NCT03336463

Brief Summary

Recurrent pregnancy loss (RPL) is a clinical problem affecting 1-5% of couples of reproductive age. The contribution of thrombophilia to RPL is disputed. This controversy is partly due to low sensitivity of the genetic variants currently used to evaluate hereditary thrombophilia: the Leiden mutation (identified as rs6025) in the coagulation factor 5 (F5L) gene and mutation G20210A (identified as rs1799963) in the prothrombin (PT) gene. Our objective was to determine whether a wider algorithm that includes clinic and genetic variants associated with thrombophilia could be more useful in the prediction for RPL than FVL and PT alone.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

October 23, 2017

Last Update Submit

November 3, 2017

Conditions

Miscarriage, Recurrent

Keywords

Thrombophilia screeningGenetic risk score

Outcome Measures

Primary Outcomes (2)

  • Recurrent Pregnancy Loss

    Repeated clinical pregnancy loss and/or foetal death (≥ 2 consecutive or ≥ 3 non-consecutive) before the 20th weeks of pregnancy

    20 weeks

  • Pregnancy at term

    Pregnancy with life-birth

    20 weeks

Study Arms (2)

Controls

No intervention

Cases

No intervention

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include women with recurrent pregnancy loss (\> 2 consecutive or \> 3 non-consecutive) before the 20th week of pregnancy (cases) and women with at least 1 pregnancy at term (controls).

You may qualify if:

  • Women \>18 and \< 38 years old at the time of the first pregnancy.
  • Women with successful implantation and at least one full-term pregnancy
  • No chronic pathology

You may not qualify if:

  • Personal or family history of thrombosis
  • Personal history of obstetric complications Miscarriage or foetal death Pre-eclampsia or eclampsia Intrauterine growth restriction Placental abruption
  • Concomitant anticoagulant treatment and/or antiplatelet treatments during pregnancy
  • CASES
  • Repeated clinical miscarriages and/or foetal death (≥ 2 consecutive or ≥ 3 non- consecutive) before the 20th weeks of pregnancy, from spontaneous or assisted pregnancies.
  • Recurrent miscarriage with the same gametic origin.
  • Idiopathic origin:
  • Women \< 38 years old Non-severe seminal factor (sperm concentration \> 2 mill/ml) Normal karyotypes in both spouses (or in the male and the donor in the case of ovocyte donation) Antiphospholipid syndrome negative Normal or corrected thyroid function BMI \< 30
  • Diabetes
  • Chronic pathologies
  • Hydrosalpinx
  • Concomitant anticoagulant or antiplatelet treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Gendiag.exe, S.L.

Esplugues de Llobregat, Select State, 08950, Spain

Location

Institut d'Investigació Sant Pau

Barcelona, 08025, Spain

Location

Instituto Salud Carlos III

Madrid, 28029, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

IVI-RMA Valencia

Valencia, 46015, Spain

Location

Instituto de Investigaciones Sanitarias La Fe

Valencia, 46026, Spain

Location

IVI-RMA-London

London, W1G9RQ, United Kingdom

Location

Related Publications (1)

  • Soria JM, Morange PE, Vila J, Souto JC, Moyano M, Tregouet DA, Mateo J, Saut N, Salas E, Elosua R. Multilocus genetic risk scores for venous thromboembolism risk assessment. J Am Heart Assoc. 2014 Oct 23;3(5):e001060. doi: 10.1161/JAHA.114.001060.

    PMID: 25341889BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA extraction from saliva or blood samples

MeSH Terms

Conditions

Abortion, HabitualGenetic Risk Score

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenetic Predisposition to DiseaseDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eduardo S Salas, MD, PhD

    Ferrer inCode, S.L.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

November 8, 2017

Study Start

February 1, 2015

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

ES(7)GB(1)