PregnancyMAPPRONCT01977079
Procalcitonin and Threatened Premature Delivery
A study testing procalcitonin in people with Pregnancy and Premature Delivery, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Premature Delivery
- What is being tested?
- procalcitonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jul 2016
- 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 year
- Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with a measurement of the crown-rump length
- hospitalization for preterm labor between 24 and 36 weeks of gestation
- Intact membranes,
- not opposed to participate in the study
Who cannot join
- Pregnancy uncertain term (no early ultrasound)
- Pregnancy combining a condition that can interfere with the assays performed,
- Uterine malformation known
- Multiple pregnancy,
- Premature rupture of membranes,
- Chrorio-amnionitis,
Show all 11Show fewer
- Fetal malformation known
- Strapping
- GB> 15000 and CRP> 10 mg / L,
- No affiliation to a social security scheme.
- Woman with a measure of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP.
The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .
- Conditions
- Pregnancy, Premature Delivery
- Being tested
- procalcitonin
- Keywords
- pregnancy, premature birth, procalcitonin
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitoninOther
| Study group | Role | What they receive |
|---|---|---|
| Premature birth | Other | At the end of the study patients will be divided into two groups: "Premature delivery" versus "No premature delivery." Prematurity is defined as a birth before 37.
In each group, the procalcitonin rate be estimated with a confidence interval of 95% and compared from a logistic regression. Receives: Other: procalcitonin |
| Not premature birth | Other | At the end of the study patients will be divided into two groups: "Premature delivery" versus "No premature delivery." Prematurity is defined as a birth before 37.
In each group, the procalcitonin rate be estimated with a confidence interval of 95% and compared from a logistic regression. Receives: Other: procalcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
procalcitonin rate
Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, PH, Principal investigator, Centre hospitalier départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977079
- Sponsor's protocol ID
- CHD061-13
- Acronym
- MAPPRO
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2013
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Ducarme G, Desroys du Roure F, Le Thuaut A, Grange J, Vital M, Dimet J. Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study. BMC Pregnancy Childbirth. 2018 Mar 7;18(1):65. doi: 10.1186/s12884-018-1696-2.
PubMed 29514604
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procalcitonin and Threatened Premature Delivery
- ClinicalTrials.gov ID
- NCT01977079
- Acronym / sponsor ID
- MAPPRO / CHD061-13
- Conditions
- Pregnancy, Premature Delivery
- Keywords
- pregnancy, premature birth, procalcitonin
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 6 Nov 2013 (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.
Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP.
The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature birth | Other | Other: procalcitoninAt the end of the study patients will be divided into two groups: "Premature delivery" versus "No premature delivery." Prematurity is defined as a birth before 37. In each group, the procalcitonin rate be estimated with a confidence interval of 95% and compared from a logistic regression. |
| Not premature birth | Other | Other: procalcitoninAt the end of the study patients will be divided into two groups: "Premature delivery" versus "No premature delivery." Prematurity is defined as a birth before 37. In each group, the procalcitonin rate be estimated with a confidence interval of 95% and compared from a logistic regression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 year
- Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with a measurement of the crown-rump length
- hospitalization for preterm labor between 24 and 36 weeks of gestation
- Intact membranes,
- not opposed to participate in the study
Key exclusion criteria (11 listed)
- Pregnancy uncertain term (no early ultrasound)
- Pregnancy combining a condition that can interfere with the assays performed,
- Uterine malformation known
- Multiple pregnancy,
- Premature rupture of membranes,
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 |
|---|---|---|
| procalcitonin | Other | Not premature birth, Premature birth |
Primary outcome
procalcitonin rate
Time frame: up to 48 hours
Estimate serum procalcitonin according to premature or not in patients hospitalized for preterm labor.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 29514604Ducarme G, Desroys du Roure F, Le Thuaut A, Grange J, Vital M, Dimet J. Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study. BMC Pregnancy Childbirth. 2018 Mar 7;18(1):65. doi: 10.1186/s12884-018-1696-2.
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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.
Guillaume DUCARME, PH principal investigator
Centre hospitalier départemental Vendée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procalcitonin in people with Pregnancy and Premature Delivery, run by Centre Hospitalier Departemental Vendee 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 17 Nov 2025. 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 was stopped early. 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?
procalcitonin rate (time frame: up to 48 hours). 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 NCT01977079, which also lists 1 linked publication.
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 17 Nov 2025.