A Comparison Between the Effect of Oxytocin Only and Oxytocin Plus Propranolol on Induction of Labor in Term Pregnancy

NCT03533699 | Unknown DMC

• 1 other identifier: propranolol, labor induction
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is conducted to compare the effect of Oral Propranolol and Oxytocin, versus Oxytocin only on induction of labor in term pregnancy.

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• Time from active phase to delivery in minutes

  Time from active phase to delivery in minutes

  16 hours

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

101 women with uncomplicated term pregnancy who will be admitted to the Ain Shams University Maternity hospital and will receive syntocinon intravenous infusion for induction or augmentation of labour.

Drug: Propranolol

placebo

PLACEBO COMPARATOR

101 women with uncomplicated term pregnancy who will be admitted to the Ain Shams University Maternity hospital and will receive syntocinon intravenous infusion for induction or augmentation of labour.

Drug: Placebo Oral Tablet

Interventions

Propranolol DRUG

Also known as: beta blocker, indral

Propranolol

Placebo Oral Tablet DRUG

oral tablets with no active drug

placebo

Eligibility Criteria

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

You may qualify if:

• Gestational age of 38-41 weeks of pregnancy (according to a reliable last menstrual period (LMP) and sonography of first trimester)
• Nulliparity,
• Singleton pregnancy.
• Cephalic presentation.
• Intact membranes.
• Bishop Score 5 or more.

You may not qualify if:

• Pelvic contraction,
• Previous surgical operation on the uterus,
• Signs of fetal distress,
• Placenta previa
• Suspicious macrosomia,
• Polyhydramnios,
• Hydrocephalus of fetus
• History of any known cardiac, pulmonary or metabolic disorder of mother, or maternal drug use.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams university maternity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Propranolol; Adrenergic beta-Antagonists

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Central Study Contacts

Amr Riad, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Then Patients will be randomly assigned to two groups using sealed, sequentially distributed envelopes to which the letters A and B will be allocated. The letter A will be assigned to the propranolol group and the letters B to the oxytocin group. The envelopes, will be opened by the investigator, and according to the letters, the group of patients will be determined. The first vaginal examination will be performed by the investigator, and then the induction will be initiated by the same researcher. Continuation of induction and the control of patients will be monitored by a coworker who knew nothing about the method of initiation of induction, neither did the patients (double blind)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology

Model Details: In the first group (Propranolol plus Oxytocin), a capsule consisting of 20 mg Propranolol will be administered and in the second group (Oxytocin plus placebo), a similar capsule as a placebo will be administrated orally by researcher before beginning of induction of labour. Induction will be initiated at a dose of 2 mIu/min and it will be increased 2 mIu / minute every 15 minutes until good contractions are obtained (3 forceful contractions within 10 minutes) or to a maximum dose of 30 mIu/min; then, it will be continued at this rate for 8 hours. If patients enter the active phase of labour (cervical dilatation = 3-4 cm), induction will be continued until delivery. If no response to induction of labour, a caesarean section will be performed.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 23, 2018
• Study Start: October 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)