Oral misoprostol compared to intracervical Foley catheter for induction of labour

Oral misoprostol for 48 hours versus an intracervical Foley catheter for 48 hours for induction of labour in post dated pregnancies : a randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2016/024

Enrollment

Unknown

Registered

2016-10-12

Start date

2016-10-17

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

Induction of labour

Interventions

Study setting: Antenatal ward of Academic Obstetric Unit, Teaching Hospital, Mahamodera Galle. Stratified (primiparous / multiparous) block randomisation, using computer generated random numbers and

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with uncomplicated pregnancies 2. 40 weeks + 5 days gestation 3. Modified Bishop score (MBS) of < 6 4. Singleton pregnancy 5. Cephalic presentation 6. Intact membranes

Exclusion criteria

Exclusion criteria: 1. Pregnancy induced hypertension 2. Gestational diabetes mellitus 3. Fetal growth restriction 4. Previous caesarean delivery 5. Scarred uterus 6. Hypersensitivity to misoprostol 7. Contraindication for a vaginal delivery

Design outcomes

Primary

Measure	Time frame
1. Number of women establishing labour or becoming favorable for induction of labour (IOL) with Modified Bishop’s Score (MBS) > 6 within 48 hours 2. Change in MBS after 48 hours of the intervention 3. Intervention to delivery time in those who established labour following intervention at 40 weeks + 5 days of gestation 4. The induction delivery interval (IDI),following IOL with antimony and oxytocin 48 hours after the interventions, in those favorable for IOL [After 48 hours of the intervention]	—

Measure

Time frame

1. Number of women establishing labour or becoming favorable for induction of labour (IOL) with Modified Bishop’s Score (MBS) > 6 within 48 hours 2. Change in MBS after 48 hours of the intervention 3. Intervention to delivery time in those who established labour following intervention at 40 weeks + 5 days of gestation 4. The induction delivery interval (IDI),following IOL with antimony and oxytocin 48 hours after the interventions, in those favorable for IOL [After 48 hours of the intervention]

—

Secondary

Measure	Time 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 • Uterine Hyperstimulation • Uterine rupture • Maternal infection during labour • Use of intravenous antibiotics 4. Fetal and Neonatal outcome and morbidity: • Suspicious cardiotocogram (CTG) • Pathological CTG • Birth weight • Meconium-stained liquor • APGAR scores < 5 at 1 minute • Admission to the neonatal ward / NICU and its reason [At the time of discharge of the mother and the baby from the hospital]	—

Measure

Time 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 • Uterine Hyperstimulation • Uterine rupture • Maternal infection during labour • Use of intravenous antibiotics 4. Fetal and Neonatal outcome and morbidity: • Suspicious cardiotocogram (CTG) • Pathological CTG • Birth weight • Meconium-stained liquor • APGAR scores < 5 at 1 minute • Admission to the neonatal ward / NICU and its reason [At the time of discharge of the mother and the baby from the hospital]

—

Countries

Sri Lanka

Contacts

Public ContactProfessor Malik Goonewardene

Senior Professor & Chair

malikg@eureka.lkTel: +94 91 2246878

Outcome results

None listed

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