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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2021

Detailed Description

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

Interventions

  • Drug: 20mg oral propranolol and oxytocin
    • Participants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin
  • Drug: Oxytocin only
    • Participants will have outright augmentation or induction of labor with oxytocin

Arms, Groups and Cohorts

  • Active Comparator: PROPRANOLOL GROUP
    • Participants will receive 20mg of oral propranolol 10 minutes prior to initiation of augmentation or induction of labor with oxytocin
  • Placebo Comparator: OXYTOCIN ONLY GROUP
    • Participants had outright augmentation or induction of labor with oxytocin only

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

Inclusion Criteria

1. Nulliparous women selected for induction or augmentation of labour 2. Term pregnancy selected for induction or augmentation of labour 3. Normal singleton pregnancies with cephalic presenting foetuses. 4. Those who gave their consent. Exclusion Criteria:

1. Co-existing medical illnesses such as diabetes mellitus, cardiac disease, haemoglobinopathies, renal diseases, hypertensive disease, Bronchial asthma, 2. Women currently taking Propranolol or a chronic beta-blocker use 3. Contraindications to labour or vaginal delivery 4. Multiple gestations 5. Preterm labour 6. Chorioamnionitis 7. Known fetal anomalies 8. Abnormal fetal presentation. 9. Antepartum haemorrhage. 10. Contraindication to induction and augmentation of labour 11. Multi-party 12. Known allergy to propranolol

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Darlington-Peter Chibuzor Ugoji
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Darlington-Peter Chibuzor Ugoji, Principal Investigator – Alex Ekwueme Federal University Teaching Hospital
  • Overall Official(s)
    • UGOJI DR DARLINGTON-PETER, PART 1, Principal Investigator, ALEX EKWUEME FEDERAL UNIVERSITY TEACHING HOSPITAL, ABAKALIKI, EBONYI STATE, NIGERIA

References

Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.

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