Effects of Oral Propranolol on Induction-Delivery Interval During Induction of Labour With Oxytocin

Federal Teaching Hospital Abakaliki

Status: Begins enrollment this month

Conditions: Labour Induction; Propranolol

Treatments: Other: Placebo; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT06960850

AE-FUTHA/REC/VOL3/2024/409

Details and patient eligibility

About

Prolonged pregnancy could lead to perinatal and maternal complications. Oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour. The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin

Full description

Background: Prolonged pregnancy could lead to perinatal and maternal complications. To prevent this, induction of labour becomes necessary. Conventionally, oxytocin has been wildly used for induction of labour, but prolonged labour continued to occur with its attendant sequelae. Propranolol, a non-selective B-adrenergic inhibitor has been found to facilitate labour progress in some studies, by the blockade of the effects of catecholamines on the uterus though there are conflicting reports, with the only meta-analysis inconclusive due to few studies used; hence, the need to further study its role in induction of labour.

Aim: The aim of this study is to assess the role of oral Propranolol in decreasing the induction-delivery with oxytocin.

Methodology: This will be double-blind, superiority randomised controlled trial involving pregnant women at term who meet the inclusion criteria and consent to the study over a six-month period. The participants will be randomised by means of computer-generated numbers from a pool of 308 participants. A set of 154 numbers will receive oxytocin + propranolol once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration; while the other set of 154 numbers would be given oxytocin + placebo once/twice 6 hours apart, starting from 10 minutes before commencement of oxytocin titration.Labour will be monitored with the labour care guide.

Enrollment: 308 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• singleton foetus
• cephalic presentation at term

Exclusion criteria

• Patients on beta blockers
• Contraindications to labour or vaginal delivery
• Multiple gestations
• Preterm labour
• Chorioamnionitis
• Known fetal anomalies
• Bronchial asthma
• Abnormal fetal presentation.
• Antepartum haemorrhage.
• Lung disease
• Previous uterine scar or surgery.
• Foetal heart irregularity

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

308 participants in 2 patient groups, including a placebo group

Propranolol

Experimental group

Description:

A set of 154 numbers will receive oxytocin and propranolol once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Treatment:

Drug: Propranolol

Placebo

Placebo Comparator group

Description:

A set of 154 numbers will receive oxytocin and placebo once or twice 6 hours apart. The first dose will be from 10 minutes before commencement of oxytocin titration and the second dose will be 6 hours from the first dose if delivery has not taken place.

Treatment:

Other: Placebo