Christiana Care
Newark, Delaware, 19718, United States
NCT Number: NCT04741698
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.
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Notify Me18 year and older
Female
Interventional
Phase 1
Newark, Delaware, 19718, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propranolol 2mg IV
Other names: Propranolol Hydrochloride, Inderal, Inderal LA, InnoPran XL, Hemangeol
Time frame: Number of hours from induction to delivery of neonate; up to 72 hours.
The primary outcome is time to delivery (hours) defined as time from initiation of induction method to delivery time, regardless of mode of delivery.
Time frame: At time of delivery
rate of cesarean delivery
Time frame: From time of admission to time of hospital discharge; an average of two days
from time of admission to discharge
Time frame: at time of delivery
bradycardia alert during labor
Time frame: At time of delivery
defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
Time frame: At time of delivery
NICU admission
Time frame: at time of delivery
defined as intubation and mechanical ventilation for a minimum of 12 hours
Time frame: at time of delivery
Culture proven-presumed neonatal sepsis
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Neonatal blood transfusion
Time frame: through study completion, an average of 1 year
neonatal HIE
Christiana Care Health Services
Other
Propranolol for Prolonged Labor: A Randomized Controlled Trial (PRO-Labor Trial)
Acronym: PRO-Labor
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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