Preterm LaborNCT01406197
Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor
A study testing Experimental: Vaginal progesterone, Experimental: Topical progesterone and Experimental: Intramuscular progesterone in people with Preterm Labor, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Experimental: Vaginal progesterone, Experimental: Topical progesterone and Experimental: Intramuscular progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2013
- Phase
- Interventional
- 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 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: Uterine Abdominal Electromyography Measurements Before and After Progesterone Treatments for Preterm Labor
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.
Read the 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.
- Conditions
- Preterm Labor
- Being tested
- Experimental: Vaginal progesterone, Experimental: Topical progesterone, Experimental: Intramuscular progesterone
- Keywords
- Progesterone, Progestins, Preterm labor, Premature birth, Uterine electromyography, Uterine contractility
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Vaginal progesteroneDrug
Also called Prochieve, Columbia Laboratories
Vaginal progesterone formulation (150 mg micronized progesterone daily)
Experimental: Topical progesteroneDrug
Also called No other name available
Progesterone will be applied daily (150 mg micronized progesterone)by topical application
Experimental: Intramuscular progesteroneDrug
Also called Watson Laboratories
Preterm labor patients will be injected IM with micronized progesterone (50 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone | Experimental | vaginal 150 mg micronized progesterone cream delivered via a vaginal applicator; dosed daily (Prochieve, Columbia Laboratories) Receives: Drug: Experimental: Vaginal progesterone |
| Topical progesterone | Experimental | topical 150 mg micronized progesterone gel applied to abdomen via a novel applicator; dosed daily Receives: Drug: Experimental: Topical progesterone |
| Intramuscular progesterone | Experimental | injected IM (upper arm or thigh via syringe) 50mg/day micronized progesterone (Watson Pharmaceuticals) Receives: Drug: Experimental: Intramuscular progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: EMG will be measured at various times including 0 time pretreatment and up to 48 hours after treatments
Secondary outcomes (1)
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.
Measured: Various times after treatments up to 16 weeks to determine when the patients deliver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Investigator left organization prior to study initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Balducci, MD, Principal investigator, St. Joseph's Hospital and Medical Center, PhoenixRobert Garfield, PhD, Principal investigator, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406197
- Sponsor's protocol ID
- IRB#10OB059
- Status last verified
- Oct 2022
- First submitted
- 31 Mar 2011
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20452487Lucovnik 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.
PubMed 21241260Kuon 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.
PubMed 21497789Hassan 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.
PubMed 21472815Ruddock 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.
PubMed 18928984
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Abdominal Electromyography Measurements Before and After Progesterone Treatments for Preterm Labor
- ClinicalTrials.gov ID
- NCT01406197
- Acronym / sponsor ID
- IRB#10OB059
- Conditions
- Preterm Labor
- Keywords
- Progesterone, Progestins, Preterm labor, Premature birth, Uterine electromyography, Uterine contractility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left organization prior to study initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone | Experimental | Drug: Experimental: Vaginal progesteronevaginal 150 mg micronized progesterone cream delivered via a vaginal applicator; dosed daily (Prochieve, Columbia Laboratories) |
| Topical progesterone | Experimental | Drug: Experimental: Topical progesteronetopical 150 mg micronized progesterone gel applied to abdomen via a novel applicator; dosed daily |
| Intramuscular progesterone | Experimental | Drug: Experimental: Intramuscular progesteroneinjected IM (upper arm or thigh via syringe) 50mg/day micronized progesterone (Watson Pharmaceuticals) |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Vaginal progesteroneAlso: Prochieve, Columbia LaboratoriesVaginal progesterone formulation (150 mg micronized progesterone daily) | Drug | Vaginal progesterone |
| Experimental: Topical progesteroneAlso: No other name availableProgesterone will be applied daily (150 mg micronized progesterone)by topical application | Drug | Topical progesterone |
| Experimental: Intramuscular progesteroneAlso: Watson LaboratoriesPreterm labor patients will be injected IM with micronized progesterone (50 mg/day). | Drug | Intramuscular progesterone |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 20452487Kuon 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.
- Background: PubMed 21241260Lucovnik 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.
- Background: PubMed 21497789Kuon 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.
- Background: PubMed 21472815Hassan 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.
- Background: PubMed 18928984Ruddock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Balducci, MD principal investigator
St. Joseph's Hospital and Medical Center, Phoenix
Robert Garfield, PhD principal investigator
St. Joseph's Hospital and Medical Center, Phoenix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Vaginal progesterone, Experimental: Topical progesterone and Experimental: Intramuscular progesterone in people with Preterm Labor, run by St. Joseph's Hospital and Medical Center, Phoenix 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 26 Oct 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
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). 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 NCT01406197, which also lists 5 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 26 Oct 2022.