PregnancyNCT00329316
Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent
A study testing Crinone Gel 8% in people with Pregnancy and Premature Birth, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Premature Birth
- What is being tested?
- Crinone Gel 8%
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnancy 24 weeks' gestation Preterm labor in previous pregnancies
- -
Who cannot join
- No medications for PTL or any kind of progesterone.
- Cervical suture
- Multiple pregnancy
About this study
To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent.
- Conditions
- Pregnancy, Premature Birth
- Being tested
- Crinone Gel 8%
- Keywords
- Pre-term labor, progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crinone Gel 8%Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
Why it stopped: Study withdrawn for financial problems. We didnwt get a grant we needed for purchesing the medication for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Investigators
- Yuri Perlitz, MD, Study chair, The Baruch Padeh Medical Center, PoriyaMosheh Ben Ami, Prof., Principal investigator, Head of Obs/Gyn ,The Baruch Padeh Medical center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329316
- Sponsor's protocol ID
- PTL Progesterone Perlitz.CTIL
- Status last verified
- Jun 2007
- First submitted
- 23 May 2006
- Last updated
- 27 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent
- ClinicalTrials.gov ID
- NCT00329316
- Acronym / sponsor ID
- PTL Progesterone Perlitz.CTIL
- Conditions
- Pregnancy, Premature Birth
- Keywords
- Pre-term labor, progesterone
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn for financial problems. We didnwt get a grant we needed for purchesing the medication for the study.
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- First posted
- 24 May 2006 (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.
To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnancy 24 weeks' gestation Preterm labor in previous pregnancies
- -
Key exclusion criteria (3 listed)
- No medications for PTL or any kind of progesterone.
- Cervical suture
- Multiple pregnancy
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 |
|---|---|---|
| Crinone Gel 8% | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Jun 2008.
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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.
Yuri Perlitz, MD study chair
The Baruch Padeh Medical Center, Poriya
Mosheh Ben Ami, Prof. principal investigator
Head of Obs/Gyn ,The Baruch Padeh Medical center, Poriya
Questions about this trial
What is this clinical trial studying?
A study testing Crinone Gel 8% in people with Pregnancy and Premature Birth, run by The Baruch Padeh Medical Center, Poriya.
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 2 inclusion and 3 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 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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 27 Jun 2008.