CompletedNot Applicable

Search Elevated Serum Alkaline Phosphatase as a Marker of Prenatal Intervillositis Chronic Histiocytic

France54 participantsStarted 2016-04-16

Plain-language summary

Background : Chronic histiocytic intervillositis is a rare placental disease linked with poor perinatal outcome. In a recent study, a major antenatal increased alkaline phosphatase was suspected in patients affected by chronic histiocytic intervillositis. This increase may correspond to the release of alkaline phosphatase by the syncytiotrophoblaste prejudiced in this pathology. Aim : To confirm the association between high levels of alkaline phosphatase and the occurrence of chronic histiocytic intervillositis.

Who can participate

Age range

18 Years

Sex

FEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient aged 18 years or more * Having signed a free and informed consent * Enjoying a social security scheme Inclusion criteria for cases: * Patient who gave birth at the Lille University Hospital between 2000 and 2009. * Lesion of intervillositis chronic histiocytic (IHC) diagnosed during histological examination of the placenta. * An alkaline phosphatase assay during pregnancy is available and has been achieved at University Hospital of Lille. * Prior information and not opposition of the patient to the secondary use of data collected in medical file. Inclusion criteria for low-risk pregnancy : * No pathological obstetric history, no current pregnancy complications * Followed antenatal clinics at the Lille University Hospital * A gestational age corresponding to one of the cases (pairing ± 1 week) * No chronic intervillositis after pathological examination of the placenta Inclusion criteria for high-risk pregnancy: * Patient hospitalized in the maternal-fetal pathology of the Lille University Hospital Service * Presence of IUGR, Death in Utero or severe preeclampsia with fetal repercussion * A gestational age corresponding to one of the cases (pairing ± 1 week) * No chronic intervillositis after pathological examination of the placenta Exclusion Criteria: * Twin pregnancy * Liver disease in the interrogation * Lack of consent of the patient * Patient not covered by a social security scheme * Patient minor * Patient under guardianship

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
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Questions for the trial coordinator

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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of subjects with alkaline phosphatase levels greater than or equal to 5 times the normal

Timeframe: At the time of inclusion

Trial details

NCT IDNCT02668120

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-04-11

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