cesarean scar site, endometritis. • Primary Postpartum hemorrhage • Uterine rupture. Fetal outcome: • Still birth, Meconium aspiration syndrome & APGAR score. • Need of Neonatal intensive care (NICU). Timepoint: 6 weeks	—

Measure

Time frame

Maternal outcome: • Uterine hyperstimulation (defined as either tachysystole or hypertonus with a non reassuring fetal heart-rate pattern on cardiotocography). • Maternal infection (defined as a temperature = 38°C at any time during labour or delivery, wound infection either episiotomy or cesarean scar site, endometritis. • Primary Postpartum hemorrhage • Uterine rupture. Fetal outcome: • Still birth, Meconium aspiration syndrome & APGAR score. • Need of Neonatal intensive care (NICU). Timepoint: 6 weeks

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Countries

India

Contacts

Public ContactDr Sunita Dubey

Government Medical college and hospital, Chandigarh

sunitas504@gmail.com9646323268

Outcome results

None listed

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