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Labour;ObstructedPhase 1PRO-LaborNCT04741698

Propranolol for Protracted Labor

A Phase 1 study testing Propranolol in people with Labour;Obstructed and Labor Dystocia, run by Christiana Care Health Services at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Induction of labor is one of the most common procedures performed on labor and delivery. In the United States, more than 20 percent of pregnant women undergo an induction of labor [1]. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Labour;Obstructed, Labor Dystocia
What is being tested?
Propranolol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
27 Jul 2021to 1 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age
  • full term (≥37 weeks) gestations determined by routine obstetrical guidelines
  • singleton gestation in cephalic presentation
  • Intact membranes
  • Bishop score of ≤6 and cervical dilation ≤2cm

Who cannot join

  • Preterm gestation
  • Diabetes requiring insulin in labor: given the potential risk of neonatal hypoglycemia in the neonate
  • multiparous women
  • Any cardiac condition for which β blockade is contraindicated (cardiogenic shock, sinus bradycardia, and greater than first degree heart block)
  • Known hypersensitivity to propranolol
  • Maternal bradycardia (HR <60bpm)
Show all 17Show fewer
  • Severe preeclampsia: as patients will be receiving magnesium and possibly labetalol for hypertension control
  • Systolic blood pressure <90 mmHg, or diastolic blood pressure <50 mmHg
  • Receiving other beta blocker
  • Moderate or severe asthma: as this is a contraindication to beta blocker use
  • Any contraindication to a vaginal delivery
  • fetal demise
  • Multifetal gestation
  • major fetal anomaly
  • prior uterine surgery, previous cesarean section
  • women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage
  • Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Christiana Care

    Newark, Delaware, 19718

Other trials in United States

About this study

Official title: Propranolol for Prolonged Labor: A Randomized Controlled Trial (PRO-Labor Trial)

Induction of labor is one of the most common procedures performed on labor and delivery. In the United States, more than 20 percent of pregnant women undergo an induction of labor [1].

There is data from small, randomized studies that demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for labor augmentation. 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 [2-8].

Alpha- and beta-adrenergic receptors have been identified in the human myometrium. Propranolol has been shown in studies to enhance uterine contractions and may be a useful tool in this population of women. Therefore, the purpose of this study is to assess whether the administration of propranolol at time of labor dystocia reduces time to delivery.

Read the detailed description

All cervical ripening will be performed in the labor and delivery unit; continuous fetal heart rate and uterine activity will be monitored in all patients. Cervical dilation is assigned by admitting physicians. Sonography will be performed to document fetal presentation.

At the time of prolonged labor, patients meeting inclusion criteria and no exclusion criteria will be consented. There will be no monetary incentives for participation.

Patients will be randomized to either Propranolol 2mg of IV or expectant management at the time of induction. Maternal vitals will be collected per standard labor management.

Episodes of uterine activity that are deemed excessive by the physician will be treated with a standard combination of maneuvers that included a change in maternal position, oxygen administration, and terbutaline 250 µg subcutaneously. Persistent abnormal fetal heart rate patterns resulted in intervention by removing the patient from the study. Urgent cesarean delivery is defined as a cesarean delivery performed during the ripening process for abnormal fetal heart rate that did not respond to standard maneuvers.

Being tested
Propranolol
Medical subject headings
Dystocia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropranololDrug

    Also called Propranolol Hydrochloride, Inderal, Inderal LA, InnoPran XL

    Propranolol 2mg IV

Study groups in NCT04741698
Study groupRoleWhat they receive
Propranolol 2mg IVActive comparatorAt the time of labor dystocia, patients randomized to the treatment arm of propranolol will receive a one-time administration of IV 2mg propranolol in pre-mixed syringes prepared by the pharmacy. The propranolol IV administration recommended in clinical practice guidelines is 1 mg IV over 1 minute. Therefore, total administration time will be 2 minutes.
Receives: Drug: Propranolol
No interventionNo interventionAt the time of labor dystocia, patients randomized to the placebo arm will not receive any intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to delivery

    The primary outcome is time to delivery (hours) defined as time from initiation of induction method to delivery time, regardless of mode of delivery.

    Measured: Number of hours from induction to delivery of neonate; up to 72 hours.

Secondary outcomes (9)

  1. cesarean delivery rate

    rate of cesarean delivery

    Measured: At time of delivery

  2. maternal length of stay

    from time of admission to discharge

    Measured: From time of admission to time of hospital discharge; an average of two days

  3. Maternal Bradycardia event

    bradycardia alert during labor

    Measured: at time of delivery

  4. Chorioamnionitis

    defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness

    Measured: At time of delivery

  5. neonatal admission to ICU

    NICU admission

    Measured: At time of delivery

  6. Severe respiratory distress syndrome

    defined as intubation and mechanical ventilation for a minimum of 12 hours

    Measured: at time of delivery

  7. neonatal sepsis

    Culture proven-presumed neonatal sepsis

    Measured: at time of delivery

  8. Neonatal blood transfusion

    Neonatal blood transfusion

    Measured: From time of delivery to time of hospital discharge; up to 6 weeks

  9. Hypoxic ischemic encephalopathy

    neonatal HIE

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start27 Jul 2021
  3. Primary completion11 Jun 2022
  4. Study completion1 Jul 2022

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04741698
Sponsor's protocol ID
DDD# 604829
Acronym
PRO-Labor
Status last verified
Jul 2022
First submitted
15 Jan 2021
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24392402

  • 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.

    PubMed 18588611

  • 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.

    PubMed 26695642

  • 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.

    PubMed 573555

  • 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.

    PubMed 8841209

  • 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.

    PubMed 22815467

  • 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.

    PubMed 16051416

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Propranolol in people with Labour;Obstructed and Labor Dystocia, run by Christiana Care Health Services 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 5 inclusion and 17 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 28 Jul 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 to delivery (time frame: Number of hours from induction to delivery of neonate; up to 72 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 NCT04741698, which also lists 7 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 28 Jul 2022.

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