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
|Condition or disease||Intervention/treatment||Phase|
|Induction of Labor Affected Fetus / Newborn||Drug: Propranolol Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|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.|
|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|
2mg of IV push
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
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
Other Name: saline
- 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.
- 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)
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
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Joanne Stone, MD, MS||Icahn School of Medicine at Mount Sinai|