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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

Tracking Information
First Submitted Date  ICMJE November 10, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date December 13, 2018
Actual Study Start Date  ICMJE December 11, 2017
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03348683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • 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
  • 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).
  • 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.
  • 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
  • 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
  • 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)
  • 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.
  • Blood glucose level [ Time Frame: Day 1 ]
    Neonatal outcome - Number of neonates with hypoglycemia (blood glucose <50)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
Official Title  ICMJE Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial
Brief Summary A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Induction of Labor Affected Fetus / Newborn
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
    Other Name: saline
Study Arms  ICMJE
  • Experimental: Propranolol
    2mg of IV push
    Intervention: Drug: Propranolol
  • Placebo Comparator: Placebo
    an equivalent quantity in milliliters of normal saline
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 11, 2018
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant patients are the only subjects eligible for study
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03348683
Other Study ID Numbers  ICMJE GCO 17-1441
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party joanne stone, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joanne Stone, MD, MS Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP