跳至主要内容
临床试验/NCT05251610
NCT05251610已完成不适用

Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?

Darlington-Peter Chibuzor Ugoji1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年11月2日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Placebo Comparator

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

发起方
Darlington-Peter Chibuzor Ugoji
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Darlington-Peter Chibuzor Ugoji

Principal Investigator

Alex Ekwueme Federal University Teaching Hospital

研究点 (1)

Loading locations...

相似试验