Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propranolol, Placebo.
- Who it may be relevant to
- Registry conditions: Propranolol, Labour Induction. Basic parameters: 15 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial on the Effect of Oral Propranolol on Induction-Delivery Interval in Women Undergoing Oxytocin Induction of Labour in Abakaliki
Overview
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.
Interventions
- Drug 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. - Other 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.
Primary outcome measures
- Mean duration of first, second and third stage of labour [Time frame: 24 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Nigeria · 1 center
- Alex Ekwueme Federal University Teaching Hospital — Abakaliki
Identifiers
NCT: NCT06960850 · AE-FUTHA/REC/VOL3/2024/409