Pregnancy, ProlongedPhase 3PROPELNCT04299438
Propranolol Rescue of Prolonged Labor
A Phase 3 study testing Propranolol Hydrochloride and Saline in people with Pregnancy, Prolonged, run by Lisa Levine at 2 sites in United States.
Trial summary
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Prolonged
- What is being tested?
- Propranolol Hydrochloride and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2020to 15 Jul 2022
- Phase
- Phase 3
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English-speaking
- >= 36 weeks gestation
- Singleton pregnancy
- Vertex presentation
- No contraindication to a vaginal delivery
- Meets at least one study criteria for prolonged labor:
- cervical dilation <6 cm after ≥8 hours with ruptured membranes and receiving oxytocin OR
- cervical dilation >=6 cm and <1 cm dilation change over ≥2 hours with ruptured membranes and receiving oxytocin
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.
Read the detailed description
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.
- Conditions
- Pregnancy, Prolonged
- Being tested
- Propranolol Hydrochloride, Saline
- Keywords
- Propranolol, Cesarean
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Also called Inderal
2mg/mL vials
SalineOther
0.9% saline in vials matching the vials of the active drug
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Active comparator | IV Propranolol - 2mg; one possible repeat dose ≥2 hours later Receives: Drug: Propranolol Hydrochloride |
| Placebo | Placebo comparator | Normal saline placebo- 2 mL; one possible repeat dose ≥2 hours later Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of Delivery
Number of participants with a cesarean delivery
Measured: From enrollment into the trial until delivery.
Secondary outcomes (5)
Length of Labor
Time in hours from start of labor or induction of labor to delivery
Measured: hours from start of labor or induction of labor to time of delivery
Postpartum Hemorrhage
Amount of blood loss measured in mL
Measured: from time of delivery through hospital discharge, usually 2-4 days
Chorioamnionitis
Number of participants with chorioamnionitis
Measured: 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
Measured: 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
Measured: from delivery through hospital discharge, usually 2-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start14 Jul 2020
- Primary completion15 Jun 2022
- Study completion15 Jul 2022
Why it stopped: Stopped at interim analysis
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 (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, ProlongedStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Levine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Levine, University of Pennsylvania
- Investigators
- Lisa Levine, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299438
- Sponsor's protocol ID
- 834760
- Acronym
- PROPEL
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2020
- Last updated
- 23 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37290102
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propranolol Rescue of Prolonged Labor (PROPEL): A Randomized, Double-blind, Placebo-controlled Multicenter Investigation of Propranolol's Effect on Cesarean Delivery Rate Among Women With Prolonged Labor
- ClinicalTrials.gov ID
- NCT04299438
- Acronym / sponsor ID
- PROPEL / 834760
- Conditions
- Pregnancy, Prolonged
- Keywords
- Propranolol, Cesarean
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped at interim analysis
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Lisa LevineUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Posted 23 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind placebo controlled randomized trial comparing cesarean delivery rates in women given IV propranolol versus placebo for treatment of prolonged labor.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Active comparator | Drug: Propranolol HydrochlorideIV Propranolol - 2mg; one possible repeat dose ≥2 hours later |
| Placebo | Placebo comparator | Other: SalineNormal saline placebo- 2 mL; one possible repeat dose ≥2 hours later |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- English-speaking
- >= 36 weeks gestation
- Singleton pregnancy
- Vertex presentation
- No contraindication to a vaginal delivery
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Propranolol HydrochlorideAlso: Inderal2mg/mL vials | Drug | Propranolol |
| Saline0.9% saline in vials matching the vials of the active drug | Other | Placebo |
Primary outcome
Mode of Delivery
Time frame: From enrollment into the trial until delivery.
Number of participants with a cesarean delivery
5 secondary outcomes
Length of Labor
Time frame: hours from start of labor or induction of labor to time of delivery
Postpartum Hemorrhage
Time frame: from time of delivery through hospital discharge, usually 2-4 days
Chorioamnionitis
Time frame: from start of labor through delivery
Maternal Morbidity
Time frame: from delivery through 4 weeks postpartum
Neonatal Morbidity
Time frame: from delivery through hospital discharge, usually 2-4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37290102McCoy 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.
- Individual participant dataSharing planned: No
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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.
Lisa Levine, MD, MSCE principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propranolol Hydrochloride and Saline in people with Pregnancy, Prolonged, run by Lisa Levine at 2 sites 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Aug 2023). 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?
Mode of Delivery (time frame: From enrollment into the trial until delivery.). 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 NCT04299438, which also lists 1 linked publication.
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 23 Aug 2023.