Pregnancy, Prolonged
Conditions
Keywords
Propranolol, Cesarean
Brief summary
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.
Detailed description
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in 326 women given IV propranolol (2 mg with one possible repeat dose greater than 2 hours later) versus IV placebo for treatment of prolonged labor.
Interventions
DRUGPropranolol Hydrochloride
2mg/mL vials
OTHERSaline
0.9% saline in vials matching the vials of the active drug
Sponsors
Lisa Levine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
English-speaking \>= 36 weeks gestation Singleton pregnancy Vertex presentation No contraindication to a vaginal delivery Meets at least one study criteria for prolonged labor: 1. cervical dilation \<6 cm after ≥8 hours with ruptured membranes and receiving oxytocin OR 2. cervical dilation \>=6 cm and \<1 cm dilation change over ≥2 hours with ruptured membranes and receiving oxytocin
Exclusion criteria
Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for hypertension control Receiving other beta blocker Maternal heart rate \< 70 beats per minute, systolic blood pressure \<90 mmHg, or diastolic blood pressure \<50 mmHg on two sets of vital signs in the 1 hour prior to study drug administration: given that bradycardia and hypotension are possible side effects of propranolol History of any form of asthma: as this is a contraindication to beta blocker use Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in the neonate Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus bradycardia, and greater than first degree heart block) Known hypersensitivity to propranolol Intrauterine fetal demise since different labor protocols are used in these women Major fetal congenital anomaly since rate of cesarean may be inherently different in these women, unrelated to labor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mode of Delivery | From enrollment into the trial until delivery. | Number of participants with a cesarean delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Labor | hours from start of labor or induction of labor to time of delivery | Time in hours from start of labor or induction of labor to delivery |
| Postpartum Hemorrhage | from time of delivery through hospital discharge, usually 2-4 days | Amount of blood loss measured in mL |
| Chorioamnionitis | from start of labor through delivery | Number of participants with chorioamnionitis |
| Maternal Morbidity | from delivery through 4 weeks postpartum | Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death |
| Neonatal Morbidity | from delivery through hospital discharge, usually 2-4 days | Number of participants with 1 or more of the following: Intensive care nursery admission \>48, blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, neonatal head cooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death |
Countries
United States
Participant flow
Pre-assignment details
Post-enrollment exclusion: if patient made cervical change or delivered after enrollment but prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Propranolol IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials | 84 |
| Placebo Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later
Saline: 0.9% saline in vials matching the vials of the active drug | 80 |
| Total | 164 |
Baseline characteristics
| Characteristic | Propranolol | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 29.3 years | 29.4 years | 30.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 98 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) White | 33 Participants | 56 Participants | 23 Participants |
| Region of Enrollment United States | 84 participants | 164 participants | 80 participants |
| Sex: Female, Male Female | 84 Participants | 164 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 80 |
| other Total, other adverse events | 46 / 84 | 46 / 80 |
| serious Total, serious adverse events | 3 / 84 | 1 / 80 |
Outcome results
Primary
Mode of Delivery
Number of participants with a cesarean delivery
Time frame: From enrollment into the trial until delivery.
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propranolol | Mode of Delivery | 48 Participants |
| Placebo | Mode of Delivery | 46 Participants |
Secondary
Chorioamnionitis
Number of participants with chorioamnionitis
Time frame: from start of labor through delivery
Population: intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propranolol | Chorioamnionitis | 18 Participants |
| Placebo | Chorioamnionitis | 24 Participants |
Secondary
Length of Labor
Time in hours from start of labor or induction of labor to delivery
Time frame: hours from start of labor or induction of labor to time of delivery
Population: Intention to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propranolol | Length of Labor | 26.6 hours |
| Placebo | Length of Labor | 28.4 hours |
Secondary
Maternal Morbidity
Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death
Time frame: from delivery through 4 weeks postpartum
Population: intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propranolol | Maternal Morbidity | 10 Participants |
| Placebo | Maternal Morbidity | 5 Participants |
Secondary
Neonatal Morbidity
Number of participants with 1 or more of the following: Intensive care nursery admission \>48, blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, neonatal head cooling, severe respiratory distress syndrome, necrotizing enterocolitis, sepsis, death
Time frame: from delivery through hospital discharge, usually 2-4 days
Population: intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propranolol | Neonatal Morbidity | 7 Participants |
| Placebo | Neonatal Morbidity | 4 Participants |
Secondary
Postpartum Hemorrhage
Amount of blood loss measured in mL
Time frame: from time of delivery through hospital discharge, usually 2-4 days
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propranolol | Postpartum Hemorrhage | 17 Participants |
| Placebo | Postpartum Hemorrhage | 8 Participants |