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

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ClinicalTrials.gov Identifier: NCT02702674
Recruitment Status : Unknown
Verified March 2016 by Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment Phase
Poor; Labor Drug: propranolol Drug: placebo Drug: Oxytocin Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: propranolol plus oxytocin
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
propranolol 20 mg given before induction of labor
Other Name: indral

Drug: Oxytocin
intravenous infusion of oxytocin
Other Name: syntocinon

Placebo Comparator: placebo plus oxytocin
121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.
Drug: placebo
starch tablet containing no active drug material given before induction of labor

Drug: Oxytocin
intravenous infusion of oxytocin
Other Name: syntocinon




Primary Outcome Measures :
  1. duration of first stage of labour [ Time Frame: 24 hours ]
    duration of first stage of labour in hours


Secondary Outcome Measures :
  1. rate of cesarean section [ Time Frame: 48 hours ]
    number of participants eventually undergo cesarean section

  2. Apgar score [ Time Frame: 24 hours ]
    Apgar score at minute 1 and minute 5 following delivery



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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Gestational age above 37 weeks.
  2. Fetal life positive on ultrasound.
  3. Bishop score > 5.
  4. Primiparous women.

Exclusion Criteria:

  1. history of uterine surgery
  2. polyhydramnios
  3. 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
  4. history of any known cardiac disease
  5. mother's pulmonary or metabolic disorders
  6. fetal distress
  7. estimated weight of the fetus more than 4 kg by ultrasound of cephalic presentation

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): NCT02702674


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

Locations
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Egypt
Ain Shams 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: NCT02702674     History of Changes
Other Study ID Numbers: propranolol
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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