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OpenTrials
Completed

NCT Number: NCT05251610

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

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.

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Key information

Conditions

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AEFUTHA

Abakaliki, Ebonyi State, 234, Nigeria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

20mg oral propranolol and oxytocin

Drug

Participants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin

Oxytocin only

Drug

Participants will have outright augmentation or induction of labor with oxytocin

Primary outcomes

  1. Induction/Augmentation delivery intervals at delivery

    Time frame: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta

    Labor acceleration at delivery

Secondary outcomes

  1. Maternal Blood pressure change in mmgh

    Time frame: Change over 30 minutes

    Maternal Blood pressure is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted

  2. Fetal heart rate change in seconds

    Time frame: Change over 30 minutes

    Fetal heart rate is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted

Sponsors and collaborators

Lead sponsor

Darlington-Peter Chibuzor Ugoji

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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