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A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
Induction of labor is a common obstetric procedure, which is performed to provoke the onset of labor and lead to delivery of the fetus. While some early studies suggested a possible increased rate of cesarean with induction of labor, more recent meta-analyses have shown that induction does not influence this rate. There is data from small randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for induction of labor. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Experimental | 2mg of IV push |
|
| Placebo | Placebo Comparator | an equivalent quantity in milliliters of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Beginning of Induction to Delivery | The time of induction (based on time of foley balloon placement for cervical ripening or misoprostol administration) to the time of delivery of the infant. | average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Various Mode of Delivery | Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section | average of 24 hours |
| Duration of Latent |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant patients are the only subjects eligible for study
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Stone, MD, MS | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14132613 | Background | BLACK JW, CROWTHER AF, SHANKS RG, SMITH LH, DORNHORST AC. A NEW ADRENERGIC BETARECEPTOR ANTAGONIST. Lancet. 1964 May 16;1(7342):1080-1. doi: 10.1016/s0140-6736(64)91275-9. No abstract available. | |
| 24392402 | Background | Moghadam AD, Jaafarpour M, Khani A. Comparison effect of oral propranolol and oxytocin versus oxytocin only on induction of labour in nulliparous women (a double blind randomized trial). J Clin Diagn Res. 2013 Nov;7(11):2567-9. doi: 10.7860/JCDR/2013/5704.3613. Epub 2013 Nov 10. |
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First enrollment 12-11-2017, final enrollment 12/11/2018. Enrollment occurred on the labor floor of the Mount Sinai Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propranolol | After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push |
| FG001 | Placebo | After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propranolol | After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push |
| BG001 | Placebo | After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Time From Beginning of Induction to Delivery | The time of induction (based on time of foley balloon placement for cervical ripening or misoprostol administration) to the time of delivery of the infant. | N=154 - only those who delivered vaginally | Posted | Mean | Standard Deviation | hours | average of 24 hours |
|
24 hours
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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 | After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of propranolol 2mg of IV push |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fetal bradycardia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Fetal bradycardia within 30 minutes of study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal hypotension | Vascular disorders | Systematic Assessment | Maternal hypotension <80/40 within 30 minutes of study drug (no pressors required) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine A Bigelow | Icahn School of Medicine at Mount Sinai | 651-206-9069 | cassie.bigelow@gmail.com |
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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 | Jun 16, 2017 | Nov 8, 2019 | Prot_SAP_000.pdf |
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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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Study drug and placebo will be randomized and mixed to appear identical by the Mount Sinai Investigational Drug Service (IDS). The randomization code will be kept by the lead pharmacist of the IDS until completion of the trial, at which point data will be unmasked.
| Placebo | Drug | After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline |
|
|
Time of latent labor defined as <6cm of cervical dilation.
| average of 24 hours |
| Number of Participants With Maternal Morbidity Composite Score = 1 | Composite maternal morbidity score consists of a count of postpartum hemorrhage, transfusion, hysterectomy, placental abruption, chorioamnionitis, shoulder dystocia, episiotomy, higher order laceration, and ICU admission. The composite score was computed as a score of 1 for any indication of maternal morbidity, that is the participant experienced at least one maternal morbidity, and the components are given equal weights. Participants who had no evidence of the predefined maternal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1. | average of 24 hours |
| Number of Participants With Postpartum Hemorrhage | Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section | 30 minutes from drug administration |
| Number of Fetus With Heart Rate Decelerations | Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration | 30 minutes from drug administration |
| Number of Fetus With Fetal Bradycardia | Count of fetus with fetal bradycardia (<110bpm for >10 minutes within 30 minutes of study drug administration) | 30 minutes from drug administration |
| Number of Neonates With Neonatal Outcome Composite Score = 1 | Composite neonatal outcome score was for any of the following morbidity: Neonatal Intensive Care Unit (NICU) admission, respiratory support (CPAP, nasal cannula, intubation), culture proven sepsis, radiographically proven intracranial hemorrhage, necrotizing enterocolitis, hypoglycemia (for those infants who had sugar checked), and neonatal death. The composite score was computed as a score of 1 for any indication of neonatal morbidity - neonates who experienced at least one morbidity and the components are given equal weights. Patients who had no evidence of the predefined neonatal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1. | Day 1 |
| Number of Neonates With Hypoglycemia | Neonatal outcome - Number of neonates with hypoglycemia (blood glucose <50). This population includes only the neonates who had heelsticks to check their blood glucose, which is not a universal practice and was not required by the protocol or IRB. The neonates included were those who met the nursery's risk-based protocol to check blood glucose after birth (ex: infants of diabetic mothers, fetal growth restriction, macrosomia, or symptoms suggestive of hypoglycemia) | Day 1 |
| 18588611 | Background | Kashanian M, Fekrat M, Zarrin Z, Ansari NS. A comparison between the effect of oxytocin only and oxytocin plus propranolol on the labor (a double blind randomized trial). J Obstet Gynaecol Res. 2008 Jun;34(3):354-8. doi: 10.1111/j.1447-0756.2008.00790.x. |
| 26695642 | Background | Pergialiotis V, Frountzas M, Prodromidou A, Prapa S, Perrea DN, Vlachos GD. Propranolol and oxytocin versus oxytocin alone for induction and augmentation of labor: a meta-analysis of randomized trials. Arch Gynecol Obstet. 2016 Apr;293(4):721-9. doi: 10.1007/s00404-015-3991-8. Epub 2015 Dec 22. |
| 573555 | Background | Pruyn SC, Phelan JP, Buchanan GC. Long-term propranolol therapy in pregnancy: maternal and fetal outcome. Am J Obstet Gynecol. 1979 Oct 15;135(4):485-9. doi: 10.1016/0002-9378(79)90436-8. |
| 8841209 | Background | Sanchez-Ramos L, Quillen MJ, Kaunitz AM. Randomized trial of oxytocin alone and with propranolol in the management of dysfunctional labor. Obstet Gynecol. 1996 Oct;88(4 Pt 1):517-20. doi: 10.1016/0029-7844(96)00223-2. |
| 6482092 | Background | Ikeda S, Tamaoki H, Akahane M, Nebashi Y. Effects of ritodrine hydrochloride, a beta 2-adrenoceptor stimulant, on uterine motilities in late pregnancy. Jpn J Pharmacol. 1984 Jul;35(3):319-26. doi: 10.1254/jjp.35.319. |
| 22815467 | Background | Meidahl Petersen K, Jimenez-Solem E, Andersen JT, Petersen M, Brodbaek K, Kober L, Torp-Pedersen C, Poulsen HE. beta-Blocker treatment during pregnancy and adverse pregnancy outcomes: a nationwide population-based cohort study. BMJ Open. 2012 Jul 19;2(4):e001185. doi: 10.1136/bmjopen-2012-001185. Print 2012. |
| 8985808 | Background | Omar HA, Rhodes LA, Ramirez R, Arsich J, Einzig S. Alteration of human placental vascular tone by antiarrhythmic medications in vitro. J Cardiovasc Electrophysiol. 1996 Dec;7(12):1197-203. doi: 10.1111/j.1540-8167.1996.tb00498.x. |
| 16051416 | Background | Palomaki O, Uotila J, Tammela O, Kaila T, Lavapuro M, Huhtala H, Tuimala R. A double blind, randomized trial on augmentation of labour with a combination of intravenous propranolol and oxytocin versus oxytocin only. Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):44-9. doi: 10.1016/j.ejogrb.2005.06.016. Epub 2005 Jul 26. |
| 33421647 | Derived | Bigelow CA, Pan S, Overbey JR, Stone J. Propranolol for Induction of Labor in Nulliparas trial a double-blind, randomized, placebo-controlled trial. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100301. doi: 10.1016/j.ajogmf.2020.100301. Epub 2021 Jan 6. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) at admission | Mean | Standard Deviation | kg/m^2 |
|
| Gestational Age (GA) at admission | Median | Inter-Quartile Range | months |
|
| Married | Count of Participants | Participants |
|
| Private Insurance | Count of Participants | Participants |
|
| In vitro Fertilization (IVF) | Count of Participants | Participants |
|
| Fetal Growth Restriction | Count of Participants | Participants |
|
| Tobacco Use | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Various Mode of Delivery | Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section | Posted | Count of Participants | Participants | average of 24 hours |
|
|
|
| Secondary | Duration of Latent | Time of latent labor defined as <6cm of cervical dilation. | Posted | Mean | Standard Deviation | hours | average of 24 hours |
|
|
|
| Secondary | Number of Participants With Maternal Morbidity Composite Score = 1 | Composite maternal morbidity score consists of a count of postpartum hemorrhage, transfusion, hysterectomy, placental abruption, chorioamnionitis, shoulder dystocia, episiotomy, higher order laceration, and ICU admission. The composite score was computed as a score of 1 for any indication of maternal morbidity, that is the participant experienced at least one maternal morbidity, and the components are given equal weights. Participants who had no evidence of the predefined maternal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1. | Posted | Count of Participants | Participants | average of 24 hours |
|
|
|
| Secondary | Number of Participants With Postpartum Hemorrhage | Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section | Posted | Count of Participants | Participants | 30 minutes from drug administration |
|
|
|
| Secondary | Number of Fetus With Heart Rate Decelerations | Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration | Posted | Count of Participants | Participants | 30 minutes from drug administration |
|
|
|
| Secondary | Number of Fetus With Fetal Bradycardia | Count of fetus with fetal bradycardia (<110bpm for >10 minutes within 30 minutes of study drug administration) | Posted | Count of Participants | Participants | 30 minutes from drug administration |
|
|
|
| Secondary | Number of Neonates With Neonatal Outcome Composite Score = 1 | Composite neonatal outcome score was for any of the following morbidity: Neonatal Intensive Care Unit (NICU) admission, respiratory support (CPAP, nasal cannula, intubation), culture proven sepsis, radiographically proven intracranial hemorrhage, necrotizing enterocolitis, hypoglycemia (for those infants who had sugar checked), and neonatal death. The composite score was computed as a score of 1 for any indication of neonatal morbidity - neonates who experienced at least one morbidity and the components are given equal weights. Patients who had no evidence of the predefined neonatal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Number of Neonates With Hypoglycemia | Neonatal outcome - Number of neonates with hypoglycemia (blood glucose <50). This population includes only the neonates who had heelsticks to check their blood glucose, which is not a universal practice and was not required by the protocol or IRB. The neonates included were those who met the nursery's risk-based protocol to check blood glucose after birth (ex: infants of diabetic mothers, fetal growth restriction, macrosomia, or symptoms suggestive of hypoglycemia) | This population includes the neonates who had heelsticks to check their blood glucose. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 121 |
| 1 |
| 121 |
| 16 |
| 121 |
| EG001 | Placebo | After induction was started with Foley or misoprostol placement, 30 minutes passed before administration of an equivalent quantity in milliliters of IV normal saline | 0 | 119 | 0 | 119 | 13 | 119 |
|
|
| Fetal heart rate decelerations | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Fetal heart rate decelerations within 30 minutes of study drug |
|
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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 |
| Forceps assisted vaginal delivery |
|
| Cesarean section |
|