Labor, PrematureVagProNCT01206998
Vaginal Progesterone as a Treatment for Women Active Preterm Labor
A study testing Vaginal progesterone gel in people with Labor, Premature, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor, Premature
- What is being tested?
- Vaginal progesterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2010
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Singleton gestation
- Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric estimate
- Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated with cervical change, either shortening and/or dilation by manual exam.
- Management with standard of care tocolytic therapy (nifedipine)
- Planned delivery at Strong Memorial Hospital or Highland Hospital
Who cannot join
- Cervical dilation more than 4 cm.
- Evidence of rupture of membranes
- Negative fetal fibronectin (if done prior to admission)
- Cervical length greater than 3 cm
- Presence of cervical cerclage
- Major fetal anomaly
Show all 14Show fewer
- Small for gestational age, i.e., fetuses with estimated fetal weight below the 10th percentile by ultrasound
- Evidence of chorioamnionitis (Temperature >100.4oF with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
- Suspected placental abruption or significant hemorrhage
- Category III fetal heart rate pattern
- Presence of co-existing medical conditions, including maternal diabetes and hypertension and seizure disorder
- Use of any progesterone in current pregnancy within 4 weeks of enrollment
- First dose of standard tocolytic therapy more than 6 hours prior to randomization
- Allergies to progesterone and progesterone gel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Progesterone in Patients With Active Preterm Labor
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.
Read the detailed description
Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12.8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor.We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.
- Conditions
- Labor, Premature
- Being tested
- Vaginal progesterone gel, Placebo vaginal gel
- Keywords
- preterm labor, progesterone, tocolysis, cervical length
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesterone gelDrug
Also called Prochieve® 8%/Crinone 8%®
Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)
Placebo vaginal gelDrug
Also called Replens®
Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone gel | Experimental | Not described Receives: Drug: Vaginal progesterone gel |
| Placebo vaginal gel | Placebo comparator | Not described Receives: Drug: Placebo vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to delivery
Measured: Time in days from randomization day to day of end of pregnancy
Secondary outcomes (3)
Cervical length
Measured: within 24 hours of first tocolytic dose and at first week follow up
Delivery prior to 37, 34 and 32 weeks
Measured: after delivery
Number of subsequent hospital admissions for preterm labor
Measured: after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Withdrawal of support of the drug company for drug and placebo
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, PrematureStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Juniper Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Tulin Ozcan MD, University of Rochester
- Investigators
- Tulin Ozcan, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206998
- Sponsor's protocol ID
- VagPro 27515
- Acronym
- VagPro
- Status last verified
- Sep 2012
- First submitted
- 20 Sep 2010
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone in Patients With Active Preterm Labor
- ClinicalTrials.gov ID
- NCT01206998
- Acronym / sponsor ID
- VagPro / VagPro 27515
- Conditions
- Labor, Premature
- Keywords
- preterm labor, progesterone, tocolysis, cervical length
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of support of the drug company for drug and placebo
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Juniper Pharmaceuticals, Inc.
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Sep 2010 (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.
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.
Detailed description
Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last two decades. Approximately 12.8% of births are preterm, however these account for more than 75% of all perinatal morbidity and mortality. Currently prophylactic progesterone administration is the most effective method available for the prevention of recurrent preterm birth. Prior studies have examined the impact of progesterone in women with recurrent preterm birth and cervical shortening. The possible use of progesterone in women experiencing active preterm labor may address the highest risk condition, however, there have not been any clinical trials to date examining this use of vaginal progesterone. Inflammation and decidual hemorrhage are among the proposed mechanisms that appear to be related to preterm labor.We will use a double blinded randomized drug placebo design to study the proposed outcomes in women diagnosed with preterm labor and planned to have standard of care tocolytic therapy. Women will be randomized to daily vaginal progesterone gel or placebo and will be maintained on the drug or placebo until delivery or 36 6/7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone gel | Experimental | Drug: Vaginal progesterone gel |
| Placebo vaginal gel | Placebo comparator | Drug: Placebo vaginal gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Singleton gestation
- Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric estimate
- Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated with cervical change, either shortening and/or dilation by manual exam.
- Management with standard of care tocolytic therapy (nifedipine)
Key exclusion criteria (14 listed)
- Cervical dilation more than 4 cm.
- Evidence of rupture of membranes
- Negative fetal fibronectin (if done prior to admission)
- Cervical length greater than 3 cm
- Presence of cervical cerclage
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 |
|---|---|---|
| Vaginal progesterone gelAlso: Prochieve® 8%/Crinone 8%®Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone) | Drug | Vaginal progesterone gel |
| Placebo vaginal gelAlso: Replens®Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug | Drug | Placebo vaginal gel |
Primary outcome
Latency to delivery
Time frame: Time in days from randomization day to day of end of pregnancy
3 secondary outcomes
Cervical length
Time frame: within 24 hours of first tocolytic dose and at first week follow up
Delivery prior to 37, 34 and 32 weeks
Time frame: after delivery
Number of subsequent hospital admissions for preterm labor
Time frame: after delivery
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 1 Oct 2012.
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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.
Tulin Ozcan, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal progesterone gel in people with Labor, Premature, run by University of Rochester 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 6 inclusion and 14 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 1 Oct 2012. 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. Some participants in this study may receive a placebo. 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?
Latency to delivery (time frame: Time in days from randomization day to day of end of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2012.