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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07821099
Enrollment
128
Registered
2026-09-15
Start date
2026-09-14
Completion date
2027-03-20
Last updated
2026-09-15

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

Conditions

Induced; Birth

Keywords

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

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.

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.

Interventions

DEVICEFoley Catheter

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

DRUGPGE2 Vaginal Pessary

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

Sponsors

Khyber Medical University Peshawar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This is an open-label randomized controlled trial. Participants, care providers, investigators, and outcomes assessors are not masked to treatment allocation.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time from initiation of induction of labour to vaginal deliveryFrom initiation of induction of labour until vaginal delivery, up to 24 hoursTime interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
Successful vaginal deliveryFrom initiation of induction of labour until delivery, up to 24 hoursProportion of participants who achieve vaginal delivery following induction of labour.

Countries

Pakistan

Contacts

CONTACTShahzadi Saima Hussain, MHR
saima.hussain@lrh.edu.pk+923337111981
CONTACTDr Jawad Khan, PhD
mdrjawad@yahoo.com+92 334 9011681
PRINCIPAL_INVESTIGATORShahzadi Saima Hussain, MHR

Khyber Medical University Peshawar, Pakistan

STUDY_DIRECTORDr Jawad Khan, PhD

Khyber Medical University Peshawar, Pakistan

PRINCIPAL_INVESTIGATORDr Mehnaz Faisal, MHPE, FCPS

Lady Reading Hospital Peshawar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026