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A clinical trial to compare the concurrent use of vaginal misoprostol and transcervical foley catheter inflated with 60 ml vs 80 mlin nulliparous women at term for induction of labor

A randomized controlled trial to compare concurrent use of vaginal misoprostol and transcervical foley catheter inflated with 60 mL vs 80 mL in nulliparous pregnant women at term for induction of labor - FC8060

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036921
Enrollment
200
Registered
2021-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: To compare concurrent use of vaginal misoprostol and TCFC with 60 mL vs 80 mL in nulliparous pregnant women at term: All the women participating in study will be receiving 25 microgram

Sponsors

Dr RPGMC Kangra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Single live intrauterine fetus with cephalic presentation period of gestationgreater than equal to 40 weeks

Exclusion criteria

Exclusion criteria: women in spontaneous labor fetal malpresentation rupture of membranes previous uterine surgery multifetal gestation antepartum haemorrhage all contraindications to vaginal delivery(rachitic elvis, carcinoma cervix,CPD) Intruterine fetal death allergy to latex placenta vasa previa or cord presentation active genital herpes contraindications to prostaglandins any co morbid surgical illness Non reassuring fetal heart rate any previous attempt of IOLin present pregnancy

Design outcomes

Primary

MeasureTime frame
Induction delivery interval (defined as time from TCFC insertion to delivery of fetus)Timepoint: Induction delivery interval (defined as time from TCFC insertion to delivery of fetus)—

Secondary

MeasureTime frame
duration from IOL to active labourTimepoint: as mentioned above;duration of labor(defined as time from start of active phase until delivery of fetusTimepoint: as mentioned above;incidence of chorioamniontis Timepoint: during and post 48 hours of delivery;incidence of hyperstimulationTimepoint: not applicable;meconium stained liquorTimepoint: not applicable;neonatal outcomes(apgar score at 1 min and 5 min) neonatal intensive care admissionTimepoint: after delivery;proportion of women delivered vaginallyTimepoint: withi 12 to 24 hours of induction of labor;proportion of women with failure of IOLTimepoint: if there is no contraction or Bishop score less than 6 even after 5 doses of misoprostol;Proportion women undergoing CS Timepoint: after delivery of women;Time period between insertion of TCFC and spontaneous expulsion of TCFCTimepoint: maximum 12 hours after insrtion of TCFC after which it shall be removed—

Countries

India

Contacts

Public ContactDr C D Sharma

Dr R.P.G.M.C Tanda at Kangra

sakshijaryal@gmail.com8894219268

Outcome results

None listed

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