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CompletedNCT04168606HEMOPLACENTAUpdated Sep 11, 2020

Study on Retroplacental Hematomas in Finistère

An observational study in Placental Abruption and Placenta Diseases, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-11.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
134
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Placental Abruption
  • Placenta Diseases

Keywords

  • placental abruption
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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.

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

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.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
134 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases with placental abruption

    Cases of placental abruption included in our 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.

05

What researchers measure

Primary outcomes

  1. Histological findings in placentas n°1

    placenta weight

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

  2. Histological findings in placentas n°2

    presence of an histologic placental abruption

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

  3. Histological findings in placentas n°3

    presence of an abnormal placental set-up

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

  4. Histological findings in placentas n°4

    presence of an abnormal umbilical cord

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

  5. Histological findings in placentas n°5

    presence of thrombi in the chorionic plate or intervillous thrombi

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

  6. Histological findings in placentas n°6

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

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

  7. Histological findings in placentas n°7

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

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

  8. Histological findings in placentas n°8

    presence of chorangiosis or erythroblastosis

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

  9. Histological findings in placentas n°9

    presence of excessive fibrin deposition

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

  10. Histological findings in placentas n°10

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

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

  11. Histological findings in placentas n°11

    presence of acute inflammation such as acute chorioamniotitis or funiculitis

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

Secondary outcomes

  1. Maternal first trimester biological markers n°1

    PAPPA

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

  2. Maternal first trimester biological markers n°2

    Beta HCG

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

  3. Maternal first trimester biological markers n°3

    PlGF

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

  4. Course of the pregnancies n°1

    single or twin pregnancy

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

  5. Course of the pregnancies n°2

    use of aspirin or heparin during pregnancy

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

  6. Course of the pregnancies n°3

    occurrence of pre-eclampsia

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

  7. Course of the pregnancies n°4

    occurrence of IUGR

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

  8. Course of the pregnancies n°5

    occurrence of stillbirth

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

  9. Course of the pregnancies n°6

    occurrence of premature rupture of membrane

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

  10. Course of the pregnancies n°7

    occurrence of gestational diabetes

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

  11. Course of the pregnancies n°8

    term at delivery

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

  12. Course of the pregnancies n°9

    mode of delivery

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

  13. Course of the pregnancies n°10

    occurrence of disseminated intravascular coagulation

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

  14. Course of the pregnancies n°11

    occurrence of postpartum haemorrhage

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

  15. maternal characteristics n°1

    parity

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

  16. maternal characteristics n°2

    previous vasculoplacental disorder

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

  17. maternal characteristics n°3

    BMI before pregnancy

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

  18. maternal characteristics n°4

    age at delivery

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

  19. maternal characteristics n°5

    Tobacco use and drug use

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

  20. maternal characteristics n°6

    chronic hypertension or chronic nephropathy

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

  21. maternal characteristics n°7

    diabetes

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

  22. maternal characteristics n°8

    APL syndrome or SLE

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

  23. maternal characteristics n°9

    previous VTE event

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

  24. maternal characteristics n°10

    blood group

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

  25. maternal characteristics n°11

    mode of conception

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

  26. fetal characteristics n°1

    newborn weight

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

  27. fetal characteristics n°2

    sex

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

06

Study locations

1 site
  • CHRU de Brest (médecine interne)
    Brest, 29609, France
07

Registry details

Key details

Study ID
NCT04168606
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Sep 23, 2019
Primary completion
Sep 23, 2019
Completion
Apr 10, 2020
Last update
Sep 11, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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