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Early Placental Insufficiency Screening (BIODOP-T1)

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01348711
First received: February 2, 2010
Last updated: May 4, 2011
Last verified: May 2011
  Purpose

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


Condition
Pre-eclampsia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Occurrence for Pre-eclampsia or SGA [ Time Frame: During pregnancy and until 72h after delivery ] [ Designated as safety issue: No ]
    Pre-eclampsia is defined as hypertension (systolic blood pressure 140mmHg or greater or a diastolic blood pressure 90mmHg or greater on at least 2 occasions 4 hour or 1 week apart) accompanied by proteinuria (more or equal to 0.5g/day or 1 dipstick of ++ or more). SGA is defined as birth weight below the 10th centile for gestational age at birth according to the national birthweight distribution of the french population (INSERM)


Secondary Outcome Measures:
  • Early onset pre-eclampsia [ Time Frame: During pregnancy and until 72h after delivery ] [ Designated as safety issue: No ]
    Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks.

  • Severe pre-eclampsia [ Time Frame: During pregnancy and until 72h after delivery ] [ Designated as safety issue: No ]
    Severe pre-eclampsia is defined as systolic blood pressure of 160mmHg or greater or a diastolic blood pressure of 110mmHg or greater and/or proteinuria greater than 5g in 24 hour collection or occurrence of abruption, eclampsia (seizures during pre-eclampsia), HELLP syndrome (hemolysis, elevated enzyme liver, low platelets), renal insufficiency, fetal demise or birth weight below the 5th centile for gestational age.


Biospecimen Retention:   Samples Without DNA

SERUM


Estimated Enrollment: 300
Study Start Date: May 2007
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant between 12 and 14 weeks

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348711

Locations
France
Hospital of Blois -Service de Gynécologie-Obstétrique
Blois, France, 41016
CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique
Nantes, France, 44093
Hôpital La Milétrie, CHRU Poitiers
Poitiers, France, 86021
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Franck PERROTIN, MD-PHD Univsersity Hospital of TOURS
  More Information

No publications provided

Responsible Party: University Hospital Tours, Direction de la Recherche
ClinicalTrials.gov Identifier: NCT01348711     History of Changes
Other Study ID Numbers: PHRI/06/FP-BIODOP-T1
Study First Received: February 2, 2010
Last Updated: May 4, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Tours:
Pre-eclampsia

Additional relevant MeSH terms:
Eclampsia
Placental Insufficiency
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Placenta Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on November 25, 2014