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induction of labour with foleys catheter placed intracervically

a randomized controlled trial on Comparision of labour induction with foleys inflated to 30 ml and 60 ml in nulliparous postdate women

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019282
Enrollment
200
Registered
2019-05-23
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: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Not applicable : Not applicable Control Intervention1: intracervical foleys catheter: intracervical foleys catheter induction of labour with balloon inflated to 30 ml compare with foley

Sponsors

State government
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy Vertex presentation Intact membranes Bishop score Women not in spontaneous labour Maternal age 18-40 years Period of gestation >= 40 completed weeks

Exclusion criteria

Exclusion criteria: 1.Patient has regular contractions on admission 2.Rupture of the membranes 3.Previous uterine scar 4.Multiparity of more than 5 deliveries 5.Vaginal infection 6.Antepartum bleeding 7.Intrauterine fetal death 8.Anomalous fetus 9.Allergy to latex 10.All contraindications to vaginal delivery. 11.A previous attempted induction of labor during the current pregnancy 12.Placenta or vasa previa or cord presentation 13.Abnormal fetal lie or presentation (e.g. transverse lie,footling breech) 14.Active genital herpes 15.Cephalo pelvic disproportion 16.Gestational age

Design outcomes

Primary

MeasureTime frame
Measurement of duration of labour in both the groups Time zero is defined as the time of Foley catheter placement and balloon inflation. Number of deliveries within 12 hrs of placement of Foleys catheter. Timepoint: Delivery within 12 hrs of induction of labour 4 hourly bishop score and proggress of labour will be assesed

Secondary

MeasureTime frame
1.Mode of delivery within 12 hours Vaginal,Instrumental, Caesearean 2.Total Duration of Labour 3.Time to Foleys Balloon Expulsion 4.Cervical Dilatation after Foley balloon Expulsion 5.Time to Active Labour 6.Chorioamnionitis 7.Uterine Hyperstimulation 8.Meconium Stained Liquor 9.Birth Asphyxia 5 minute Apgar7 9.Neonatal Intensive Care Unit Admission 10.Cervix Unfavourable/Unchanged after 12â??24 hours 11.Oxytocin Augmentation Timepoint: Mode of delivery within 12 hours of induction of labour Bishop score and progress of labour assesed 4hrly FHR half hourly Uterine contractions hourly

Countries

India

Contacts

Public ContactDr Chanderdeep Sharma

dr. RPGMC tanda

cdsharma2006@gmail.com

Outcome results

None listed

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