Trial · NCT03348683
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
NCT03348683, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2019-12-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients. Trials, record NCT03348683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03348683
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
- NCT number
- NCT03348683
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 240 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Propranolol, Placebo
- First posted
- 2017-11-21
- Last updated
- 2020-01-07
- Results first posted
- 2019-12-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Beginning of Induction to Delivery | average of 24 hours | 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. |
| Secondary | Number of Participants With Various Mode of Delivery | average of 24 hours | Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section |
| Secondary | Duration of Latent | average of 24 hours | Time of latent labor defined as \<6cm of cervical dilation. |
| Secondary | Number of Participants With Maternal Morbidity Composite Score = 1 | average of 24 hours | 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. |
| Secondary | Number of Participants With Postpartum Hemorrhage | 30 minutes from drug administration | Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section |
| Secondary | Number of Fetus With Heart Rate Decelerations | 30 minutes from drug administration | Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration |
| Secondary | Number of Fetus With Fetal Bradycardia | 30 minutes from drug administration | Count of fetus with fetal bradycardia (\<110bpm for \>10 minutes within 30 minutes of study drug administration) |
| Secondary | Number of Neonates With Neonatal Outcome Composite Score = 1 | Day 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. |
| Secondary | Number of Neonates With Hypoglycemia | Day 1 | 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) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Beginning of Induction to Delivery | average of 24 hours | N=154 - only those who delivered vaginally | hours | MEAN |
| SECONDARY | Number of Participants With Various Mode of Delivery | average of 24 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Latent | average of 24 hours | hours | MEAN | |
| SECONDARY | Number of Participants With Maternal Morbidity Composite Score = 1 | average of 24 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Postpartum Hemorrhage | 30 minutes from drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Fetus With Heart Rate Decelerations | 30 minutes from drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Fetus With Fetal Bradycardia | 30 minutes from drug administration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Neonates With Neonatal Outcome Composite Score = 1 | Day 1 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Neonates With Hypoglycemia | Day 1 | This population includes the neonates who had heelsticks to check their blood glucose. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Beginning of Induction to Delivery | Propranolol | 13.8 | Standard Deviation 5.4 | hours | |
| Time From Beginning of Induction to Delivery | Placebo | 14.3 | Standard Deviation 5.3 | hours | |
| Number of Participants With Various Mode of Delivery | Propranolol | Spontaneous vaginal delivery | 64 | Participants | |
| Number of Participants With Various Mode of Delivery | Placebo | Spontaneous vaginal delivery | 61 | Participants | |
| Number of Participants With Various Mode of Delivery | Propranolol | Vacuum assisted vaginal delivery | 3 | Participants | |
| Number of Participants With Various Mode of Delivery | Placebo | Vacuum assisted vaginal delivery | 10 | Participants | |
| Number of Participants With Various Mode of Delivery | Propranolol | Forceps assisted vaginal delivery | 8 | Participants | |
| Number of Participants With Various Mode of Delivery | Placebo | Forceps assisted vaginal delivery | 8 | Participants | |
| Number of Participants With Various Mode of Delivery | Propranolol | Cesarean section | 46 | Participants | |
| Number of Participants With Various Mode of Delivery | Placebo | Cesarean section | 40 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propranolol | 121 | |
| Overall Study | STARTED | Placebo | 119 | |
| Overall Study | COMPLETED | Propranolol | 121 | |
| Overall Study | COMPLETED | Placebo | 119 | |
| Overall Study | NOT COMPLETED | Propranolol | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Maternal hypotension | Vascular disorders | Propranolol | 1 | 121 | |
| other | Maternal hypotension | Vascular disorders | Placebo | 0 | 119 | |
| other | Fetal heart rate decelerations | Pregnancy, puerperium and perinatal conditions | Propranolol | 15 | 121 | |
| other | Fetal heart rate decelerations | Pregnancy, puerperium and perinatal conditions | Placebo | 13 | 119 | |
| serious | Fetal bradycardia | Pregnancy, puerperium and perinatal conditions | Propranolol | 1 | 121 | |
| serious | Fetal bradycardia | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 119 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Propranolol | 0 | 121 |
| Total, all-cause mortality | Placebo | 0 | 119 |
| Total, other adverse events | Propranolol | 16 | 121 |
| Total, other adverse events | Placebo | 13 | 119 |
| Total, serious adverse events | Propranolol | 1 | 121 |
| Total, serious adverse events | Placebo | 0 | 119 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Propranolol vs Placebo: Number of Fetus With Heart Rate Decelerations | Trial comparisons |
| Propranolol vs Placebo: Number of Neonates With Neonatal Outcome Composite Score = 1 | Trial comparisons |
| Propranolol vs Placebo: Number of Participants With Postpartum Hemorrhage | Trial comparisons |
| Propranolol vs Placebo: Number of Neonates With Hypoglycemia | Trial comparisons |
| Propranolol vs Placebo: Number of Participants With Maternal Morbidity Composite Score = 1 | Trial comparisons |
| Propranolol vs Placebo: Number of Fetus With Fetal Bradycardia | Trial comparisons |
| Propranolol vs Placebo: deaths from any cause | Trial comparisons |
| Propranolol vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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