A Study to Evaluate the Use of Placenta Protein 13 (PP13) in the First Trimester of Pregnancy as a Diagnostic Aiding Tool in the Assessment of the Risk for Developing Preeclampsia in Women With Low and Unknown Risk
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Purpose
The purpose of this study is to evaluate whether it is possible to detect changes in the concentration of PP13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. This study will test if the PP13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.
| Condition |
|---|
|
Preeclampsia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Nested Case-Controlled Study Evaluating the Utility of Placental Protein 13 (PP13) In-vitro Diagnostic Kit as a Diagnostic Aiding Tool in Assessment of the Risk for Developing Preeclampsia Necessitating Delivery Before 37 Weeks (Early-preeclampsia) Based on First Trimester Blood Testing of Pregnant Women With Low and Unknown Risk |
- Preeclampsia necessitating delivery at gestational age < 37 weeks including HELLP syndrome and eclampsia [ Time Frame: 37 Weeks ] [ Designated as safety issue: No ]
- Maternal and Neonatal morbidity and mortality and very early preeclampsia necessitating delivery before 34 weeks [ Time Frame: 34 Weeks, At Delivery ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Maternal serum - placental protein 13 level
| Estimated Enrollment: | 2000 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
After obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery Doppler results (if done) will be obtained. Blood for PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and delivery information will be obtained via a chart review for evidence of preeclampsia.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant patients seen or referred to the obstetrical clinic
Inclusion Criteria:
- Healthy, pregnant females
- Singleton fetus at 7 0/7 to 13 6/7 weeks gestation
Exclusion Criteria:
- Multi-fetal pregnancy
- Mental retardation
- Known fetal anomaly or demise
- BMI > 35, serious medical condition
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Carl Weiner, MD, MBA | University of Kansas |
More Information
No publications provided
| Responsible Party: | Carl Weiner, MD, Professor and Chair, Obstetrics and Gynecology, University of Kansas Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT00572793 History of Changes |
| Other Study ID Numbers: | 11063, 11063 |
| Study First Received: | December 11, 2007 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |
ClinicalTrials.gov processed this record on May 23, 2013