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

NCT06960850 | Not Yet Recruiting

• 1 other identifier: AE-FUTHA/REC/VOL3/2024/409
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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

Conditions

Propranolol; Labour Induction

Keywords

Propanolol; Induction-Delivery; Oxytocin; Labour Induction

Outcome Measures

Primary Outcomes (1)

• Mean duration of first, second and third stage of labour

  this is to assess the mean duration of the first, second and third stages of labour

  24 hours

Study Arms (2)

Propranolol

EXPERIMENTAL

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.

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Propranolol 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.

Propranolol

Placebo 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.

Placebo

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• singleton foetus
• cephalic presentation at term

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)