The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor

NCT02702674 | Unknown Phase 3 DMC

• 1 other identifier: propranolol
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of coadministration of oral propranolol to oxytocin on induction of labor.

Conditions

Poor; Labor

Outcome Measures

Primary Outcomes (1)

• duration of first stage of labour

  duration of first stage of labour in hours

  24 hours

Secondary Outcomes (2)

• rate of cesarean section

  48 hours

• Apgar score

  24 hours

Study Arms (2)

propranolol plus oxytocin

ACTIVE COMPARATOR

121 patients who will receive a capsule containing 20 mg propranolol (propranolol plus oxytocin) administrated orally before beginning induction and repeated after 8 hours if no sufficient uterine contractions reached.

Drug: propranolol; Drug: Oxytocin

placebo plus oxytocin

PLACEBO COMPARATOR

121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.

Drug: placebo; Drug: Oxytocin

Interventions

propranolol DRUG

propranolol 20 mg given before induction of labor

Also known as: indral

propranolol plus oxytocin

placebo DRUG

starch tablet containing no active drug material given before induction of labor

placebo plus oxytocin

Oxytocin DRUG

intravenous infusion of oxytocin

Also known as: syntocinon

placebo plus oxytocin; propranolol plus oxytocin

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Gestational age above 37 weeks.
• Fetal life positive on ultrasound.
• Bishop score \> 5.
• Primiparous women.

You may not qualify if:

• history of uterine surgery
• polyhydramnios
• contraindications to β-adrenergic agents, such as systolic blood pressure less than 100 mmHg or pulse rate less than 60/min and more than 120/min
• history of any known cardiac disease
• mother's pulmonary or metabolic disorders
• fetal distress
• estimated weight of the fetus more than 4 kg by ultrasound of cephalic presentation

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

RECRUITING

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

Central Study Contacts

Amr A Riad, MD

CONTACT

01005347179; amr.riad@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: February 13, 2016
• First Posted: March 9, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

EG (1)