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

Duration of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251610
• Other study ID #: FETHA/REC/VOL2/2019/277
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2022
• Source: Alex Ekwueme Federal University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Duration of Labor

Intervention

Drug:
• 20mg oral propranolol and oxytocin
Participants will receive 20mg of oral propranolol 10minutes prior to initiation of augmentation or induction of labor with oxytocin
• Oxytocin only
Participants will have outright augmentation or induction of labor with oxytocin

Locations

Country	Name	City	State
Nigeria	AEFUTHA	Abakaliki	Ebonyi

Sponsors (1)

Lead Sponsor	Collaborator
Darlington-Peter Chibuzor Ugoji

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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