Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy

NCT07821099 | Not Yet Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/12
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods. The study will assess whether using both methods concurrently is more effective and safe than using them sequentially. The primary focus is the rate of vaginal delivery within 24 hours after initiation of induction. Participants will be women with term pregnancy (37-42 weeks) admitted for induction of labour without significant comorbidities.

Conditions

Induced; Birth

Keywords

Vaginal delivery; Sequential induction; Cervical ripening; Induction of labor

Outcome Measures

Primary Outcomes (2)

• Time from initiation of induction of labour to vaginal delivery

  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

  Proportion of participants who achieve vaginal delivery following induction of labour.

  From initiation of induction of labour until delivery, up to 24 hours

Study Arms (2)

Concurrent Induction of Labour

EXPERIMENTAL

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.

Device: Foley Catheter; Drug: PGE2 Vaginal Pessary

Sequential Induction of Labour

ACTIVE COMPARATOR

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.

Device: Foley Catheter; Drug: PGE2 Vaginal Pessary

Interventions

Foley Catheter DEVICE

A Foley catheter will be used for mechanical cervical ripening. The balloon will be inflated with 30 mL of normal saline.

Concurrent Induction of Labour; Sequential Induction of Labour

PGE2 Vaginal Pessary DRUG

A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.

Concurrent Induction of Labour; Sequential Induction of Labour

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Lady Reading Hospital

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 31623014 BACKGROUND

• 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.

  PMID: 22419277 BACKGROUND

• 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.

  PMID: 23303106 BACKGROUND

• 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.

  PMID: 30536117 BACKGROUND

Study Officials

• Shahzadi Saima Hussain, MHR

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

• Dr Jawad Khan, PhD

  Khyber Medical University Peshawar, Pakistan

  STUDY DIRECTOR

• Dr Mehnaz Faisal, MHPE, FCPS

  Lady Reading Hospital Peshawar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahzadi Saima Hussain, MHR

CONTACT

+923337111981; saima.hussain@lrh.edu.pk

Dr Jawad Khan, PhD

CONTACT

+92 334 9011681; mdrjawad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label randomized controlled trial. Participants, care providers, investigators, and outcomes assessors are not masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to one of two parallel intervention groups: concurrent induction using Foley catheter plus PGE2 vaginal pessary, or sequential induction using Foley catheter followed by PGE2 vaginal pessary 12 hours later.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 20, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)