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

NCT05251610 | Completed

• 1 other identifier: FETHA/REC/VOL2/2019/277
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Duration of Labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maternal Blood pressure change in mmgh

  Change over 30 minutes

• Fetal heart rate change in seconds

  Change over 30 minutes

Study Arms (2)

PROPRANOLOL GROUP

ACTIVE COMPARATOR

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

Drug: 20mg oral propranolol and oxytocin

OXYTOCIN ONLY GROUP

PLACEBO COMPARATOR

Participants had outright augmentation or induction of labor with oxytocin only

Drug: Oxytocin only

Interventions

20mg oral propranolol and oxytocin DRUG

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

PROPRANOLOL GROUP

Oxytocin only DRUG

Participants will have outright augmentation or induction of labor with oxytocin

OXYTOCIN ONLY GROUP

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Nulliparous women selected for induction or augmentation of labour
• Term pregnancy selected for induction or augmentation of labour
• Normal singleton pregnancies with cephalic presenting foetuses.
• Those who gave their consent.

You may not qualify if:

• Co-existing medical illnesses such as diabetes mellitus, cardiac disease, haemoglobinopathies, renal diseases, hypertensive disease, Bronchial asthma,
• Women currently taking Propranolol or a chronic beta-blocker use
• Contraindications to labour or vaginal delivery
• Multiple gestations
• Preterm labour
• Chorioamnionitis
• Known fetal anomalies
• Abnormal fetal presentation.
• Antepartum haemorrhage.
• Contraindication to induction and augmentation of labour
• Multi-party
• Known allergy to propranolol

Sponsors & Collaborators

• Darlington-Peter Chibuzor Ugoji: lead

Study Sites (1)

AEFUTHA

Abakaliki, Ebonyi State, 234, Nigeria

Location

Related 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. doi: 10.1056/NEJMoa055119.

  PMID: 16625009 BACKGROUND

MeSH Terms

Interventions

Propranolol; Oxytocin

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• UGOJI DR DARLINGTON-PETER, PART 1

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: clinical superiority open-labeled randomized controlled trial

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: February 23, 2022
• Study Start: November 2, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)