Early Placental Insufficiency Screening

Pre-eclampsia Clinical Trial

— BIODOP-T1  

Official title:

Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01348711
• Other study ID #: PHRI/06/FP-BIODOP-T1
• Status: Terminated
• Start date: May 2007
• Est. completion date: May 2011

Study information

• Verified date: May 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 226
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Placental Insufficiency
• Pre-eclampsia

Locations

Country	Name	City	State
France	Hospital of Blois -Service de Gynécologie-Obstétrique	Blois
France	CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique	Nantes
France	Hôpital La Milétrie, CHRU Poitiers	Poitiers
France	Olympe de Gouges Women Health Centre, Bretonneau University Hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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