Induced; Birth
Conditions
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
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.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Time from initiation of induction of labour to vaginal delivery | 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. |
| Successful vaginal delivery | From initiation of induction of labour until delivery, up to 24 hours | Proportion of participants who achieve vaginal delivery following induction of labour. |
Countries
Pakistan
Contacts
Khyber Medical University Peshawar, Pakistan
Khyber Medical University Peshawar, Pakistan
Lady Reading Hospital Peshawar