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

Официальное название

A Randomized Controlled Trial on the Effect of Oral Propranolol on Induction-Delivery Interval in Women Undergoing Oxytocin Induction of Labour in Abakaliki

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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.
• Другое 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.

Первичные конечные точки

• Mean duration of first, second and third stage of labour [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• singleton foetus
• cephalic presentation at term

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Nigeria · 1 центр

• Alex Ekwueme Federal University Teaching Hospital — Abakaliki

Идентификаторы

NCT: NCT06960850 · AE-FUTHA/REC/VOL3/2024/409

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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