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

NCT ID: NCT05251610

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2021-04-30

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

Conditions

Duration of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PROPRANOLOL GROUP

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

Group Type: ACTIVE_COMPARATOR

20mg oral propranolol and oxytocin

Intervention Type: DRUG

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

OXYTOCIN ONLY GROUP

Participants had outright augmentation or induction of labor with oxytocin only

Group Type: PLACEBO_COMPARATOR

Oxytocin only

Intervention Type: DRUG

Participants will have outright augmentation or induction of labor with oxytocin

Interventions

20mg oral propranolol and oxytocin

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

Intervention Type: DRUG

Oxytocin only

Participants will have outright augmentation or induction of labor with oxytocin

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Darlington-Peter Chibuzor Ugoji

OTHER

Sponsor Role: lead

Responsible Party

Darlington-Peter Chibuzor Ugoji

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

UGOJI DR DARLINGTON-PETER, PART 1

Role: PRINCIPAL_INVESTIGATOR

ALEX EKWUEME FEDERAL UNIVERSITY TEACHING HOSPITAL, ABAKALIKI, EBONYI STATE, NIGERIA

Locations

AEFUTHA

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

References

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.

Reference Type: BACKGROUND

PMID: 16625009 (View on PubMed)

Other Identifiers

FETHA/REC/VOL2/2019/277

Identifier Type: -

Identifier Source: org_study_id