Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406197
Recruitment Status : Withdrawn (Investigator left organization prior to study initiation)
First Posted : August 1, 2011
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary:
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 or disease Intervention/treatment Phase
Preterm Labor Drug: Experimental: Vaginal progesterone Drug: Experimental: Topical progesterone Drug: Experimental: Intramuscular progesterone Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterine Abdominal Electromyography Measurements Before and After Progesterone Treatments for Preterm Labor
Actual Study Start Date : July 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406197

United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
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


Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix Identifier: NCT01406197     History of Changes
Other Study ID Numbers: IRB#10OB059
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

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

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