Pregnancy PretermPARTO-MAPNCT03675061
Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial
A study testing Current care, PartoSure Test negative and PartoSure Test positive in people with Pregnancy Preterm, run by University Hospital, Brest at 1 site in France.
Trial summary
Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Preterm
- What is being tested?
- Current care, PartoSure Test negative and PartoSure Test positive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2018to 23 Feb 2021
- 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
- Major patient
- Pregnant of a singleton
- Followed at Brest hospital and resident unless 30 kms of Hospital
- Patient consultant for preterm delivery threat before 34 weeks of amenorrhea with more than 6 contractions per hour (ie 1 in 10 minutes) felt and / or sensed by external toco-ergometry associated with cervical changes objectified by a measurement of the cervix by ultrasound between 15 and 25 mm
- With capacity of a free and informed consent
- Affiliated member of the French social security system
Who cannot join
- Patient transferred for preterm delivery from a peripheral hospital center
- Patient not followed at Brest hospital
- Patient doesn't lives within 30 km of the Brest hospital
- Clinical premature rupture of membranes
- Circled patients
- Important metrorrhagia
Show all 14Show fewer
- Cervix <15 mm
- Cervical dilatation > 3 cm
- Isolated short cervix defined by a short cervix in measurement of the cervix by ultrasound without uterine contraction felt or captured in external toco-ergometry
- Placenta previa, placenta percreta
- Multiple pregnancy
- Suspicion of chorioamnionitis
- Associated maternal-fetal pathology that may induce prematurity
- No prenatal corticosteroid treatment for this pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work.
Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity.
Read more
The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments.
The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients.
The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days.
However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care.
The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.
- Conditions
- Pregnancy Preterm
- Being tested
- Current care, PartoSure Test negative, PartoSure Test positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current careOther
Tocolysis and a complete corticosteroid treatment.
PartoSure Test negativeDevice
Biochemical test and nifedipine tocolysis, then return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea .
PartoSure Test positiveDevice
Biochemical test and tocolysis and a complete corticosteroid treatment. then if situation is stable, return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Current care : The management of the preterm delivery risk without biochemical test, with hospitalization of the patient, initiation of tocolysis and a complete corticosteroid treatment. Receives: Other: Current care |
| PartoSure group | Other | Each women have a biochemical test = PartoSure Test.
* PartoSure test negative : For a negative test, the patient will be able to benefit from a nifedipine tocolysis, if the uterine contractions require it, then she will return home with a control by a midwife at home twice a week up to 34 weeks of amenorrhea.
* PartoSure test positive : For a positive test, the patient will be hospitalized 7 days with a care identical to the control group. Receives: Device: PartoSure Test negative; Device: PartoSure Test positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the two strategies used for patients with preterm delivery threat and intact membranes
Compare impact of experimental diagnosis strategy (binding usual diagnosis strategy and research of vaginal PAMG-1 with PartoSure® test) with usual diagnosis strategy only, in population of patients with preterm delivery threat and intact membranes, about frequency of appropriate care concerning corticosteroids cure.
Measured: 7 days
Secondary outcomes (7)
Comparison of frequency of prescription of antenatal corticosteroids by following the prescription of patients
Compare frequency of prescription adequacy of antenatal corticosteroids cure appropriate in the 14 days of inclusion between the both diagnosis strategies
Measured: 14 days
diagnosis performances
Assess diagnosis performances (NPV, PPV, Se, Sp) of PartoSure® test in actual clinical situation
Measured: 7 days
Change of care following initial care
Assess care modifications consecutive of initial care by following the numbers of hospitalisation for preterm delivery prediction
Measured: 14 days
Health strategy
Compare the differences of health expenditure cost under experimental strategy and usual strategy
Measured: 14 days
Neonatal morbidity
Compare neonatal morbidity between both group
Measured: An average of 40 weeks
Neonatal mortality
Compare neonatal mortality between both group
Measured: An average of 40 weeks
Level of preterm delivery prediction
Assess in the experimental group the level of preterm delivery prediction in the 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start11 Dec 2018
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy PretermStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675061
- Sponsor's protocol ID
- 29BRC17.0203 - PARTO-MAP
- Acronym
- PARTO-MAP
- Status last verified
- Apr 2021
- First submitted
- 12 Sep 2018
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03675061
- Acronym / sponsor ID
- PARTO-MAP / 29BRC17.0203 - PARTO-MAP
- Conditions
- Pregnancy Preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- 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.
Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work.
Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity.
The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments.
The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients.
The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days.
However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care.
The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Current careCurrent care : The management of the preterm delivery risk without biochemical test, with hospitalization of the patient, initiation of tocolysis and a complete corticosteroid treatment. |
| PartoSure group | Other | Device: PartoSure Test negative, Device: PartoSure Test positiveEach women have a biochemical test = PartoSure Test. * PartoSure test negative : For a negative test, the patient will be able to benefit from a nifedipine tocolysis, if the uterine contractions require it, then she will return home with a control by a midwife at home twice a week up to 34 weeks of amenorrhea. * PartoSure test positive : For a positive test, the patient will be hospitalized 7 days with a care identical to the control group. |
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)
- Major patient
- Pregnant of a singleton
- Followed at Brest hospital and resident unless 30 kms of Hospital
- Patient consultant for preterm delivery threat before 34 weeks of amenorrhea with more than 6 contractions per hour (ie 1 in 10 minutes) felt and / or sensed by external toco-ergometry associated with cervical changes objectified by a measurement of the cervix by ultrasound between 15 and 25 mm
- With capacity of a free and informed consent
Key exclusion criteria (14 listed)
- Patient transferred for preterm delivery from a peripheral hospital center
- Patient not followed at Brest hospital
- Patient doesn't lives within 30 km of the Brest hospital
- Clinical premature rupture of membranes
- Circled patients
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 |
|---|---|---|
| Current careTocolysis and a complete corticosteroid treatment. | Other | Control group |
| PartoSure Test negativeBiochemical test and nifedipine tocolysis, then return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea . | Device | PartoSure group |
| PartoSure Test positiveBiochemical test and tocolysis and a complete corticosteroid treatment. then if situation is stable, return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea | Device | PartoSure group |
Primary outcome
Comparison of the two strategies used for patients with preterm delivery threat and intact membranes
Time frame: 7 days
Compare impact of experimental diagnosis strategy (binding usual diagnosis strategy and research of vaginal PAMG-1 with PartoSure® test) with usual diagnosis strategy only, in population of patients with preterm delivery threat and intact membranes, about frequency of appropriate care concerning corticosteroids cure.
7 secondary outcomes
Comparison of frequency of prescription of antenatal corticosteroids by following the prescription of patients
Time frame: 14 days
diagnosis performances
Time frame: 7 days
Change of care following initial care
Time frame: 14 days
Health strategy
Time frame: 14 days
Neonatal morbidity
Time frame: An average of 40 weeks
Neonatal mortality
Time frame: An average of 40 weeks
Level of preterm delivery prediction
Time frame: 7 days
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 26 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current care, PartoSure Test negative and PartoSure Test positive in people with Pregnancy Preterm, run by University Hospital, Brest at 1 site 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 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: finished, as of the sponsor's last update on 26 Apr 2021. 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 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.
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?
Comparison of the two strategies used for patients with preterm delivery threat and intact membranes (time frame: 7 days). 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 26 Apr 2021.