Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

January 2, 2020 updated by: joanne stone, Icahn School of Medicine at Mount Sinai

Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
average of 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Various 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
average of 24 hours
Duration of Latent
Time Frame: average of 24 hours
Time of latent labor defined as <6cm of cervical dilation.
average of 24 hours
Number of Participants With Maternal Morbidity Composite Score = 1
Time Frame: average of 24 hours

Composite maternal morbidity score consists of a count of postpartum hemorrhage, transfusion, hysterectomy, placental abruption, chorioamnionitis, shoulder dystocia, episiotomy, higher order laceration, and ICU admission.

The composite score was computed as a score of 1 for any indication of maternal morbidity, that is the participant experienced at least one maternal morbidity, and the components are given equal weights. Participants who had no evidence of the predefined maternal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1.
average of 24 hours
Number of Participants With 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
30 minutes from drug administration
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
30 minutes from 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)
30 minutes from drug administration
Number of Neonates With Neonatal Outcome Composite Score = 1
Time Frame: Day 1

Composite neonatal outcome score was for any of the following morbidity: Neonatal Intensive Care Unit (NICU) admission, respiratory support (CPAP, nasal cannula, intubation), culture proven sepsis, radiographically proven intracranial hemorrhage, necrotizing enterocolitis, hypoglycemia (for those infants who had sugar checked), and neonatal death.

The composite score was computed as a score of 1 for any indication of neonatal morbidity - neonates who experienced at least one morbidity and the components are given equal weights. Patients who had no evidence of the predefined neonatal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1.
Day 1
Number of Neonates With Hypoglycemia
Time Frame: Day 1

Neonatal outcome - Number of neonates with hypoglycemia (blood glucose <50).

This population includes only the neonates who had heelsticks to check their blood glucose, which is not a universal practice and was not required by the protocol or IRB. The neonates included were those who met the nursery's risk-based protocol to check blood glucose after birth (ex: infants of diabetic mothers, fetal growth restriction, macrosomia, or symptoms suggestive of hypoglycemia)
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Joanne Stone, MD, MS, ICAHN School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 11, 2017

Primary Completion (ACTUAL)

December 11, 2018

Study Completion (ACTUAL)

December 11, 2018

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (ACTUAL)

November 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-1441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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