Induction of Labor Affected Fetus / NewbornPhase 2NCT03348683
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
A Phase 2 study testing Propranolol in people with Induction of Labor Affected Fetus / Newborn, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Propranolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 11 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women undergoing induction of labor
- >37 weeks' gestational age
- Non-anomalous, singleton cephalic presenting fetus.
Who cannot join
- Multiple gestations, known fetal anomalies
- Maternal cardiac or hypertensive disease
- Chronic beta blocker use
- Bronchial asthma
- Maternal or fetal indication for immediate delivery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
Read the detailed description
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.
- Being tested
- Propranolol, Placebo
- Keywords
- Induction, Labor, Propranolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.
PlaceboDrug
Also called saline
After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | 2mg of IV push Receives: Drug: Propranolol |
| Placebo | Placebo comparator | an equivalent quantity in milliliters of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: average of 24 hours
Secondary outcomes (8)
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
Measured: average of 24 hours
Duration of Latent
Time of latent labor defined as <6cm of cervical dilation.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start11 Dec 2017
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, joanne stone, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanne Stone, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348683
- Sponsor's protocol ID
- GCO 17-1441
- Status last verified
- Jan 2020
- First submitted
- 10 Nov 2017
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14132613Moghadam 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.
PubMed 24392402Kashanian 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.
PubMed 18588611Pergialiotis 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.
PubMed 26695642Pruyn 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.
PubMed 573555Sanchez-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.
PubMed 8841209Ikeda 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.
PubMed 6482092Meidahl 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.
PubMed 22815467Omar 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.
PubMed 8985808Palomaki 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.
PubMed 16051416Bigelow 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.
PubMed 33421647
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03348683
- Acronym / sponsor ID
- GCO 17-1441
- Keywords
- Induction, Labor, Propranolol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranolol2mg of IV push |
| Placebo | Placebo comparator | Drug: Placeboan equivalent quantity in milliliters of normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nulliparous women undergoing induction of labor
- >37 weeks' gestational age
- Non-anomalous, singleton cephalic presenting fetus.
Key exclusion criteria (5 listed)
- Multiple gestations, known fetal anomalies
- Maternal cardiac or hypertensive disease
- Chronic beta blocker use
- Bronchial asthma
- Maternal or fetal indication for immediate delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAfter induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol. | Drug | Propranolol |
| PlaceboAlso: salineAfter induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline | Drug | Placebo |
Primary outcome
Time From Beginning of Induction to Delivery
Time frame: 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.
8 secondary outcomes
Number of Participants With Various Mode of Delivery
Time frame: average of 24 hours
Duration of Latent
Time frame: average of 24 hours
Number of Participants With Maternal Morbidity Composite Score = 1
Time frame: average of 24 hours
Number of Participants With Postpartum Hemorrhage
Time frame: 30 minutes from drug administration
Number of Fetus With Heart Rate Decelerations
Time frame: 30 minutes from drug administration
Number of Fetus With Fetal Bradycardia
Time frame: 30 minutes from drug administration
Number of Neonates With Neonatal Outcome Composite Score = 1
Time frame: Day 1
Number of Neonates With Hypoglycemia
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14132613BLACK 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.
- Background: PubMed 24392402Moghadam 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.
- Background: PubMed 18588611Kashanian 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.
- Background: PubMed 26695642Pergialiotis 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.
- Background: PubMed 573555Pruyn 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.
- Background: PubMed 8841209Sanchez-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.
- Background: PubMed 6482092Ikeda 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.
- Background: PubMed 22815467Meidahl 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.
- Background: PubMed 8985808Omar 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.
- Background: PubMed 16051416Palomaki 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.
- Derived from this study: PubMed 33421647Bigelow 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.
- Individual participant dataSharing planned: No
Related trials for Induction of Labor Affected Fetus / Newborn
Active, not recruitingPhase 4
The Stimulation To Induce Mothers Study
Oxytocin, Labor Pain
Recruiting
Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
Induction of Labor Affected Fetus / Newborn
Recruiting
Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)
Induction of Labor Affected Fetus / Newborn
Active, not recruiting
Induction ATAD Catheter and Lower Segment Thickness
Induction of Labor Affected Fetus / Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Stone, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Induction of Labor Affected Fetus / Newborn, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Beginning of Induction to Delivery (time frame: average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03348683, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.