MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

Hypertension Clinical Trial

— MOMA  

Official title:

Impact of a Single Second-trimester Plasma sFlt-1 and/or Urinary PlGF Assay on Maternofetal Morbidity/Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763672
• Other study ID #: P051060
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: March 26, 2013
• Start date: November 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Hypertension
• Intrauterine Growth Retardation
• Pre-Eclampsia
• Preeclampsia
• Pregnancy
• Primiparity

Intervention

Other:
• Transmission of sFlt-1 results to the investigator
Transmission of sFlt-1 results by the laboratory to the investigator
• 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.

Locations

Country	Name	City	State
France	Department of Gynecology Obstetrics and Reproductive Medicine, Hôpital Tenon, AP-HP, UPMC	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (13)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Feb 5. — View Citation

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. — View Citation

Luttun A, Carmeliet P. Soluble VEGF receptor Flt1: the elusive preeclampsia factor discovered? J Clin Invest. 2003 Mar;111(5):600-2. — View Citation

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. — View Citation

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. Epub 2004 Jul 29. — View Citation

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. — View Citation

Sibai B, Dekker G, Kupferminc M. Pre-eclampsia. Lancet. 2005 Feb 26-Mar 4;365(9461):785-99. Review. — View Citation

Stepan H, Geide A, Faber R. Soluble fms-like tyrosine kinase 1. N Engl J Med. 2004 Nov 18;351(21):2241-2. — View Citation

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. Epub 2003 Jan 21. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the maternal and fetal morbimortality score		During the pregnancy and the 3 first month of the child	Yes
Secondary	Child status		at 3 months post-delivery	Yes
Secondary	Length of hospital stay during pregnancy and post-partum periods		during pregnancy and post-partum periods	No
Secondary	Predictive value for vascula-renal disease of urinary PlGF as compared with plasmatic sFlt-1.		between 25 and 28 weeks of gestation	No