Preterm DeliveryPhase 4NCT00331695
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
A Phase 4 study testing 17 alpha-hydroxyprogesterones caproate in people with Preterm Delivery, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and: either a first… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- 17 alpha-hydroxyprogesterones caproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2006to May 2010
- Phase
- Phase 4
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
- either a first episode of preterm labor stopped by acute tocolysis
- either a history of late miscarriage or premature delivery or uterine malformation or DES;
- either a twin pregnancy.
Who cannot join
- cervical dilatation > 3 cm,
- chorioamnionitis,
- fetal distress,
- placenta praevia,
- abruptio placenta,
- preterm premature rupture of membranes,
Show all 14Show fewer
- polyhydramnios,
- Twin-twin transfusion syndrome,
- IUGR,
- preeclampsia or hypertension,
- other pathology justifying a preterm delivery,
- epilepsy drugs
- participation to another therapeutic trial,
- any patient for whom informed consent cannot be obtained.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHI Poissy st Germain
Poissy, 78303
Chi Poissy St Germain
Poissy, 78
About this study
Official title: Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:
- either a first episode of preterm labor stopped by acute tocolysis;
- either a history of late miscarriage or premature delivery or uterine malformation or DES
- either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.
Read the detailed description
Objective
To demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
- either a first episode of preterm labor stopped by acute tocolysis;
- either a history of late miscarriage or premature delivery or uterine malformation or DES
- either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms.
The maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation.
Arm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group.
IM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group.
Arm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria
- nausea,vomiting,
- weakness
- Conditions
- Preterm Delivery
- Being tested
- 17 alpha-hydroxyprogesterones caproate
- Keywords
- Progesterone, Preterm delivery, Preterm labor, Cervical length, ultrasonography
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17 alpha-hydroxyprogesterones caproateDrug
17 alpha-hydroxyprogesterones caproate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 17 alpha-hydroxyprogesterones caproate Receives: Drug: 17 alpha-hydroxyprogesterones caproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval between inclusion and delivery.
Interval between inclusion and delivery.
Measured: during de study
Secondary outcomes (10)
Preterm delivery rate < 37 W, < 34 W et < 32 W,
Preterm delivery rate < 37 W, < 34 W et < 32 W,
Measured: during the study
Number of hospitalizations for preterm labor,
Number of hospitalizations for preterm labor,
Measured: during the study
Cerclage performed at or after 20 weeks,
Cerclage performed at or after 20 weeks,
Measured: during the study
Neonatal weight,
Neonatal weight,
Measured: during the study
NICU transport
NICU transport
Measured: during the study
Respiratory distress syndrome,
Respiratory distress syndrome,
Measured: during the study
Bronchopulmonary dysplasia,
Bronchopulmonary dysplasia,
Measured: during the study
Necrotizing enterocolitis,
Necrotizing enterocolitis,
Measured: during the study
leucomalacia,
leucomalacia,
Measured: during the study
neonatal death.
neonatal death.
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Patrick ROZENBERG, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331695
- Sponsor's protocol ID
- P040438
- Status last verified
- Mar 2007
- First submitted
- 30 May 2006
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9. doi: 10.1097/01.AOG.0000143254.27255.e9.
PubMed 15516390Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssiere C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.
PubMed 25448515
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
- ClinicalTrials.gov ID
- NCT00331695
- Acronym / sponsor ID
- P040438
- Conditions
- Preterm Delivery
- Keywords
- Progesterone, Preterm delivery, Preterm labor, Cervical length, ultrasonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 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 demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:
- either a first episode of preterm labor stopped by acute tocolysis;
- either a history of late miscarriage or premature delivery or uterine malformation or DES
- either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.
Detailed description
Objective
To demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
- either a first episode of preterm labor stopped by acute tocolysis;
- either a history of late miscarriage or premature delivery or uterine malformation or DES
- either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms.
The maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation.
Arm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group.
IM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group.
Arm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria
- nausea,vomiting,
- weakness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 17 alpha-hydroxyprogesterones caproate17 alpha-hydroxyprogesterones caproate |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:
- either a first episode of preterm labor stopped by acute tocolysis
- either a history of late miscarriage or premature delivery or uterine malformation or DES;
- either a twin pregnancy.
Key exclusion criteria (14 listed)
- cervical dilatation > 3 cm,
- chorioamnionitis,
- fetal distress,
- placenta praevia,
- abruptio placenta,
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 alpha-hydroxyprogesterones caproate17 alpha-hydroxyprogesterones caproate | Drug | 1 |
Primary outcome
Interval between inclusion and delivery.
Time frame: during de study
Interval between inclusion and delivery.
10 secondary outcomes
Preterm delivery rate < 37 W, < 34 W et < 32 W,
Time frame: during the study
Number of hospitalizations for preterm labor,
Time frame: during the study
Cerclage performed at or after 20 weeks,
Time frame: during the study
Neonatal weight,
Time frame: during the study
NICU transport
Time frame: during the study
Respiratory distress syndrome,
Time frame: during the study
Bronchopulmonary dysplasia,
Time frame: during the study
Necrotizing enterocolitis,
Time frame: during the study
leucomalacia,
Time frame: during the study
neonatal death.
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Background: PubMed 15516390Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9. doi: 10.1097/01.AOG.0000143254.27255.e9.
- Derived from this study: PubMed 25448515Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssiere C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.
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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.
Patrick ROZENBERG, MD, principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 17 alpha-hydroxyprogesterones caproate in people with Preterm Delivery, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 4 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: finished, as of the sponsor's last update on 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interval between inclusion and delivery. (time frame: during de study). 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 NCT00331695, which also lists 2 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 9 May 2011.