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Trial record 79 of 288 for:    PROPRANOLOL

Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

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ClinicalTrials.gov Identifier: NCT03348683
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
joanne stone, Icahn School of Medicine at Mount Sinai

Brief Summary:
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.

Condition or disease Intervention/treatment Phase
Induction of Labor Affected Fetus / Newborn Drug: Propranolol Drug: Placebo Phase 2

Detailed Description:
Induction of labor is a common obstetric procedure, which is performed to provoke the onset of labor and lead to delivery of the fetus. While some early studies suggested a possible increased rate of cesarean with induction of labor, more recent meta-analyses have shown that induction does not influence this rate. There is data from small randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for induction of labor. This literature suggests a decrease in the amount of time to delivery and a possible reduction in cesarean section rates when propranolol is used in conjunction with oxytocin for induction of labor compared to oxytocin alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Study drug and placebo will be randomized and mixed to appear identical by the Mount Sinai Investigational Drug Service (IDS). The randomization code will be kept by the lead pharmacist of the IDS until completion of the trial, at which point data will be unmasked.
Primary Purpose: Treatment
Official Title: Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propranolol
2mg of IV push
Drug: Propranolol
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.

Placebo Comparator: Placebo
an equivalent quantity in milliliters of normal saline
Drug: Placebo
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
Other Name: saline




Primary Outcome Measures :
  1. Time from beginning of induction to delivery [ Time Frame: average of 24 hours ]
    The time of induction (based on time of foley balloon placement for cervical ripening or misoprostol administration) to the time of delivery of the infant.


Secondary Outcome Measures :
  1. Mode of Delivery [ Time Frame: average of 24 hours ]
    Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section

  2. Duration of latent versus active labor [ Time Frame: average of 24 hours ]
    Time of latent labor defined as <6cm of cervical dilation. Time of active labor will be defined as >6cm of cervical dilation until full dilation, at which point the second stage of labor will commence (pushing).

  3. Composite score of maternal side effects [ Time Frame: 30 minutes from drug administration ]
    Composite maternal side effects score will consist of count of hypotension <80/40 within 30 minutes of study drug administration, bradycardia <50 bpm within 30 minutes of study drug administration, bronchospasm, allergic reaction (rash, urticaria, angioedema or anaphylaxis). Each component will be given a weighted score to come up with a total composite score.

  4. Postpartum hemorrhage [ Time Frame: 30 minutes from drug administration ]
    Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section

  5. Number of fetus with heart rate decelerations [ Time Frame: 30 minutes from drug administration ]
    Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration

  6. Number of fetus with fetal bradycardia [ Time Frame: 30 minutes from drug administration ]
    Count of fetus with fetal bradycardia (<110bpm for >10 minutes within 30 minutes of study drug administration)

  7. Composite score neonatal outcome [ Time Frame: Day 1 ]
    Composite neonatal outcome score will consist of birth weight, APGAR score - (baby's color, heart rate, reflexes, muscle tone and respiratory effort. APGAR scores range from zero to two for each condition with a maximum final total score of ten.), NICU admission. Each component will be given a weighted score to come up with a total composite score.

  8. Blood glucose level [ Time Frame: Day 1 ]
    Neonatal outcome - Number of neonates with hypoglycemia (blood glucose <50)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant patients are the only subjects eligible for study
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nulliparous women undergoing induction of labor
  • >37 weeks' gestational age
  • Non-anomalous, singleton cephalic presenting fetus.

Exclusion Criteria:

  • Multiple gestations, known fetal anomalies
  • Maternal cardiac or hypertensive disease
  • Chronic beta blocker use
  • Bronchial asthma
  • Maternal or fetal indication for immediate delivery.

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): NCT03348683


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joanne Stone, MD, MS Icahn School of Medicine at Mount Sinai

Publications:

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Responsible Party: joanne stone, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03348683     History of Changes
Other Study ID Numbers: GCO 17-1441
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by joanne stone, Icahn School of Medicine at Mount Sinai:
Induction
Labor
Propranolol

Additional relevant MeSH terms:
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Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents