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Insertion of Foley catheter to uterine cervix versus oral misoprostol for preparation of uterine cervix for induction of labour in post dated pregnancies

Intra cervical Foley catheter versus oral misoprostol for pre induction cervical ripening of post dated pregnancies. A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2011/002
Enrollment
150
Registered
2011-01-17
Start date
2011-02-01
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

Effects of Foley catheter versus oral misoprostol for pre-induction cervical ripening

Interventions

Women will be randomly allocated to two groups by using stratified (primi/multi) block randomization at 40 weeks and 6 days. One group will have the Foley catheter inserted and the other group will ha

Sponsors

University of Ruhuna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive women with uncomplicated singleton pregnancies having a cephalic presentation at period of gestation of 40 weeks and 6 days

Exclusion criteria

Exclusion criteria: Complicated pregnancies – both maternal or fetal complications. Pregnancies with uncertain dates not confirmed by early scan, even though clinically considered as 41 weeks. Multiple pregnancies. Pregnancies with contraindication for normal vaginal delivery. Pregnancies with previous caesarean section. Women who have had insertion of intra cervical Foley catheter or vaginal PGE2 before 40 + 6 days. Contraindication for the use of misoprostol.

Design outcomes

Primary

MeasureTime frame
Proportions establishing labour by day two after the intervention [Morning of day 2] Proportions of women suitable for induction of labour with modified Bishop score (mBS) 6 or more by day two after the intervention [Morning of day 2] Induction to delivery interval [Morning of day 2]

Secondary

MeasureTime frame
Induction to delivery interval [After delivery] Mode of delivery [After delivery ] Side effects of misoprostol therapy [After delivery ]

Countries

Sri Lanka

Contacts

Public ContactProf. Malik Goonewardene

Senior Professor and Head of the Dept. of Obstetrics and Gynaecology

malikg@eureka.lk(091) 2246878, 2234801/3, 2234730 (091) 2222314, Int: (+94)

Outcome results

None listed

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