Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Induction/Augmentation delivery intervals at delivery
研究概览
简要总结
Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse effects in labour have been shown to decreases the duration of labour when used in synergy with oxytocin. However, the paucity of information on the use of propranolol in labour.
详细描述
ABSTRACT Background: Labour is usually physiologic, spontaneous and progressive, but occasionally, there may be the need for induction or augmentation of labour especially in nulliparous women, who are at increased risk of dysfunctional labour. Oxytocin traditionally has been used for induction and augmentation of labour however prolonged labour continued to occur with attendant sequelae. Newer agents like propranolol, with minimal to no maternal and fetal adverse effects in labour have been shown to decreases the duration of labour when used in synergy with oxytocin. However, the paucity of information on the use of propranolol in labour.
Methodology: This research was a superiority open labelled randomized controlled trial that involved only nulliparous women who met the inclusion criteria and gave consent to the study. There was daily recruitment of participants. Randomization was by utilizing computer-generated numbers from a pool of 110 participants divided into A and B. Group A received 20 mg of oral propranolol before initiation of oxytocin titration. Group B received only oxytocin titration. Partograph was used to monitor their labour.
Analysis: Absolute and relative frequencies of categorical variables, mean, range and standard deviation of continuous variables were calculated. Continuous variables were analyzed using students t-test while chi-square (χ2) test was used for categorical variables. A P-value of <0.05 was considered significant.
Keywords: Propranolol, Labour, Induction, Augmentation, Nullipara
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women selected for induction or augmentation of labour
- •Term pregnancy selected for induction or augmentation of labour
- •Normal singleton pregnancies with cephalic presenting foetuses.
- •Those who gave their consent.
排除标准
- •Co-existing medical illnesses such as diabetes mellitus, cardiac disease, haemoglobinopathies, renal diseases, hypertensive disease, Bronchial asthma,
- •Women currently taking Propranolol or a chronic beta-blocker use
- •Contraindications to labour or vaginal delivery
- •Multiple gestations
- •Preterm labour
- •Chorioamnionitis
- •Known fetal anomalies
- •Abnormal fetal presentation.
- •Antepartum haemorrhage.
- •Contraindication to induction and augmentation of labour
- •Multi-party
- •Known allergy to propranolol
研究组 & 干预措施
PROPRANOLOL GROUP
Participants will receive 20mg of oral propranolol 10 minutes prior to initiation of augmentation or induction of labor with oxytocin
干预措施: 20mg oral propranolol and oxytocin (Drug)
OXYTOCIN ONLY GROUP
Participants had outright augmentation or induction of labor with oxytocin only
干预措施: Oxytocin only (Drug)
结局指标
主要结局
Induction/Augmentation delivery intervals at delivery
时间窗: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta
Labor acceleration at delivery
次要结局
- Maternal Blood pressure change in mmgh(Change over 30 minutes)
- Fetal heart rate change in seconds(Change over 30 minutes)
研究者
Darlington-Peter Chibuzor Ugoji
Principal Investigator
Alex Ekwueme Federal University Teaching Hospital
