MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

NCT ID: NCT00763672

Last Updated: 2013-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to determine whether close monitoring of patients with a high sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/ early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality and morbidity and 2/ a simple urinary PlGF screening will be effective.

Detailed Description

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We will measure plasmatic sFlt-1 level between 25 and 28 weeks of gestation and flow velocity of uterine arteries by Doppler (22 - 26 weeks of gestation) in primipara. Patients will be stratified according to the results of the uterine artery Doppler measurement, and then randomized in two groups A and B. In group A, sFlt-1 concentration will be communicated to the obstetrician (+ or -): the threshold of abnormally high plasmatic concentration of sFlt-1 is 957 ng/mL. In patients with a high plasmatic concentration of sFlt-1 (+), the pregnancy will be closely monitored including repeated clinical, biological, and ultrasound examinations. Patients with sFlt-1 plasmatic concentration below 957 ng/mL (-) will be routinely followed-up.In group B, the result of sFlt-1 measurement will not be communicated and the pregnancy will be routinely monitored.Abnormal Doppler recordings in either group will result in a close monitoring as per our usual local practice. Urinary PlGF (expressed as a ratio PlGF/creatininemia) will also be measured and the results will be analyzed at the end of the study. Beside sFlt-1, we will store the plasmatic samples to measure other biomarkers that could be relevant in the future (no DNA analysis will be done without a new patient consent).

Conditions

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Pregnancy Primiparity Hypertension Preeclampsia Intrauterine Growth Retardation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

sFlt-1 status known

Group Type OTHER

Transmission of sFlt-1 results to the investigator

Intervention Type OTHER

Transmission of sFlt-1 results by the laboratory to the investigator

B

sFlt-1 status unknown

Group Type OTHER

No transmission of the sFlt-1 results to the investigator

Intervention Type OTHER

The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.

Interventions

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Transmission of sFlt-1 results to the investigator

Transmission of sFlt-1 results by the laboratory to the investigator

Intervention Type OTHER

No transmission of the sFlt-1 results to the investigator

The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.

Intervention Type OTHER

Other Intervention Names

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Transmission of sFlt-1 No transmission of the sFlt-1

Eligibility Criteria

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Inclusion Criteria

* Pregnant womenAge ≥ 18 years
* Followed in our center before the 28th week of gestation
* Under social security coverage
* Signed informed consent

Exclusion Criteria

* Age \< 18 years
* Followed in our center after the 28th week of gestation
* No social security coverage
* Refusal to be included
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadia BERKANE, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Department of Gynecology Obstetrics and Reproductive Medicine, Hôpital Tenon, AP-HP, UPMC

Paris, , France

Site Status

Countries

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France

References

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Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. doi: 10.1016/S0140-6736(05)17987-2.

Reference Type BACKGROUND
PMID: 15733721 (View on PubMed)

Nagamatsu T, Fujii T, Kusumi M, Zou L, Yamashita T, Osuga Y, Momoeda M, Kozuma S, Taketani Y. Cytotrophoblasts up-regulate soluble fms-like tyrosine kinase-1 expression under reduced oxygen: an implication for the placental vascular development and the pathophysiology of preeclampsia. Endocrinology. 2004 Nov;145(11):4838-45. doi: 10.1210/en.2004-0533. Epub 2004 Jul 29.

Reference Type BACKGROUND
PMID: 15284201 (View on PubMed)

Familoni OB, Adefuye PO, Olunuga TO. Pattern and factors affecting the outcome of pregnancy in hypertensive patients. J Natl Med Assoc. 2004 Dec;96(12):1626-31.

Reference Type BACKGROUND
PMID: 15622693 (View on PubMed)

Maynard SE, Min JY, Merchan J, Lim KH, Li J, Mondal S, Libermann TA, Morgan JP, Sellke FW, Stillman IE, Epstein FH, Sukhatme VP, Karumanchi SA. Excess placental soluble fms-like tyrosine kinase 1 (sFlt1) may contribute to endothelial dysfunction, hypertension, and proteinuria in preeclampsia. J Clin Invest. 2003 Mar;111(5):649-58. doi: 10.1172/JCI17189.

Reference Type BACKGROUND
PMID: 12618519 (View on PubMed)

Sugimoto H, Hamano Y, Charytan D, Cosgrove D, Kieran M, Sudhakar A, Kalluri R. Neutralization of circulating vascular endothelial growth factor (VEGF) by anti-VEGF antibodies and soluble VEGF receptor 1 (sFlt-1) induces proteinuria. J Biol Chem. 2003 Apr 11;278(15):12605-8. doi: 10.1074/jbc.C300012200. Epub 2003 Jan 21.

Reference Type BACKGROUND
PMID: 12538598 (View on PubMed)

Luttun A, Carmeliet P. Soluble VEGF receptor Flt1: the elusive preeclampsia factor discovered? J Clin Invest. 2003 Mar;111(5):600-2. doi: 10.1172/JCI18015. No abstract available.

Reference Type BACKGROUND
PMID: 12618513 (View on PubMed)

Koga K, Osuga Y, Yoshino O, Hirota Y, Ruimeng X, Hirata T, Takeda S, Yano T, Tsutsumi O, Taketani Y. Elevated serum soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) levels in women with preeclampsia. J Clin Endocrinol Metab. 2003 May;88(5):2348-51. doi: 10.1210/jc.2002-021942.

Reference Type BACKGROUND
PMID: 12727995 (View on PubMed)

Romero R, Nien JK, Espinoza J, Todem D, Fu W, Chung H, Kusanovic JP, Gotsch F, Erez O, Mazaki-Tovi S, Gomez R, Edwin S, Chaiworapongsa T, Levine RJ, Karumanchi SA. A longitudinal study of angiogenic (placental growth factor) and anti-angiogenic (soluble endoglin and soluble vascular endothelial growth factor receptor-1) factors in normal pregnancy and patients destined to develop preeclampsia and deliver a small for gestational age neonate. J Matern Fetal Neonatal Med. 2008 Jan;21(1):9-23. doi: 10.1080/14767050701830480.

Reference Type BACKGROUND
PMID: 18175241 (View on PubMed)

Stepan H, Geide A, Faber R. Soluble fms-like tyrosine kinase 1. N Engl J Med. 2004 Nov 18;351(21):2241-2. doi: 10.1056/NEJM200411183512123. No abstract available.

Reference Type BACKGROUND
PMID: 15548791 (View on PubMed)

Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. doi: 10.1056/NEJMoa031884. Epub 2004 Feb 5.

Reference Type BACKGROUND
PMID: 14764923 (View on PubMed)

Hertig A, Berkane N, Lefevre G, Toumi K, Marti HP, Capeau J, Uzan S, Rondeau E. Maternal serum sFlt1 concentration is an early and reliable predictive marker of preeclampsia. Clin Chem. 2004 Sep;50(9):1702-3. doi: 10.1373/clinchem.2004.036715. No abstract available.

Reference Type BACKGROUND
PMID: 15331514 (View on PubMed)

Levine RJ, Thadhani R, Qian C, Lam C, Lim KH, Yu KF, Blink AL, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Urinary placental growth factor and risk of preeclampsia. JAMA. 2005 Jan 5;293(1):77-85. doi: 10.1001/jama.293.1.77.

Reference Type BACKGROUND
PMID: 15632339 (View on PubMed)

Berkane N, Hertig A, Rondeau E, Uzan S. Hypertensive disorders of pregnancy: future perspectives. A French point of view. Curr Opin Obstet Gynecol. 2008 Apr;20(2):107-9. doi: 10.1097/GCO.0b013e3282f73391. No abstract available.

Reference Type BACKGROUND
PMID: 18388807 (View on PubMed)

Other Identifiers

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P051060

Identifier Type: -

Identifier Source: org_study_id

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