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

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

Study Overview

• Status: Terminated
• Conditions: Pre-eclampsia

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.

• Study Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• France
  • Blois, France, 41016
    • Hospital of Blois -Service de Gynécologie-Obstétrique
  • Nantes, France, 44093
    • CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique
  • Poitiers, France, 86021
    • Hôpital La Milétrie, CHRU Poitiers
  • Tours, France, 37044
    • Olympe de Gouges Women Health Centre, Bretonneau University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant between 12 and 14 weeks

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early onset pre-eclampsia	Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks.	During pregnancy and until 72h after delivery
Severe pre-eclampsia	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.	During pregnancy and until 72h after delivery

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Study Director: Franck PERROTIN, MD-PHD, Univsersity Hospital of TOURS

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 2, 2010
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pre-eclampsia
• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Placental Insufficiency
• Other Study ID Numbers: PHRI/06/FP-BIODOP-T1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO