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A comparative study between two methods of induction of labor pains, mechanical method (by insertion of Foley catheter) and chemical method ( by using dinoprostone gel) by inserting them in cervix of pregnant women .

Comparison of Foley balloon catheter with intracervical dinoprostone gel for induction of labor in nulliparous women.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035072
Enrollment
240
Registered
2021-07-23
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

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium Health Condition 2: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium

Interventions

Intervention1: cervigel insertion and Foley insertion: Comparison of induction of labour by using cervigel and Foley catheter Control Intervention1: Foley catheter and dinoprostone gel: Intracervical

Sponsors

VMMC and SAFDARJUNG HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy Bischop score Intact membrane Reactive NST

Exclusion criteria

Exclusion criteria: Scarred uterus ,Fetal anomalies ,IUD ,severe preeclampsia , APH , cervicovaginal discharge , Asthma , Jaundice , Glaucoma ,Heart Disease

Design outcomes

Primary

MeasureTime frame
Induction Delivery IntervalTimepoint: 6to12 hour

Secondary

MeasureTime frame
Change in Bishops score at 12 hours Failed induction Hyperstimulation Tachysystole Fetal distress Chorioamnitis Febrile morbidity C_section requirement Maximum dose of oxytocin required Neonatal complications 1.APGAR at birth 2. Requirement for NICU careTimepoint: 12hour

Countries

India

Contacts

Public ContactANURADHA SHARMA

VMMC and Safdarjung hospital New Delhi

jyotsnasuri@gmail.com98100858358

Outcome results

None listed

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