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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorKhyber Medical University Peshawar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foley Catheter

    Device

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

  • PGE2 Vaginal Pessary

    Drug

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

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Concurrent Induction of LabourExperimental treatment 2 interventions
Group B: Sequential Induction of LabourActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From initiation of induction of labour until vaginal delivery, up to 24 hours
2

Successful vaginal delivery

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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