Status:
COMPLETED
Propranolol for Protracted Labor
Lead Sponsor:
Christiana Care Health Services
Conditions:
Labour;Obstructed
Labor Dystocia
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 dat...
Detailed 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 p...
Eligibility Criteria
Inclusion
- ≥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
- 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
- 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.
Key Trial Info
Start Date :
July 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04741698
Start Date
July 27 2021
End Date
July 1 2022
Last Update
July 28 2022
Active Locations (1)
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1
Christiana Care
Newark, Delaware, United States, 19718