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Stopped at interim analysis
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A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Active Comparator | IV Propranolol - 2mg; one possible repeat dose ≥2 hours later |
|
| Placebo | Placebo Comparator | Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol Hydrochloride | Drug | 2mg/mL vials |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mode of Delivery | Number of participants with a cesarean delivery | From enrollment into the trial until delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Labor | Time in hours from start of labor or induction of labor to delivery | hours from start of labor or induction of labor to time of delivery |
| Postpartum Hemorrhage | Amount of blood loss measured in mL |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Levine, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Pennsylvania Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37290102 | Derived | McCoy JA, Walheim L, McCabe MG, Levine LD. Efficacy of Propranolol to Reduce Cesarean Delivery in Prolonged Labor: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jul 1;142(1):71-79. doi: 10.1097/AOG.0000000000005232. Epub 2023 Jun 7. |
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Post-enrollment exclusion: if patient made cervical change or delivered after enrollment but prior to randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Propranolol | IV Propranolol - 2mg; one possible repeat dose ≥2 hours later Propranolol Hydrochloride: 2mg/mL vials |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
trial stopped by DSMB after interim analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Propranolol | IV Propranolol - 2mg; one possible repeat dose ≥2 hours later Propranolol Hydrochloride: 2mg/mL vials |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mode of Delivery | Number of participants with a cesarean delivery | Intention to treat | Posted | Count of Participants | Participants | From enrollment into the trial until delivery. |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propranolol | IV Propranolol - 2mg; one possible repeat dose ≥2 hours later Propranolol Hydrochloride: 2mg/mL vials |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonataly hypoxic ischemic encephalopathy | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonatal hypoglycemia | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer McCoy | University of Pennsylvania | 215 662 4000 | jennifer.mccoy@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2021 | Aug 1, 2023 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D011273 | Pregnancy, Prolonged |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Saline | Other | 0.9% saline in vials matching the vials of the active drug |
|
| from time of delivery through hospital discharge, usually 2-4 days |
| Chorioamnionitis | Number of participants with chorioamnionitis | from start of labor through delivery |
| Maternal Morbidity | Number of participants with 1 or more of the following: blood transfusion, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, readmission, death | from delivery through 4 weeks postpartum |
| 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 | from delivery through hospital discharge, usually 2-4 days |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Length of Labor | Time in hours from start of labor or induction of labor to delivery | Intention to treat | Posted | Median | Inter-Quartile Range | hours | hours from start of labor or induction of labor to time of delivery |
|
|
|
| Secondary | Postpartum Hemorrhage | Amount of blood loss measured in mL | Intention to treat | Posted | Count of Participants | Participants | from time of delivery through hospital discharge, usually 2-4 days |
|
|
|
| Secondary | Chorioamnionitis | Number of participants with chorioamnionitis | intention to treat | Posted | Count of Participants | Participants | from start of labor through delivery |
|
|
|
| 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 | intention to treat | Posted | Count of Participants | Participants | from delivery through 4 weeks postpartum |
|
|
|
| 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 | intention to treat | Posted | Count of Participants | Participants | from delivery through hospital discharge, usually 2-4 days |
|
|
|
| 0 |
| 84 |
| 3 |
| 84 |
| 46 |
| 84 |
| EG001 | 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 | 0 | 80 | 1 | 80 | 46 | 80 |
| Intensive care unit admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Anaphylaxis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Hysterectomy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal blood transfusion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal intraventricular hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal severe respiratory distress | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Necrotising enterocolitis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Culture proven neonatal sepsis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Endometritis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Venous thromboembolism | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Readmission within 7 days | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| NICU admission >48 hours | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal bradycardia <50 beats per minute within 30 minutes of drug administration | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal hypotension <80/40 mmHg within 30 minutes of drug administration | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal bronchospasm | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal hypoglycemia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Allergic reaction | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |