Propranolol for Protracted Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labour;Obstructed Labor Dystocia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Propranolol 2mg IV

At 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.

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Propranolol 2mg IV

No intervention

At the time of labor dystocia, patients randomized to the placebo arm will not receive any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Propranolol

Propranolol 2mg IV

Intervention Type DRUG

Other Intervention Names

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Propranolol Hydrochloride Inderal Inderal LA InnoPran XL Hemangeol

Eligibility Criteria

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Inclusion Criteria

* ≥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

Exclusion Criteria

* 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)
* 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes