Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor
Primary Purpose
Preterm Labor
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Vaginal progesterone
Experimental: Topical progesterone
Experimental: Intramuscular progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor focused on measuring Progesterone, Progestins, Preterm labor, Premature birth, Uterine electromyography, Uterine contractility
Eligibility 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.
Sites / Locations
- St. Joseph's Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Vaginal progesterone
Topical progesterone
Intramuscular progesterone
Arm Description
vaginal 150 mg micronized progesterone cream delivered via a vaginal applicator; dosed daily (Prochieve, Columbia Laboratories)
topical 150 mg micronized progesterone gel applied to abdomen via a novel applicator; dosed daily
injected IM (upper arm or thigh via syringe) 50mg/day micronized progesterone (Watson Pharmaceuticals)
Outcomes
Primary Outcome Measures
Inhibition of uterine electromyographic (EMG) activity by various formulations of progesterone.
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
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.
Full Information
NCT ID
NCT01406197
First Posted
March 31, 2011
Last Updated
October 24, 2022
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
1. Study Identification
Unique Protocol Identification Number
NCT01406197
Brief Title
Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor
Official Title
Uterine Abdominal Electromyography Measurements Before and After Progesterone Treatments for Preterm Labor
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left organization prior to study initiation
Study Start Date
July 2011 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
Progesterone, Progestins, Preterm labor, Premature birth, Uterine electromyography, Uterine contractility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaginal progesterone
Arm Type
Experimental
Arm Description
vaginal 150 mg micronized progesterone cream delivered via a vaginal applicator; dosed daily (Prochieve, Columbia Laboratories)
Arm Title
Topical progesterone
Arm Type
Experimental
Arm Description
topical 150 mg micronized progesterone gel applied to abdomen via a novel applicator; dosed daily
Arm Title
Intramuscular progesterone
Arm Type
Experimental
Arm Description
injected IM (upper arm or thigh via syringe) 50mg/day micronized progesterone (Watson Pharmaceuticals)
Intervention Type
Drug
Intervention Name(s)
Experimental: Vaginal progesterone
Other Intervention Name(s)
Prochieve, Columbia Laboratories
Intervention Description
Vaginal progesterone formulation (150 mg micronized progesterone daily)
Intervention Type
Drug
Intervention Name(s)
Experimental: Topical progesterone
Other Intervention Name(s)
No other name available
Intervention Description
Progesterone will be applied daily (150 mg micronized progesterone)by topical application
Intervention Type
Drug
Intervention Name(s)
Experimental: Intramuscular progesterone
Other Intervention Name(s)
Watson Laboratories
Intervention Description
Preterm labor patients will be injected IM with micronized progesterone (50 mg/day).
Primary Outcome Measure Information:
Title
Inhibition of uterine electromyographic (EMG) activity by various formulations of progesterone.
Description
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.
Time Frame
EMG will be measured at various times including 0 time pretreatment and up to 48 hours after treatments
Secondary Outcome Measure Information:
Title
Effects of progesterone on uterine EMG activity and preterm birth
Description
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.
Time Frame
Various times after treatments up to 16 weeks to determine when the patients deliver
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Balducci, MD
Organizational Affiliation
St. Joseph's Hospital and Medical Center, Phoenix
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Garfield, PhD
Organizational Affiliation
St. Joseph's Hospital and Medical Center, Phoenix
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20452487
Citation
Kuon RJ, Shi SQ, Maul H, Sohn C, Balducci J, Maner WL, Garfield RE. Pharmacologic actions of progestins to inhibit cervical ripening and prevent delivery depend on their properties, the route of administration, and the vehicle. Am J Obstet Gynecol. 2010 May;202(5):455.e1-9. doi: 10.1016/j.ajog.2010.03.025.
Results Reference
background
PubMed Identifier
21241260
Citation
Lucovnik M, Kuon RJ, Chambliss LR, Maner WL, Shi SQ, Shi L, Balducci J, Garfield RE. Use of uterine electromyography to diagnose term and preterm labor. Acta Obstet Gynecol Scand. 2011 Feb;90(2):150-7. doi: 10.1111/j.1600-0412.2010.01031.x. Epub 2010 Dec 7.
Results Reference
background
PubMed Identifier
21497789
Citation
Kuon RJ, Shi SQ, Maul H, Sohn C, Balducci J, Shi L, Garfield RE. A novel optical method to assess cervical changes during pregnancy and use to evaluate the effects of progestins on term and preterm labor. Am J Obstet Gynecol. 2011 Jul;205(1):82.e15-20. doi: 10.1016/j.ajog.2011.02.048. Epub 2011 Feb 23.
Results Reference
background
PubMed Identifier
21472815
Citation
Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
Results Reference
background
PubMed Identifier
18928984
Citation
Ruddock NK, Shi SQ, Jain S, Moore G, Hankins GD, Romero R, Garfield RE. Progesterone, but not 17-alpha-hydroxyprogesterone caproate, inhibits human myometrial contractions. Am J Obstet Gynecol. 2008 Oct;199(4):391.e1-7. doi: 10.1016/j.ajog.2008.06.085.
Results Reference
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Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor
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