Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.
Eligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.
Participants will be randomly allocated to one of two treatment groups.
In the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.
In the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.
The study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.
Potential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.
The findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shahzadi Saima Hussain, MHR
- Phone Number: +923337111981
- Email: saima.hussain@lrh.edu.pk
Study Contact Backup
- Name: Dr Jawad Khan, PhD
- Phone Number: +92 334 9011681
- Email: mdrjawad@yahoo.com
Study Locations
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KPK
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Peshawar, KPK, Pakistan, 25000
- Lady Reading Hospital
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Contact:
- Dr Jawad Khan, PhD
- Phone Number: +92 334 9011681
- Email: mdrjawad@yahoo.com
-
Contact:
- Shezadi Saima Hussain, MHR
- Phone Number: +92 333 7111981
- Email: saima.hussain@lrh.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Exclusion Criteria:
- Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Concurrent Induction of Labour
Participants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter.
The Foley catheter balloon will be inflated with 30 mL of normal saline.
Both interventions will be initiated concurrently at the start of induction of labour.
|
A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
|
|
Active Comparator: Sequential Induction of Labour
Participants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later.
The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours.
|
A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time from initiation of induction of labour to vaginal delivery
Time Frame: From initiation of induction of labour until vaginal delivery, up to 24 hours
|
Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
|
From initiation of induction of labour until vaginal delivery, up to 24 hours
|
|
Successful vaginal delivery
Time Frame: From initiation of induction of labour until delivery, up to 24 hours
|
Proportion of participants who achieve vaginal delivery following induction of labour.
|
From initiation of induction of labour until delivery, up to 24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shahzadi Saima Hussain, MHR, Khyber Medical University Peshawar, Pakistan
- Study Director: Dr Jawad Khan, PhD, Khyber Medical University Peshawar, Pakistan
- Principal Investigator: Dr Mehnaz Faisal, MHPE, FCPS, Lady Reading Hospital Peshawar
Publications and helpful links
General Publications
- Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
- Eser A, Ozkaya E, Abide CY, Eser T, Eser GY, Abike F, Tayyar AT, Eroglu M. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019 Feb;299(2):451-457. doi: 10.1007/s00404-018-4998-8. Epub 2018 Dec 7.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KMU/DIR/CTU/2026/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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