Study on Retroplacental Hematomas in Finistère

NCT04168606 | Completed

• 1 other identifier: 29BRC19.0193
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placental Abruption; Placenta Diseases

Keywords

placental abruption

Outcome Measures

Primary Outcomes (11)

• Histological findings in placentas n°1

  placenta weight

  through study completion, an average of one year

• Histological findings in placentas n°2

  presence of an histologic placental abruption

  through study completion, an average of one year

• Histological findings in placentas n°3

  presence of an abnormal placental set-up

  through study completion, an average of one year

• Histological findings in placentas n°4

  presence of an abnormal umbilical cord

  through study completion, an average of one year

• Histological findings in placentas n°5

  presence of thrombi in the chorionic plate or intervillous thrombi

  through study completion, an average of one year

• Histological findings in placentas n°6

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

  through study completion, an average of one year

• Histological findings in placentas n°7

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

  through study completion, an average of one year

• Histological findings in placentas n°8

  presence of chorangiosis or erythroblastosis

  through study completion, an average of one year

• Histological findings in placentas n°9

  presence of excessive fibrin deposition

  through study completion, an average of one year

• Histological findings in placentas n°10

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

  through study completion, an average of one year

• Histological findings in placentas n°11

  presence of acute inflammation such as acute chorioamniotitis or funiculitis

  through study completion, an average of one year

Secondary Outcomes (27)

• Maternal first trimester biological markers n°1

  through study completion, an average of one year

• Maternal first trimester biological markers n°2

  through study completion, an average of one year

• Maternal first trimester biological markers n°3

  through study completion, an average of one year

• Course of the pregnancies n°1

  through study completion, an average of one year

• Course of the pregnancies n°2

  through study completion, an average of one year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest (médecine interne)

Brest, 29609, France

Location

MeSH Terms

Conditions

Abruptio Placentae; Placenta Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 19, 2019
• Study Start: September 23, 2019
• Primary Completion: September 23, 2019
• Study Completion: April 10, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

FR (1)