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Completed

NCT Number: NCT04168606

Study on Retroplacental Hematomas in Finistère

Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. Histological findings in placentas, course of pregnancies, maternal and fetal characteristics will described and compared between cases with and without placental chronic inflammation.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Brest (médecine interne)

Brest, 29609, France

About this study

Identification of cases:

Placental abruption cases will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018.

The women diagnosed with placental abruption will be first identified by interrogation of the Medical Registry Department (MRD) of Brest University Hospital and of five other maternities of our county between January 2013 and December 2018, using the keyword "placental abruption".

Simultaneously, placental abruption cases will be identified from the Pathology department files of Brest University Hospital using a computerized database (ADICAP system).

Cases of placental abruption included in the study will be clinically defined and will not be only diagnosed by histological examination. All cases will be reviewed by an experienced obstetrician in order to confirm the diagnosis.

Duplicates, medical termination of pregnancy, marginal abruption, placenta previa, cases without histological examination of the placenta, histological cases without compatible clinical signs and cases from an unselected maternity will be excluded.

Women identified with placental abruption in the period of study will be sent an information letter explaining the study and its purpose. Women who express their opposition to participate to the study will be excluded.

Clinical parameters:

The following data will be recorded from medical files on a computerized database: baseline maternal characteristics including preconceptional Body Mass Index (BMI), tobacco use, drug use (cocaine, cannabis, buprenorphine) medical history (chronic hypertension, chronic nephropathy, diabetes, cardiovascular disease, autoimmune disease, previous venous thromboembolism), blood and rhesus group, obstetrical history, especially past vasculoplacental disorder and past placental abruption, age at delivery. The following pregnancy characteristics will also be collected: method of conception, medication during pregnancy (in particular aspirin and low molecular-weight heparin (LMWH)), gestational diabetes, premature rupture of membrane, pre-eclampsia (according to the American College of Obstetricians and Gynecologists' definition published in 2013, term at pre-eclampsia diagnosis, term at delivery and method of delivery, postpartum complications including postpartum hemorrhage (defined by a blood loss > 500 ml, whatever the mode of delivery), disseminated intravascular coagulation (DIVC), thromboembolic event after delivery and before hospital discharge, intensive care admission and length of stay.

The following fetal characteristics will be recorded: presence and term at diagnosis of intrauterine growth restriction (IUGR), stillbirth, birthweight and sex of the newborn. IUGR will be defined according to the 2013 French College of Obstetricians and Gynecologists guidelines by an estimated fetal weight below the 10th percentile using locally-accepted curve (AUDIPOG) associated with signs of fetal growth pathological restriction.

Placental parameters:

Histopathological examination of the placentas had been performed by two senior perinatal pathologists at Brest University Hospital. Histological findings were recorded by interrogation of the pathology computerized database APIX V7.

Placentas were fixed in 4% buffered formalin. Standard sampling of three blocks in the central area was performed and slides were Hematoxylin, Eosin and Saffron (HES) stained.

Recorded macroscopic findings will correspond to the following items: placenta weight, fetoplacental weight ratio, placental abruption, abnormal placental set-up (only circumvallation), abnormal umbilical cord (villamentous implantation, thin umbilical cord with < 0,8 cm in diameter, presence of a knot), presence and number of placental infarcts, intervillous thrombi and thrombi in a vessel of the chorionic plate affecting ≥ one third of the placental surface.

Recorded microscopic lesions will correspond to the following items according to Amsterdam consensus: maternal vascular malperfusion lesions such as microscopic infarcts, decidual arteriopathy, abnormal villous maturation (hypermature villi or villous agglutination), presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi, chorangiosis and erythroblastosis, excessive fibrin deposition, chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis, acute inflammation such as acute villitis, acute chorioamniotitis or funiculitis.

Biological parameters:

First trimester Down syndrome screening results will be collected for each pregnancy.

First trimester pregnancy associated plasma protein-A (PAPP-A) and β-human chorionic gonadotrophin (βhCG) levels had been measured in international unit/liter and converted to multiples of the median (MoM) using the crown-rump length or biparietal diameter measurement when the blood sample was obtained as an estimate of gestational age.

Available blood samples collected at the end of first trimester of pregnancy (between 11 weeks of gestation (WG) and 13+6 WG) for Down syndrome screening stored at -20°C in Biochemistry department of Brest University Hospital will be used for Placental Growth Factor (PlGF) quantification. Measurements will be done with the automated B.R.A.H.M.S KRYPTOR compact PLUS system (B.R.A.H.M.S PlGF plus KRYPTOR: Thermo Fisher Scientific, Hennigsdorf, Berlin) according to the manufacturer's instructions described elsewhere. PlGF levels will be expressed in pg/ml.

Informed written consents were obtained from women whose blood samples had been collected at the end of first trimester.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women
  • who had a placental abruption (clinically defined)
  • with an available placental histological examination
  • in one of 5 maternities of our county (Finistère, France)
  • between January 2013 and December 2018.

Exclusion criteria

  • Medical termination of pregnancy
  • marginal abruption
  • placenta previa
  • cases without histological examination of the placenta
  • histological cases without compatible clinical signs
  • cases from an unselected maternity.

Treatment and study plan

Primary outcomes

  1. Histological findings in placentas n°1

    Time frame: through study completion, an average of one year

    placenta weight

  2. Histological findings in placentas n°2

    Time frame: through study completion, an average of one year

    presence of an histologic placental abruption

  3. Histological findings in placentas n°3

    Time frame: through study completion, an average of one year

    presence of an abnormal placental set-up

  4. Histological findings in placentas n°4

    Time frame: through study completion, an average of one year

    presence of an abnormal umbilical cord

  5. Histological findings in placentas n°5

    Time frame: through study completion, an average of one year

    presence of thrombi in the chorionic plate or intervillous thrombi

  6. Histological findings in placentas n°6

    Time frame: through study completion, an average of one year

    presence of maternal vascular malperfusion lesions such as macroscopic or microscopic infarcts, decidual arteriopathy or abnormal villous maturation

  7. Histological findings in placentas n°7

    Time frame: through study completion, an average of one year

    presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi

  8. Histological findings in placentas n°8

    Time frame: through study completion, an average of one year

    presence of chorangiosis or erythroblastosis

  9. Histological findings in placentas n°9

    Time frame: through study completion, an average of one year

    presence of excessive fibrin deposition

  10. Histological findings in placentas n°10

    Time frame: through study completion, an average of one year

    presence of chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis

  11. Histological findings in placentas n°11

    Time frame: through study completion, an average of one year

    presence of acute inflammation such as acute chorioamniotitis or funiculitis

Secondary outcomes

  1. Maternal first trimester biological markers n°1

    Time frame: through study completion, an average of one year

    PAPPA

  2. Maternal first trimester biological markers n°2

    Time frame: through study completion, an average of one year

    Beta HCG

  3. Maternal first trimester biological markers n°3

    Time frame: through study completion, an average of one year

    PlGF

  4. Course of the pregnancies n°1

    Time frame: through study completion, an average of one year

    single or twin pregnancy

  5. Course of the pregnancies n°2

    Time frame: through study completion, an average of one year

    use of aspirin or heparin during pregnancy

  6. Course of the pregnancies n°3

    Time frame: through study completion, an average of one year

    occurrence of pre-eclampsia

  7. Course of the pregnancies n°4

    Time frame: through study completion, an average of one year

    occurrence of IUGR

  8. Course of the pregnancies n°5

    Time frame: through study completion, an average of one year

    occurrence of stillbirth

  9. Course of the pregnancies n°6

    Time frame: through study completion, an average of one year

    occurrence of premature rupture of membrane

  10. Course of the pregnancies n°7

    Time frame: through study completion, an average of one year

    occurrence of gestational diabetes

  11. Course of the pregnancies n°8

    Time frame: through study completion, an average of one year

    term at delivery

  12. Course of the pregnancies n°9

    Time frame: through study completion, an average of one year

    mode of delivery

  13. Course of the pregnancies n°10

    Time frame: through study completion, an average of one year

    occurrence of disseminated intravascular coagulation

  14. Course of the pregnancies n°11

    Time frame: through study completion, an average of one year

    occurrence of postpartum haemorrhage

  15. maternal characteristics n°1

    Time frame: through study completion, an average of one year

    parity

  16. maternal characteristics n°2

    Time frame: through study completion, an average of one year

    previous vasculoplacental disorder

  17. maternal characteristics n°3

    Time frame: through study completion, an average of one year

    BMI before pregnancy

  18. maternal characteristics n°4

    Time frame: through study completion, an average of one year

    age at delivery

  19. maternal characteristics n°5

    Time frame: through study completion, an average of one year

    Tobacco use and drug use

  20. maternal characteristics n°6

    Time frame: through study completion, an average of one year

    chronic hypertension or chronic nephropathy

  21. maternal characteristics n°7

    Time frame: through study completion, an average of one year

    diabetes

  22. maternal characteristics n°8

    Time frame: through study completion, an average of one year

    APL syndrome or SLE

  23. maternal characteristics n°9

    Time frame: through study completion, an average of one year

    previous VTE event

  24. maternal characteristics n°10

    Time frame: through study completion, an average of one year

    blood group

  25. maternal characteristics n°11

    Time frame: through study completion, an average of one year

    mode of conception

  26. fetal characteristics n°1

    Time frame: through study completion, an average of one year

    newborn weight

  27. fetal characteristics n°2

    Time frame: through study completion, an average of one year

    sex

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Retrospective Descriptive Study on Retroplacental Hematomas in Finistère

Acronym: HEMOPLACENTA

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2019
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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