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Completed

NCT Number: NCT03348683

Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

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

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propranolol

Drug

After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.

Placebo

Drug

After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline

Other names: saline

Primary outcomes

  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 outcomes

  1. 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

  2. Duration of Latent

    Time frame: average of 24 hours

    Time of latent labor defined as <6cm of cervical dilation.

  3. 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.

  4. 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

  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. 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.

  8. 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)

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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