Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin

NCT ID: NCT06960850

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-01

Brief Summary

Prolonged pregnancy could lead to perinatal and maternal complications. Oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour. The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin

Detailed Description

Background: Prolonged pregnancy could lead to perinatal and maternal complications. To prevent this, induction of labour becomes necessary. Conventionally, oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour.

Aim: The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin.

Methodology: This will be double-blind, superiority randomised controlled trial involving pregnant women at term who meet the inclusion criteria and consent to the study over a six-month period. The participants will be randomised by means of computer-generated numbers from a pool of 308 participants. A set of 154 numbers will receive oxytocin + propranolol once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration; while the other set of 154 numbers would be given oxytocin + placebo once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration.Labour will be monitored with the labour care guide.

Conditions

Propranolol; Labour Induction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Propranolol

A set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

A set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Placebo

A set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Interventions

Propranolol

A set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Intervention Type: DRUG

Placebo

A set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. the first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• singleton foetus
• cephalic presentation at term

Exclusion Criteria

• Patients on beta blockers
• Contraindications to labour or vaginal delivery
• Multiple gestations
• Preterm labour
• Chorioamnionitis
• Known fetal anomalies
• Bronchial asthma
• Abnormal fetal presentation.
• Antepartum haemorrhage.
• Lung disease
• Previous uterine scar or surgery.
• Foetal heart irregularity

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assumpta Nnenna Nweke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

AE-FUTHA/REC/VOL3/2024/409

Identifier Type: -

Identifier Source: org_study_id