MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

NCT00763672 | Completed

• 1 other identifier: P051060
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Primiparity; Hypertension; Preeclampsia; Intrauterine Growth Retardation

Keywords

Preeclampsia; Hypertension; Intra uterine growth retardation; Antiangiogenic factor; Prevention

Outcome Measures

Primary Outcomes (1)

• Reduction in the maternal and fetal morbimortality score

  During the pregnancy and the 3 first month of the child

Secondary Outcomes (3)

• Child status

  at 3 months post-delivery

• Length of hospital stay during pregnancy and post-partum periods

  during pregnancy and post-partum periods

• Predictive value for vascula-renal disease of urinary PlGF as compared with plasmatic sFlt-1.

  between 25 and 28 weeks of gestation

Study Arms (2)

A

OTHER

sFlt-1 status known

Other: Transmission of sFlt-1 results to the investigator

B

OTHER

sFlt-1 status unknown

Other: No transmission of the sFlt-1 results to the investigator

Interventions

Transmission of sFlt-1 results to the investigator OTHER

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

Also known as: Transmission of sFlt-1

A

No transmission of the sFlt-1 results to the investigator OTHER

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

Also known as: No transmission of the sFlt-1

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75020, France

Location

Related Publications (13)

• 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.

  PMID: 15733721 BACKGROUND

• 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.

  PMID: 15284201 BACKGROUND

• 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.

  PMID: 15622693 BACKGROUND

• 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.

  PMID: 12618519 BACKGROUND

• 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.

  PMID: 12538598 BACKGROUND

• 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.

  PMID: 12618513 BACKGROUND

• 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.

  PMID: 12727995 BACKGROUND

• 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.

  PMID: 18175241 BACKGROUND

• 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.

  PMID: 15548791 BACKGROUND

• 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.

  PMID: 14764923 BACKGROUND

• 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.

  PMID: 15331514 BACKGROUND

• 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.

  PMID: 15632339 BACKGROUND

• 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.

  PMID: 18388807 BACKGROUND

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadia BERKANE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 28, 2013

Record last verified: 2013-03

Locations

FR (1)