Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348683
• Other study ID #: GCO 17-1441
• Status: Completed
• Phase: Phase 2
• Start date: December 11, 2017
• Est. completion date: December 11, 2018

Study information

• Verified date: January 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (10)

BLACK JW, CROWTHER AF, SHANKS RG, SMITH LH, DORNHORST AC. A NEW ADRENERGIC BETARECEPTOR ANTAGONIST. Lancet. 1964 May 16;1(7342):1080-1. — View Citation

Ikeda S, Tamaoki H, Akahane M, Nebashi Y. Effects of ritodrine hydrochloride, a beta 2-adrenoceptor stimulant, on uterine motilities in late pregnancy. Jpn J Pharmacol. 1984 Jul;35(3):319-26. — View Citation

Kashanian M, Fekrat M, Zarrin Z, Ansari NS. A comparison between the effect of oxytocin only and oxytocin plus propranolol on the labor (a double blind randomized trial). J Obstet Gynaecol Res. 2008 Jun;34(3):354-8. doi: 10.1111/j.1447-0756.2008.00790.x. — View Citation

Meidahl Petersen K, Jimenez-Solem E, Andersen JT, Petersen M, Brødbæk K, Køber L, Torp-Pedersen C, Poulsen HE. ß-Blocker treatment during pregnancy and adverse pregnancy outcomes: a nationwide population-based cohort study. BMJ Open. 2012 Jul 19;2(4). pii: e001185. doi: 10.1136/bmjopen-2012-001185. Print 2012. — View Citation

Moghadam AD, Jaafarpour M, Khani A. Comparison effect of oral propranolol and oxytocin versus oxytocin only on induction of labour in nulliparous women (a double blind randomized trial). J Clin Diagn Res. 2013 Nov;7(11):2567-9. doi: 10.7860/JCDR/2013/5704.3613. Epub 2013 Nov 10. Erratum in: J Clin Diagn Res. 2015 Aug;9(8):ZZ01. — View Citation

Omar HA, Rhodes LA, Ramirez R, Arsich J, Einzig S. Alteration of human placental vascular tone by antiarrhythmic medications in vitro. J Cardiovasc Electrophysiol. 1996 Dec;7(12):1197-203. — View Citation

Palomäki O, Uotila J, Tammela O, Kaila T, Lavapuro M, Huhtala H, Tuimala R. A double blind, randomized trial on augmentation of labour with a combination of intravenous propranolol and oxytocin versus oxytocin only. Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):44-9. Epub 2005 Jul 26. — View Citation

Pergialiotis V, Frountzas M, Prodromidou A, Prapa S, Perrea DN, Vlachos GD. Propranolol and oxytocin versus oxytocin alone for induction and augmentation of labor: a meta-analysis of randomized trials. Arch Gynecol Obstet. 2016 Apr;293(4):721-9. doi: 10.1007/s00404-015-3991-8. Epub 2015 Dec 22. Review. — View Citation

Pruyn SC, Phelan JP, Buchanan GC. Long-term propranolol therapy in pregnancy: maternal and fetal outcome. Am J Obstet Gynecol. 1979 Oct 15;135(4):485-9. — View Citation

Sanchez-Ramos L, Quillen MJ, Kaunitz AM. Randomized trial of oxytocin alone and with propranolol in the management of dysfunctional labor. Obstet Gynecol. 1996 Oct;88(4 Pt 1):517-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Beginning of Induction to Delivery	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	Number of Participants With Various Mode of Delivery	Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section	average of 24 hours
Secondary	Duration of Latent	Time of latent labor defined as <6cm of cervical dilation.	average of 24 hours
Secondary	Number of Participants With Maternal Morbidity Composite Score = 1	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
Secondary	Number of Participants With Postpartum Hemorrhage	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
Secondary	Number of Fetus With Heart Rate Decelerations	Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration	30 minutes from drug administration
Secondary	Number of Fetus With Fetal Bradycardia	Count of fetus with fetal bradycardia (<110bpm for >10 minutes within 30 minutes of study drug administration)	30 minutes from drug administration
Secondary	Number of Neonates With Neonatal Outcome Composite Score = 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
Secondary	Number of Neonates With Hypoglycemia	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