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Comparison of oral misoprostol vs intracervical Foley catheter for 24 hours for preparation of uterine cervix before induction of labour

A randomized control trial to compare the effectiveness of intracervical Foley catheter for 24 hours vs three doses of oral misoprostol for preinduction cervical ripening in post dated pregnancies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2014/030
Enrollment
Unknown
Registered
2014-11-21
Start date
2014-11-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Cervical ripening

Interventions

Using computer generated random numbers, a stratified (primip/multip) block randomization technique and sequentially numbered sealed opaque envelopes, women fulfilling the inclusion criteria admitted

Sponsors

Department of Obstetrics & Gynecology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with uncomplicated pregnancies at 40 weeks+ 6 days gestation with a Modified Bishop score (MBS)<5 2. Having a singleton fetus in a cephalic presentation

Exclusion criteria

Exclusion criteria: 1. Pregnancy Induced Hypertension 2. Gestational Diabetes Mellitus 3. Multiple pregnancies 4. Planned Caesarean section, 5. Fetal Growth Restriction , 6. Scarred uteruses

Design outcomes

Primary

MeasureTime frame
1.Number of women establishing spontaneous onset of labour (SOL) within 24 hours of the interventions. 2.MBS after 24 hours of the interventions 3.The change of MBS after 24 hours of the interventions 4.Number of women with MBS> 7 after 24 hours of the interventions 5.The induction delivery interval following Induction of labor (IOL) with amniotomy and oxytocin intravenous infusion,24 hours after the interventions, in those favourable for IOL [After 24 hours of the interventions]

Secondary

MeasureTime frame
1. Mode of delivery and the reason for operative delivery 2. Oxytocin use 3. Maternal morbidity • Post partum blood transfusion and number of packed cells • Tachysystole • Hyperstimulation • Uterine rupture • Maternal infection during labour • Use of intravenous antibiotics 4. Fetal and Neonatal outcome and morbidity: • Fetal tachycardia • Weight at birth • Meconium-stained liquor • Apgar scores <5 at 1 minute • Admission to the neonatal ward/NICU and its reason [Between 24 to 48 hours after the intervention]

Countries

Sri Lanka

Contacts

Public ContactPofessor Malik Goonewardene

Senior professor & Head

malkg@ureka.lk+94 91 2246878

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026