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AzTrials

PregnancyMOMANCT00763672

MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

A study testing Transmission of sFlt-1 results to the investigator and No transmission of the sFlt-1 results to the investigator in people with Pregnancy and Primiparity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Pregnancy, Primiparity, Hypertension
What is being tested?
Transmission of sFlt-1 results to the investigator and No transmission of the sFlt-1 results to the investigator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,040 participants
Where
1 siteFrance
Study dates
Nov 2008to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Paris, 75020

Other trials in France

About this study

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

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.

Read the detailed 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).

Being tested
Transmission of sFlt-1 results to the investigator, No transmission of the sFlt-1 results to the investigator
Keywords
Preeclampsia, Hypertension, Intra uterine growth retardation, Antiangiogenic factor, Prevention
Medical subject headings
Hypertension, Pre-Eclampsia, Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transmission of sFlt-1 results to the investigatorOther

    Also called Transmission of sFlt-1

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

  • No transmission of the sFlt-1 results to the investigatorOther

    Also called No transmission of the sFlt-1

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

Study groups in NCT00763672
Study groupRoleWhat they receive
AOthersFlt-1 status known
Receives: Other: Transmission of sFlt-1 results to the investigator
BOthersFlt-1 status unknown
Receives: Other: No transmission of the sFlt-1 results to the investigator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in the maternal and fetal morbimortality score

    Measured: During the pregnancy and the 3 first month of the child

Secondary outcomes (3)

  1. Child status

    Measured: at 3 months post-delivery

  2. Length of hospital stay during pregnancy and post-partum periods

    Measured: during pregnancy and post-partum periods

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

    Measured: between 25 and 28 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMay 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,040 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00763672
Sponsor's protocol ID
P051060
Acronym
MOMA
Status last verified
Mar 2013
First submitted
30 Sep 2008
Last updated
28 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15733721

  • 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.

    PubMed 15284201

  • 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.

    PubMed 15622693

  • 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.

    PubMed 12618519

  • 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.

    PubMed 12538598

  • 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.

    PubMed 12618513

  • 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.

    PubMed 12727995

  • 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.

    PubMed 18175241

  • 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.

    PubMed 15548791

  • 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.

    PubMed 14764923

  • 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.

    PubMed 15331514

  • 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.

    PubMed 15632339

  • 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.

    PubMed 18388807

Questions about this trial

What is this clinical trial studying?

A study testing Transmission of sFlt-1 results to the investigator and No transmission of the sFlt-1 results to the investigator in people with Pregnancy and Primiparity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in the maternal and fetal morbimortality score (time frame: During the pregnancy and the 3 first month of the child). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763672, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.

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