Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Joseph's Hospital and Medical Center, Phoenix
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01406197
First received: March 31, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This study will examine the effects of various formulations of progesterone on uterine electromyographic (EMG) activity in pregnant patients in premature labor to determine if progesterone will suppress uterine electrical activity and which formulation may be best for inhibition of uterine activity. Patients will be monitored prior to treatment and following treatment (every 2 to 4 hours) with one of three different formulations of progesterone for up to two days. Patients will continue to be observed until they deliver. Comparisons will be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24 and 48 hours and times of delivery after treatments (hours or days following treatments). Comparisons between mean values for EMG activity between the various treatments at the various times will also be made.


Condition Intervention
Preterm Labor
Drug: Experimental: Vaginal progesterone
Drug: Experimental: Topical progesterone
Drug: Experimental: Intramuscular progesterone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Uterine Abdominal Electromyography Measurements Before and After Progesterone Treatments for Preterm Labor

Resource links provided by NLM:


Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Inhibition of uterine electromyographic (EMG) activity by various formulations of progesterone. [ Time Frame: EMG will be measured at various times including 0 time pretreatment and up to 48 hours after treatments ] [ Designated as safety issue: No ]
    Uterine electrical activity will be recorded (for 30 minutes at each time point) from the abdominal surface of pregnant patients before (30 minutes before treatment) and following treatment (at 2, 4, 8, 12, 24 and up to 48 hours) with either vehicles or progesterone treatments to evaluate if the treatments reduce EMG activity and therefore may be potential candidates for possible interventions for treating a preterm labor.


Secondary Outcome Measures:
  • Effects of progesterone on uterine EMG activity and preterm birth [ Time Frame: Various times after treatments up to 16 weeks to determine when the patients deliver ] [ Designated as safety issue: No ]
    Secondary measures: Patients will be followed (up to 16 weeks) until delivery by vaginal or Cesarian section to see if any intervention (progesterone treatment) affects timing of birth.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal progesterone
vaginal 150 mg micronized progesterone cream delivered via a vaginal applicator; dosed daily (Prochieve, Columbia Laboratories)
Drug: Experimental: Vaginal progesterone
Vaginal progesterone formulation (150 mg micronized progesterone daily)
Other Name: Prochieve, Columbia Laboratories
Experimental: Topical progesterone
topical 150 mg micronized progesterone gel applied to abdomen via a novel applicator; dosed daily
Drug: Experimental: Topical progesterone
Progesterone will be applied daily (150 mg micronized progesterone)by topical application
Other Name: No other name available
Experimental: Intramuscular progesterone
injected IM (upper arm or thigh via syringe) 50mg/day micronized progesterone (Watson Pharmaceuticals)
Drug: Experimental: Intramuscular progesterone
Preterm labor patients will be injected IM with micronized progesterone (50 mg/day).
Other Name: Watson Laboratories

Detailed Description:

In this study the investigators will compare the effects of vaginal progesterone, intramuscular applied progesterone and topical progesterone on uterine electromyographic activity (EMG)in patients in preterm labor. Electrodes will be placed on the abdominal surface of pregnant patients in preterm labor and the EMG activity recorded for 30 minutes before and following treatments for up to 48 hours. In addition data on delivery times will be recorded when patients delivery vaginally or by Cesarian section. Eligibility criteria: Healthy patients without infection or rupture of membranes with gestational ages between 24 to 34 weeks. Outcome measures: Comparisons of uterine EMG activity (EMG amplitude, frequency, and specific information on EMG bursts) from measurements before treatment to following treatments with progesterone preparations at various times (at 2,4,8, 12,24 and to 48 hours following treatment) and delivery times of patients on various treatments (hours or days following treatments, average delivery times in patients treated by various formulations). Comparisons of mean values in uterine EMG activity (EMG amplitude, burst frequency and frequency of signals in a burst, power spectrum analysis of the bursts and peak power density spectrum of bursts) from before treatment to following treatments at 2 to 24 hours will be compared. Also the time of delivery following treatments will be obtained and the average time of delivery following the various treatments compared.

  Eligibility

Ages Eligible for Study:   17 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy patients in preterm labor between 24 to 34 weeks of gestation presenting to St. Joseph's Hospital and Medical Center.
  • Preterm labor is defined as at least 6 contractions in 60 minutes with a cervix either dilated to 2 centimeters or effaced to 80% and a cervical length measured by ultrasound of less than 3 centimeters, and a positive fetal fibronectin.
  • Maternal ages will be within 17 to 40 year-old range.

Exclusion Criteria:

  • Patients with preterm premature rupture of membranes (PPROM) will be excluded from the study, due to possibility of ascending infection, as will those patients with suspected chorioamnionitis.
  • Patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406197

Contacts
Contact: James Balducci, MD 602-406-3691 James.Balducci@dignityhealth.org
Contact: Robert Garfield, PhD 602-708-7617 robert.garfield@dignityhealth.org

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: James Balducci, MD    602-406-3691    james.balducci@dignityhealth.org   
Contact: Robert Garfield, PhD    602-708-7617    robert.garfield@dignityhealth.org   
Principal Investigator: James Balducci, MD         
Sub-Investigator: Robert Garfield         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
Principal Investigator: James Balducci, MD St. Joseph's Hospital and Medical Center, Phoenix
Principal Investigator: Robert Garfield, PhD St. Joseph's Hospital and Medical Center, Phoenix
  More Information

Publications:

Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01406197     History of Changes
Other Study ID Numbers: IRB#10OB059
Study First Received: March 31, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Progesterone
Progestins
Preterm labor
Premature birth
Uterine electromyography
Uterine contractility

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on October 21, 2014