Propranolol for Protracted Labor

NCT04741698 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DDD# 604829
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Induction of labor is one of the most common procedures performed on labor and delivery. In the United States, more than 20 percent of pregnant women undergo an induction of labor \[1\]. There is data from small, randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for labor augmentation. 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 \[2-8\]. Alpha- and beta-adrenergic receptors have been identified in the human myometrium. Propranolol has been shown in studies to enhance uterine contractions and may be a useful tool in this population of women. Therefore, the purpose of this study is to assess whether the administration of propranolol at time of labor dystocia reduces time to delivery.

Conditions

Labour;Obstructed; Labor Dystocia

Outcome Measures

Primary Outcomes (1)

• time to delivery

  The primary outcome is time to delivery (hours) defined as time from initiation of induction method to delivery time, regardless of mode of delivery.

  Number of hours from induction to delivery of neonate; up to 72 hours.

Secondary Outcomes (9)

• cesarean delivery rate

  At time of delivery

• maternal length of stay

  From time of admission to time of hospital discharge; an average of two days

• Maternal Bradycardia event

  at time of delivery

• Chorioamnionitis

  At time of delivery

• neonatal admission to ICU

  At time of delivery

Study Arms (2)

Propranolol 2mg IV

ACTIVE COMPARATOR

At the time of labor dystocia, patients randomized to the treatment arm of propranolol will receive a one-time administration of IV 2mg propranolol in pre-mixed syringes prepared by the pharmacy. The propranolol IV administration recommended in clinical practice guidelines is 1 mg IV over 1 minute. Therefore, total administration time will be 2 minutes.

Drug: Propranolol

No intervention

NO INTERVENTION

At the time of labor dystocia, patients randomized to the placebo arm will not receive any intervention

Interventions

Propranolol DRUG

Propranolol 2mg IV

Also known as: Propranolol Hydrochloride, Inderal, Inderal LA, InnoPran XL, Hemangeol

Propranolol 2mg IV

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• full term (≥37 weeks) gestations determined by routine obstetrical guidelines
• singleton gestation in cephalic presentation
• Intact membranes
• Bishop score of ≤6 and cervical dilation ≤2cm

You may not qualify if:

• Preterm gestation
• Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in the neonate
• multiparous women
• Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus bradycardia, and greater than first degree heart block)
• Known hypersensitivity to propranolol
• Maternal bradycardia (HR \<60bpm)
• Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for hypertension control
• Systolic blood pressure \<90 mmHg, or diastolic blood pressure \<50 mmHg
• Receiving other beta blocker
• Moderate or severe asthma: as this is a contraindication to beta blocker use
• Any contraindication to a vaginal delivery
• fetal demise
• Multifetal gestation
• major fetal anomaly
• prior uterine surgery, previous cesarean section

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care

Newark, Delaware, 19718, United States

Location

Related Publications (7)

• 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

• 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

• 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

MeSH Terms

Conditions

Dystocia

Interventions

Propranolol; propranolol CR

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Helen B Gomez, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 5, 2021
• Study Start: July 27, 2021
• Primary Completion: June 11, 2022
• Study Completion: July 1, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)