Clinical trial NCT05251610: Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
Official title: Does Oral Propranolol Accelerate Labor Induction/Augmentation With Oxytocin in Nulliparous Women in Abakaliki?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duration of Labor
Lead sponsor: Alex Ekwueme Federal University Teaching Hospital
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 110
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical superiority open-labeled randomized controlled trial
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Induction/Augmentation delivery intervals at delivery
timeFrame: Time frame in minutes from the onset of initiation of Oxytocin to the delivery of the placenta
Secondary outcomes:
measure: Maternal Blood pressure change in mmgh
timeFrame: Change over 30 minutes
measure: Fetal heart rate change in seconds
timeFrame: Change over 30 minutes
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: AEFUTHA
state: Ebonyi
Study officials:
affiliation: ALEX EKWUEME FEDERAL UNIVERSITY TEACHING HOSPITAL, ABAKALIKI, EBONYI STATE, NIGERIA
name: UGOJI DR DARLINGTON-PETER, PART 1
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.