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A clinical study to compare the combined efficacy of mechanical and pharmacological methods versus pharmacological method alone when used for induction of labor.

A randomized clinical trial comparing cervical Foleys catheter plus vaginal misoprostol versus vaginal misoprostol alone for induction of labor

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003265
Enrollment
126
Registered
2012-12-27
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: null- Labor induction in pregnancy

Interventions

Intervention1: Foley catheter, Tab. Misoprostol: 16Fr Foley catheter with 30ml normal saline for a maximum of 12 hours or spontaneous expulsion combined with Tab. Misoprostol 25mcg every 4 hours upto

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy corresponding to gestational age of 28 weeks or more Intact membranes Absence of labor Cephalic presentation Bishop score 4 or less Volunteering to participate

Exclusion criteria

Exclusion criteria: Multifetal gestation Lethal fetal anomaly Gravida 5 or more Non-reassuring FHR tracings Ruptured membranes Previous uterine surgery Low lying placenta Active genital infection Chorioamnionitis Previous induction during the pregnancy Intrauterine fetal death Estimated fetal weight more than 4000gm Thyrotoxicosis, heart disease, bronchial asthma, Sickle cell disease, glaucoma Unwillingness to participate

Design outcomes

Primary

MeasureTime frame
Induction to delivery interval Rate of vaginal delivery Timepoint: N/A

Secondary

MeasureTime frame
Uterine tachysystole Uterine hyperstimulation Rate of caesarean section Neonatal outcome - birth weight, Apgar scores at 1 and 5 minutes, NICU admissions ChorioamnionitisTimepoint: N/A

Countries

India

Contacts

Public ContactDr Tarakeswari S

Fernandez Hospital

srilulanka@yahoo.com040-40222447

Outcome results

None listed

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