Doppler and Biological Second Trimester Placental Insufficiency Screening (ARTULEP)
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Purpose
To assess the role of uterine artery and maternal serum leptin and lipids and their combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at 20-24 weeks of gestation
| Condition |
|---|
|
Pre-Eclampsia Fetal Growth Retardation Placental Insufficiency |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids |
| Enrollment: | 235 |
| Study Start Date: | May 2003 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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 20 to 24 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. Studies have reported detection rate of 50-70% for a 5% false positive rate in women developing early pre-eclampsia.
A variety of proteins and hormones have been studied as potential markers for pre-eclampsia. Among these protein serum placental leptin has demonstrated higher levels in pregnant women who will subsequently develop pre-eclampsia. However, screening performance of leptin detection in early pregnancy has never been assessed.
Our study is aimed to evaluate the performance of serum leptin measurement in association with uterine artery Doppler as a screening too for placental insufficiency.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
women at increased risk of pre-eclampsia (PE) and intrauterine growth restriction (IUGR)
Inclusion Criteria:
- Chronic hypertension under medication
- Diabetes
- Thrombophilia
- 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
- Obesity (BMI>30)
- Nulliparous after 40 years
- Assisted conception with donor
Exclusion Criteria:
- Multiple pregnancy
- Complicated pregnancy with a high probability of required fetal extraction before term
- Pregnancy requiring termination
- Unability to understand the study
Contacts and Locations| France | |
| Olympe de Gouges Women Health Centre, Bretonneau University Hospital | |
| Tours, France, 37044 | |
| Principal Investigator: | Franck Perrotin, MD-PhD | Tours University Hospital |
More Information
Publications:
| Responsible Party: | Pr Franck Perrotin, CHRU de Tours |
| ClinicalTrials.gov Identifier: | NCT00465634 History of Changes |
| Other Study ID Numbers: | PHRR02-FP/ARTULEP |
| Study First Received: | April 24, 2007 |
| Last Updated: | February 19, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Tours:
|
Screening uterine artery Doppler HELLP syndrome abruption |
Additional relevant MeSH terms:
|
Eclampsia Fetal Growth Retardation Placental Insufficiency Pre-Eclampsia Hypertension, Pregnancy-Induced |
Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Placenta Diseases |
ClinicalTrials.gov processed this record on May 22, 2013