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A clinical trial evaluating labor induction in pregnant women with simultaneous versus sequential use of trans-cervical (inserted in cervix) foley catheter and misoprostol

Sequential versus simultaneous use of High- volume Foley’s Catheter and Misoprostol for Induction of Labour: A Randomised Control Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059372
Enrollment
200
Registered
2023-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: O610- Failed medical induction of labor

Interventions

Intervention1: Group 2 (Simultaneous misoprostol vaginally & trans- cervical foleys catheter): Women in both groups will undergo insertion of FC (18- french) through the cervix into the extra-amniotic

Sponsors

Free Maternity Services Government of India under National Health Mission
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All nulliparous women with unfavorable cervix (Bishop score <6) planned for IOL. Inclusion criteria will be ; age 18 to 40 years and singleton-term pregnancy (=38 weeks).

Exclusion criteria

Exclusion criteria: spontaneous labor; Bishop score =6; fetal malpresentation; non-reassuring fetal heart rate; any previous uterine surgery (CD/hysterotomy, myomectomy, or metroplasty); multifetal gestation; antepartum hemorrhage; intrauterine fetal demise; rupture of membranes; placenta previa or vasa previa, or cord presentation; active genital herpes; severe pre-eclampsia, GDM on pharmacological treatment any contraindication to vaginal delivery; allergy to latex; any contraindication to prostaglandins; any medical illness such as asthma, cardiac disease, known bleeding disorder, concurrent anticoagulant therapy, pelvic infection, any comorbid surgical illness (eg, nephrolithiasis, cholelithiasis); or any previous attempt of IOL in the present pregnancy)

Design outcomes

Primary

MeasureTime frame
Induction delivery intervalTimepoint: after delivery of the baby (variable period as per duration of labor)

Secondary

MeasureTime frame
duration of the latent phase of laborTimepoint: after delivery of the baby (as per duration of labor);number of doses of vaginal misoprostol requiredTimepoint: after delivery of the baby (as per duration of labor);mode of deliveryTimepoint: after delivery of the baby (as per duration of labor);maternal & neonatal morbidityTimepoint: after delivery of the baby (as per duration of labor)

Countries

India

Contacts

Public ContactChanderdeep Sharma

All India Institute of Medical Sciences Bilaspur HP

cdsharma2021@gmail.com9816326544

Outcome results

None listed

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