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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Duration of Labor

Intervention / Treatment
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* Drug: 20mg oral propranolol and oxytocin
* Drug: Oxytocin only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clinical superiority open-labeled randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PROPRANOLOL GROUP<br>Participants will receive 20mg of oral propranolol 10 minutes prior to initiation of augmentation or induction of labor with oxytocin | Drug: 20mg oral propranolol and oxytocin<br>* Participants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin<br>|
| Placebo Comparator: OXYTOCIN ONLY GROUP<br>Participants had outright augmentation or induction of labor with oxytocin only | Drug: Oxytocin only<br>* Participants will have outright augmentation or induction of labor with oxytocin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction/Augmentation delivery intervals at delivery | Labor acceleration at delivery | Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Blood pressure change in mmgh | Maternal Blood pressure is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted | Change over 30 minutes | 
| Fetal heart rate change in seconds | Fetal heart rate is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted | Change over 30 minutes |