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Comparison of safety and efficacy of chemical method vs mechanical method in inducing labour pains in a term pregnant mother

Comparative study of safety and efficacy of intracervical Foley catheter balloon versus prostaglandin E2 gel for induction of labour in unfavourable cervix

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027093
Enrollment
100
Registered
2020-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Cervical ripening for induction of labour in unfavourable cervix: 18FG Foleys catheter balloon applied intracervically. Inflated with 30-50ml distilled water Reassess for cervical cha

Sponsors

Dr Maya menon
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primigravida, more than 37weeks gestation, singleton pregnancy, cephalic presentation, bishops score less than 5, intact membranes, reactive preinduction CTG

Exclusion criteria

Exclusion criteria: Multiple pregnancy, malpresentation, absent membranes, antepartum hemorrhage, previous uterine scar, active genital infections, major CPD, Medical conditions like heart disease

Design outcomes

Primary

MeasureTime frame
Post induction bishops scoreTimepoint: 12 hours

Secondary

MeasureTime frame
Mean induction to delivery interval Mode of delivery Maternal and fetal outcomeTimepoint: 12 to 36hours

Countries

India

Contacts

Public ContactAnjani Devi S

The Tamilnadu Dr. MGR medical university

mayasree@gmail.com9444477791

Outcome results

None listed

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