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Outcome of induction of labour comparing double and single balloon catheters and Prostaglandin E2 Gel; an Open-label Trial.

Comparing the rate of caesarean sections in pregnant women receiving induction of labour with double balloon catheter, single balloon catheter and PGE2 gel; an open-label trial.'

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000299505
Enrollment
15
Registered
2024-03-21
Start date
2024-09-15
Completion date
2025-04-15
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

so our study will be the 1st to assess the efficacy and safety of standard treatment i.e PGE2 compared with double-balloon using two foleys catheters, single-balloon ( foleys catheter) devices and a combination of single balloon and PGE2 among women who underwent labour induction for postdate pregnancy. hypothesis - double balloon ( two foleys catheter ) and combined single balloon catheter with PGE2 is more safe and effective than single balloon or PGE2 used alone

Interventions

Arm 1 - induction of labour with single balloon catheter , it will be short procedure performed in labor room, 18-Fr Foley catheter will be inserted per vaginally above the internal os. The catheter bulb will be inflated with 60 ml of normal saline. After inflation, the catheter will be pulled back until the balloon is against the internal cervical os Arm 2- induction of labour with double balloon catheter it will be short procedure performed in labor room , two 18 F foleys catheter will be ti

Arm 1 - induction of labour with single balloon catheter , it will be short procedure performed in labor room, 18-Fr Foley catheter will be inserted per vaginally above the internal os. The catheter bulb will be inflated with 60 ml of normal saline. After inflation, the catheter will be pulled back until the balloon is against the internal cervical os Arm 2- induction of labour with double balloon catheter it will be short procedure performed in labor room , two 18 F foleys catheter will be tied to each other and inserted together in cervix per vaginally, one bulb will be extra amniotic, above the internal os, inflated with 60ml saline, 2nd the bulb will be placed in the cervix, inflated with 30ml saline Arm 4 - induction of labour with single single Balloon catherter & PGE2 a single bulb Foley catheter 18F will be placed above the internal os per vaginally, it will be inflated with 60 ml of normal saline, after 12 hours PGE2 Gel will be placed in the posterior fornix (2mg ,maximum 2 doses, 6 hours apart). The intervention will be done by final year resident / consultant obstetrician .

Sponsors

shahzadi saima hussain
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

single fetus between 37-42 weeks who need induction of labour for maternal or fetal reasons other than mentioned in exclusion criteria, BMI 20-35 Kg/m2, cephalic presentation, intact membrane, and reassuring CTG on admission

Exclusion criteria

fetus with meconium stained liqor, low-lying placenta defined as placental edge less than 2 cm from the internal os as measured by ultrasonography, pre-eclampsia, growth-restricted fetus, previously scarred uterus, estimated fetal weight of more than 4kg on ultrasound, uterine anomaly, intrauterine fetal demise, cephalopelvic disproportion and liquor abnormalities

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026