Early Placental Insufficiency Screening

NCT ID: NCT01348711

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-05-31

Brief Summary

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To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation

Detailed Description

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Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.

Uterine artery Doppler during anomaly scan at 12 to 14 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy.

A variety of angiogenic proteins have been studied as potential markers for pre-eclampsia. Among these protein Plgf and sflt-1 have respectively demonstrated higher and lower levels in pregnant women who will subsequently develop pre-eclampsia.

Our study is aimed to evaluate the performance of serum Plgf and sflt-1 measurement in association with uterine artery Doppler as a screening for placental insufficiency.

Conditions

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Pre-eclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Chronic hypertension under medication
* Insulin or not insulin dependant preexisting diabetes
* Previous history of pre-eclampsia
* Previous history of unexplained stillbirth
* Previous history of placental abruption
* Previous history of SGA (\< 10th centile)
* History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister
* History of vascular pathology before 50 years in the father
* Obesity (BMI\>26)
* Nulliparous after 38 years
* Assisted conception with donor
* Primipaternity after 38 years old or before 20 years old

Exclusion Criteria

* Multiple pregnancy
* Pregnancy requiring termination
* Unability to understand the study
* Thrombophilia
* treatment with heparin
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck PERROTIN, MD-PHD

Role: STUDY_DIRECTOR

Univsersity Hospital of TOURS

Locations

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Hospital of Blois -Service de Gynécologie-Obstétrique

Blois, , France

Site Status

CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique

Nantes, , France

Site Status

Hôpital La Milétrie, CHRU Poitiers

Poitiers, , France

Site Status

Olympe de Gouges Women Health Centre, Bretonneau University Hospital

Tours, , France

Site Status

Countries

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France

Other Identifiers

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PHRI/06/FP-BIODOP-T1

Identifier Type: -

Identifier Source: org_study_id

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