PregnancyPhase 3NCT00809939
17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
A Phase 3 study testing 17 alfa hydroxyprogesterone caproate, natural progesterone and vaginal progesterone in people with Pregnancy, run by Meir Medical Center at 1 site in Israel.
Trial summary
Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- 17 alfa hydroxyprogesterone caproate, natural progesterone and vaginal progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Dec 2012
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
- The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
- A singleton gestation.
Who cannot join
- Multifetal pregnancy.
- The subject has or will have a cervical cerclage in place.
Trial locations and contacts
1 site in 1 country.
About this study
Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.
The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.
- Conditions
- Pregnancy
- Being tested
- 17 alfa hydroxyprogesterone caproate, natural progesterone, vaginal progesterone
- Keywords
- preterm delivery, short cervical length, 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.
17 alfa hydroxyprogesterone caproateDrug
weekly injection of 250 mg until 34 weeks gestation
natural progesteroneDrug
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
17 alfa hydroxyprogesterone caproateDrug
weekly injection, 250 mg until 34 weeks gestation
vaginal progesteroneDrug
daily vaginal progesterone 200 mg until 34 weeks gestation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. Receives: Drug: 17 alfa hydroxyprogesterone caproate |
| 2 | Active comparator | previous preterm delivery, treatment with daily vaginal natural progesterone Receives: Drug: natural progesterone |
| 3 | Active comparator | short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. Receives: Drug: 17 alfa hydroxyprogesterone caproate |
| 4 | Active comparator | short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation. Receives: Drug: vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
Measured: 3 years
Secondary outcomes (1)
comfort of use and consequently of that compliance
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startDec 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tal Biron-Shental, MD, Principal investigator, Meir Medical Center, Israel, Affiliated to Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809939
- Sponsor's protocol ID
- 0129-08-MMC Ver:1
- Status last verified
- Aug 2011
- First submitted
- 16 Dec 2008
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
- ClinicalTrials.gov ID
- NCT00809939
- Acronym / sponsor ID
- 0129-08-MMC Ver:1
- Conditions
- Pregnancy
- Keywords
- preterm delivery, short cervical length, progesterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Dec 2008 (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.
Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.
The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 17 alfa hydroxyprogesterone caproateprevious preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. |
| 2 | Active comparator | Drug: natural progesteroneprevious preterm delivery, treatment with daily vaginal natural progesterone |
| 3 | Active comparator | Drug: 17 alfa hydroxyprogesterone caproateshort cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. |
| 4 | Active comparator | Drug: vaginal progesteroneshort cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
- The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
- A singleton gestation.
Key exclusion criteria (2 listed)
- Multifetal pregnancy.
- The subject has or will have a cervical cerclage in place.
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 |
|---|---|---|
| 17 alfa hydroxyprogesterone caproateweekly injection of 250 mg until 34 weeks gestation | Drug | 1 |
| natural progesteroneprevious preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation. | Drug | 2 |
| 17 alfa hydroxyprogesterone caproateweekly injection, 250 mg until 34 weeks gestation | Drug | 3 |
| vaginal progesteronedaily vaginal progesterone 200 mg until 34 weeks gestation. | Drug | 4 |
Primary outcome
efficacy
Time frame: 3 years
1 secondary outcome
comfort of use and consequently of that compliance
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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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.
Tal Biron-Shental, MD principal investigator
Meir Medical Center, Israel, Affiliated to Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 17 alfa hydroxyprogesterone caproate, natural progesterone and vaginal progesterone in people with Pregnancy, run by Meir Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 30 Aug 2011. 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
efficacy (time frame: 3 years). 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 30 Aug 2011.