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

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ClinicalTrials.gov Identifier: NCT03533699
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

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.

Condition or disease Intervention/treatment Phase
Induction of Labor Affected Fetus / Newborn Drug: Propranolol Drug: Placebo Oral Tablet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Investigator)
Masking Description: 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)
Primary Purpose: Treatment
Official Title: A Comparison Between the Effect of Oxytocin Only and Oxytocin Plus Propranolol on Induction of Labor in Term Pregnancy
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propranolol
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
Other Names:
  • beta blocker
  • indral

Placebo Comparator: placebo
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
oral tablets with no active drug




Primary Outcome Measures :
  1. Time from active phase to delivery in minutes [ Time Frame: 16 hours ]
    Time from active phase to delivery in minutes



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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pelvic contraction,
  2. Previous surgical operation on the uterus,
  3. Signs of fetal distress,
  4. Placenta previa
  5. Suspicious macrosomia,
  6. Polyhydramnios,
  7. Hydrocephalus of fetus
  8. History of any known cardiac, pulmonary or metabolic disorder of mother, or maternal drug use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533699


Contacts
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Contact: Amr Riad, MD 01005347179 ext +2 amr.riad@med.asu.edu.eg

Locations
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Egypt
Ain Shams university maternity hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital

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Responsible Party: Amr Ahmed Mahmoud Riad, lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03533699     History of Changes
Other Study ID Numbers: propranolol, labor induction
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propranolol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents