Propranolol for Protracted Labor

Labor Dystocia Clinical Trial

— PRO-Labor  

Official title:

Propranolol for Prolonged Labor: A Randomized Controlled Trial (PRO-Labor Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741698
• Other study ID #: DDD# 604829
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All cervical ripening will be performed in the labor and delivery unit; continuous fetal heart rate and uterine activity will be monitored in all patients. Cervical dilation is assigned by admitting physicians. Sonography will be performed to document fetal presentation.

At the time of prolonged labor, patients meeting inclusion criteria and no exclusion criteria will be consented. There will be no monetary incentives for participation.

Patients will be randomized to either Propranolol 2mg of IV or expectant management at the time of induction. Maternal vitals will be collected per standard labor management.

Episodes of uterine activity that are deemed excessive by the physician will be treated with a standard combination of maneuvers that included a change in maternal position, oxygen administration, and terbutaline 250 µg subcutaneously. Persistent abnormal fetal heart rate patterns resulted in intervention by removing the patient from the study. Urgent cesarean delivery is defined as a cesarean delivery performed during the ripening process for abnormal fetal heart rate that did not respond to standard maneuvers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2022
• Est. primary completion date: June 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

Exclusion Criteria:

• Preterm gestation

• Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in the neonate

• multiparous women

• Any cardiac condition for which ß 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

• women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage

• Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.

Related Conditions & MeSH terms

• Dystocia
• Labor Dystocia
• Labour;Obstructed

Intervention

Drug:
• Propranolol
Propranolol 2mg IV

Locations

Country	Name	City	State
United States	Christiana Care	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

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 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	cesarean delivery rate	rate of cesarean delivery	At time of delivery
Secondary	maternal length of stay	from time of admission to discharge	From time of admission to time of hospital discharge; an average of two days
Secondary	Maternal Bradycardia event	bradycardia alert during labor	at time of delivery
Secondary	Chorioamnionitis	defined by the presence of maternal fever =100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness	At time of delivery
Secondary	neonatal admission to ICU	NICU admission	At time of delivery
Secondary	Severe respiratory distress syndrome	defined as intubation and mechanical ventilation for a minimum of 12 hours	at time of delivery
Secondary	neonatal sepsis	Culture proven-presumed neonatal sepsis	at time of delivery
Secondary	Neonatal blood transfusion	Neonatal blood transfusion	From time of delivery to time of hospital discharge; up to 6 weeks
Secondary	Hypoxic ischemic encephalopathy	neonatal HIE	through study completion, an average of 1 year