Trial Outcomes & Findings for Propranolol Rescue of Prolonged Labor (NCT NCT04299438)
NCT ID: NCT04299438
Last Updated: 2023-08-23
Results Overview
Number of participants with a cesarean delivery
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
164 participants
Primary outcome timeframe
From enrollment into the trial until delivery.
Results posted on
2023-08-23
Participant Flow
Post-enrollment exclusion: if patient made cervical change or delivered after enrollment but prior to randomization
Participant milestones
| Measure |
Propranolol
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
80
|
|
Overall Study
COMPLETED
|
84
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propranolol Rescue of Prolonged Labor
Baseline characteristics by cohort
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.3 years
n=99 Participants
|
30.1 years
n=107 Participants
|
29.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=99 Participants
|
80 participants
n=107 Participants
|
164 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From enrollment into the trial until delivery.Population: Intention to treat
Number of participants with a cesarean delivery
Outcome measures
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
|---|---|---|
|
Mode of Delivery
|
48 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: hours from start of labor or induction of labor to time of deliveryPopulation: Intention to treat
Time in hours from start of labor or induction of labor to delivery
Outcome measures
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
|---|---|---|
|
Length of Labor
|
26.6 hours
Interval 20.6 to 34.3
|
28.4 hours
Interval 24.1 to 32.2
|
SECONDARY outcome
Timeframe: from time of delivery through hospital discharge, usually 2-4 daysPopulation: Intention to treat
Amount of blood loss measured in mL
Outcome measures
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
|---|---|---|
|
Postpartum Hemorrhage
|
17 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: from start of labor through deliveryPopulation: intention to treat
Number of participants with chorioamnionitis
Outcome measures
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
|---|---|---|
|
Chorioamnionitis
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: from delivery through 4 weeks postpartumPopulation: intention to treat
Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death
Outcome measures
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
|---|---|---|
|
Maternal Morbidity
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: from delivery through hospital discharge, usually 2-4 daysPopulation: intention to treat
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
Outcome measures
| Measure |
Propranolol
n=84 Participants
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 Participants
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
|
|---|---|---|
|
Neonatal Morbidity
|
7 Participants
|
4 Participants
|
Adverse Events
Propranolol
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Propranolol
n=84 participants at risk
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Neonataly hypoxic ischemic encephalopathy
|
1.2%
1/84 • Number of events 1 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Intensive care unit admission
|
2.4%
2/84 • Number of events 2 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Maternal death
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Anaphylaxis
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Hysterectomy
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal blood transfusion
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal intraventricular hemorrhage
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal severe respiratory distress
|
0.00%
0/84 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Necrotising enterocolitis
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Culture proven neonatal sepsis
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
Other adverse events
| Measure |
Propranolol
n=84 participants at risk
IV Propranolol - 2mg; one possible repeat dose ≥2 hours later
Propranolol Hydrochloride: 2mg/mL vials
|
Placebo
n=80 participants at risk
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
|
|---|---|---|
|
Endocrine disorders
Neonatal hypoglycemia
|
28.6%
24/84 • Number of events 24 • 30 days
|
25.0%
20/80 • Number of events 20 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Chorioamnionitis
|
21.4%
18/84 • Number of events 18 • 30 days
|
30.0%
24/80 • Number of events 24 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Endometritis
|
0.00%
0/84 • 30 days
|
2.5%
2/80 • Number of events 2 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Venous thromboembolism
|
1.2%
1/84 • Number of events 1 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Readmission within 7 days
|
0.00%
0/84 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
NICU admission >48 hours
|
8.3%
7/84 • Number of events 7 • 30 days
|
5.0%
4/80 • Number of events 4 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Maternal bradycardia <50 beats per minute within 30 minutes of drug administration
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Maternal hypotension <80/40 mmHg within 30 minutes of drug administration
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Maternal bronchospasm
|
0.00%
0/84 • 30 days
|
1.2%
1/80 • Number of events 1 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Maternal hypoglycemia
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
|
Pregnancy, puerperium and perinatal conditions
Allergic reaction
|
0.00%
0/84 • 30 days
|
0.00%
0/80 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place