Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000299505
Ethics application status
Approved
Date submitted
18/08/2023
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcome of induction of labour comparing double and single balloon catheters and Prostaglandin E2 Gel; an Open-label Trial.
Scientific title
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.'
Secondary ID [1] 310375 0
nil
Universal Trial Number (UTN)
U1111-1296-5970
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
induction of labour 331116 0
Condition category
Condition code
Reproductive Health and Childbirth 327899 327899 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 .

Intervention code [1] 326772 0
Treatment: Devices
Intervention code [2] 326773 0
Treatment: Drugs
Comparator / control treatment

Arm 3- induction of labour with prostaglandin E2 ( PGE2)gel only
Prostaglandin E2 gel 2mg will be used, Gel will be placed in the posterior fornix, 6 hours apart, maximum three doses unless regular uterine contractions are commenced
Control group
Active

Outcomes
Primary outcome [1] 335744 0
rate of cesarean section verified by medical record
Timepoint [1] 335744 0
24-48 hours after intervention
Secondary outcome [1] 425434 0
indication of cesarean section verified by medical documentation
Timepoint [1] 425434 0
within 48 hour of intervention
Secondary outcome [2] 425435 0
mode of delivery verified by medical documentation
Timepoint [2] 425435 0
within 48 hour of intervention
Secondary outcome [3] 425436 0
failed induction verified by medical documentation
Timepoint [3] 425436 0
within 24 hour of intervention
Secondary outcome [4] 425437 0
the Time duration between insertion and expulsion of catheters verified by medical documentation
Timepoint [4] 425437 0
within 24 hours
Secondary outcome [5] 425438 0
pain score on insertion of catherter will be noticd using visual analog scale
Timepoint [5] 425438 0
at time of insertion of catheter
Secondary outcome [6] 425439 0
Cervical readiness for labour determined by bishop score before and after expulsion of cathete
Timepoint [6] 425439 0
within 24 hour of intervention
Secondary outcome [7] 425440 0
time from insertion to delivery verified by medical documentation
Timepoint [7] 425440 0
within 24-48 hours after intervention
Secondary outcome [8] 425441 0
frequency of hyperstimulation of uterus measured as more than 4 contractions in 10 minutes Lasting more than 40 seconds
Rate of uterine rupture secondary to hyperstimulation determined by clinical assessment'
Timepoint [8] 425441 0
within 24-48 hours after intervention
Secondary outcome [9] 425442 0
postpartum haemorrhage (PPH) via amount of blood loss after delivery , blood loss of more than 500ml after Normal Vaginal Deliveries (NVD) and more than 1000 ml after Casearean Section( Cs ) will be considered as PPH, blood loss will be estimated by weighing surgical guaze packs used , pre and post delivery, 1mg increase in weight equals to 1ml blood loss
Timepoint [9] 425442 0
within 24-48 hour of delivery
Secondary outcome [10] 430339 0
fever via clinical assessment , verified by medical documentation.
Timepoint [10] 430339 0
24-48 hours after intervention

Eligibility
Key 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
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size was calculated using, Open Epi, Version 3, open-source calculator-as 122 patients in each group (488 total), keeping the power of study as 80%, Two-sided significance level (1-alpha):95, the ratio of exposed to unexposed as 1, percent of unexposed with outcome 15, percent of exposed with the outcome as 30.

reference . Pennell CE, Henderson JJ, O’Neill MJ, McCleery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG: an international journal of obstetrics & gynaecology. 2009 Oct;116(11):1443-52.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
15/04/2025
Actual
Date of last data collection
Anticipated
15/04/2025
Actual
Sample size
Target
488
Accrual to date
Final
Recruitment outside Australia
Country [1] 25717 0
Pakistan
State/province [1] 25717 0
khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 314577 0
Hospital
Name [1] 314577 0
lady reading hospital ,peshawar kp
Country [1] 314577 0
Pakistan
Primary sponsor type
Individual
Name
shahzadi saima hussain
Address
Lady Reading Hospital MTI, Gynae/ obs building , PTCL Colony, Peshawar, Khyber Pakhtunkhwa 25000, Pakistan.'
Country
Pakistan
Secondary sponsor category [1] 316539 0
None
Name [1] 316539 0
none
Address [1] 316539 0
none
Country [1] 316539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313612 0
LADY READING HOSPITAL MEDIAL TEACHING INSTITUTION , INSTITITIONAL REVIEW BOARD
Ethics committee address [1] 313612 0
'Lady Reading Hospital, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan'
Ethics committee country [1] 313612 0
Pakistan
Date submitted for ethics approval [1] 313612 0
21/07/2023
Approval date [1] 313612 0
03/08/2023
Ethics approval number [1] 313612 0
866/LRH/MTI

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128746 0
A/Prof shahzadi saima hussain
Address 128746 0
Lady Reading Hospital, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
Country 128746 0
Pakistan
Phone 128746 0
+92 3337111981
Fax 128746 0
Email 128746 0
[email protected]
Contact person for public queries
Name 128747 0
A/Prof shahzadi saima hussain
Address 128747 0
Lady Reading Hospital, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
Country 128747 0
Pakistan
Phone 128747 0
+92 3337111981
Fax 128747 0
Email 128747 0
[email protected]
Contact person for scientific queries
Name 128748 0
A/Prof shahzadi saima hussain
Address 128748 0
Lady Reading Hospital, Soekarno Rd, PTCL Colony Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
Country 128748 0
Pakistan
Phone 128748 0
+92 3337111981
Fax 128748 0
Email 128748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.