Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-27 @ 5:43 PM
Study NCT ID:
NCT06960850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin
Sponsor:
Federal Teaching Hospital Abakaliki
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: