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

Not Applicable

Completed

• Conditions: Duration of Labor
• Interventions: Drug: 20mg oral propranolol and oxytocin; Drug: Oxytocin only

• Registration Number: NCT05251610
• Lead Sponsor: Darlington-Peter Chibuzor Ugoji

Brief Summary

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.

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

Study Timeline

• Study Start: 2020-11-02
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Study First Submitted: 2021-09-22
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PROPRANOLOL GROUP	20mg oral propranolol and oxytocin	Participants will receive 20mg of oral propranolol 10 minutes prior to initiation of augmentation or induction of labor with oxytocin
OXYTOCIN ONLY GROUP	Oxytocin only	Participants had outright augmentation or induction of labor with oxytocin only

Primary Outcome Measures

Name	Time	Method
Induction/Augmentation delivery intervals at delivery	Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta	Labor acceleration at delivery

Secondary Outcome Measures

Name	Time	Method
Maternal Blood pressure change in mmgh	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	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

Trial Locations

Locations (1)

AEFUTHA; 🇳🇬 Abakaliki, Ebonyi, Nigeria