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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05251610
Enrollment
110
Registered
2022-02-23
Start date
2020-11-02
Completion date
2021-04-30
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duration of Labor

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

Interventions

DRUG20mg oral propranolol and oxytocin

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

DRUGOxytocin only

Participants will have outright augmentation or induction of labor with oxytocin

Sponsors

Darlington-Peter Chibuzor Ugoji
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

clinical superiority open-labeled randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Induction/Augmentation delivery intervals at deliveryTime frame in minutes from the onset of initiation of Oxytocin to the delivery of the placentaLabor acceleration at delivery

Secondary

MeasureTime frameDescription
Maternal Blood pressure change in mmghChange over 30 minutesMaternal 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 secondsChange over 30 minutesFetal heart rate is checked prior to initiation of oxytocin and 30 minutes after initiation of oxytocin. the difference is noted

Countries

Nigeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026