Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients

NCT03348683 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GCO 17-1441
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

Induction; Labor; Propranolol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants With Various Mode of Delivery

  average of 24 hours

• Duration of Latent

  average of 24 hours

• Number of Participants With Maternal Morbidity Composite Score = 1

  average of 24 hours

• Number of Participants With Postpartum Hemorrhage

  30 minutes from drug administration

• Number of Fetus With Heart Rate Decelerations

  30 minutes from drug administration

Study Arms (2)

Propranolol

EXPERIMENTAL

2mg of IV push

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

an equivalent quantity in milliliters of normal saline

Drug: Placebo

Interventions

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.

Propranolol

Placebo DRUG

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

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant patients are the only subjects eligible for study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous women undergoing induction of labor
• \>37 weeks' gestational age
• Non-anomalous, singleton cephalic presenting fetus.

You may not qualify if:

• Multiple gestations, known fetal anomalies
• Maternal cardiac or hypertensive disease
• Chronic beta blocker use
• Bronchial asthma
• Maternal or fetal indication for immediate delivery.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (11)

• BLACK JW, CROWTHER AF, SHANKS RG, SMITH LH, DORNHORST AC. A NEW ADRENERGIC BETARECEPTOR ANTAGONIST. Lancet. 1964 May 16;1(7342):1080-1. doi: 10.1016/s0140-6736(64)91275-9. No abstract available.

  PMID: 14132613 BACKGROUND

• 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.

  PMID: 24392402 BACKGROUND

• 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.

  PMID: 18588611 BACKGROUND

• 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.

  PMID: 26695642 BACKGROUND

• 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. doi: 10.1016/0002-9378(79)90436-8.

  PMID: 573555 BACKGROUND

• 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. doi: 10.1016/0029-7844(96)00223-2.

  PMID: 8841209 BACKGROUND

• 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. doi: 10.1254/jjp.35.319.

  PMID: 6482092 BACKGROUND

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

  PMID: 22815467 BACKGROUND

• 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. doi: 10.1111/j.1540-8167.1996.tb00498.x.

  PMID: 8985808 BACKGROUND

• Palomaki 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. doi: 10.1016/j.ejogrb.2005.06.016. Epub 2005 Jul 26.

  PMID: 16051416 BACKGROUND

• Bigelow CA, Pan S, Overbey JR, Stone J. Propranolol for Induction of Labor in Nulliparas trial a double-blind, randomized, placebo-controlled trial. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100301. doi: 10.1016/j.ajogmf.2020.100301. Epub 2021 Jan 6.

  PMID: 33421647 DERIVED

MeSH Terms

Interventions

Propranolol; Sodium Chloride

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Catherine A Bigelow
• Organization: Icahn School of Medicine at Mount Sinai

cassie.bigelow@gmail.com

651-206-9069

Study Officials

• Joanne Stone, MD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 21, 2017
• Study Start: December 11, 2017
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: January 7, 2020
• Results First Posted: December 26, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)