Study Stopped
Shortness inclusions of patients
Early Placental Insufficiency Screening
BIODOP-T1
Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population
1 other identifier
observational
226
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedMay 16, 2023
May 1, 2023
3.8 years
February 2, 2010
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence for Pre-eclampsia or SGA
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)
During pregnancy and until 72h after delivery
Secondary Outcomes (2)
Early onset pre-eclampsia
During pregnancy and until 72h after delivery
Severe pre-eclampsia
During pregnancy and until 72h after delivery
Eligibility Criteria
Pregnant between 12 and 14 weeks
You may qualify if:
- 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
You may not qualify if:
- Multiple pregnancy
- Pregnancy requiring termination
- Unability to understand the study
- Thrombophilia
- treatment with heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital of Blois -Service de Gynécologie-Obstétrique
Blois, 41016, France
CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique
Nantes, 44093, France
Hôpital La Milétrie, CHRU Poitiers
Poitiers, 86021, France
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, 37044, France
Biospecimen
SERUM
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Franck PERROTIN, MD-PHD
Univsersity Hospital of TOURS
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2010
First Posted
May 5, 2011
Study Start
May 1, 2007
Primary Completion
February 1, 2011
Study Completion
May 1, 2011
Last Updated
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share