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

Darlington-Peter Chibuzor Ugoji

Status: Completed

Conditions: Duration of Labor

Treatments: Drug: 20mg oral propranolol and oxytocin; Drug: Oxytocin only

Study type: Interventional

Funder types: Other

Identifiers

NCT05251610

FETHA/REC/VOL2/2019/277

Details and patient eligibility

About

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.

Full 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

Enrollment: 110 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

PROPRANOLOL GROUP

Active Comparator group

Description:

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

Treatment:

Drug: 20mg oral propranolol and oxytocin

OXYTOCIN ONLY GROUP

Placebo Comparator group

Description:

Participants had outright augmentation or induction of labor with oxytocin only

Treatment:

Drug: Oxytocin only