The Maternal Immune Response in Recurrent Adverse Pregnancy Outcome

  • Research type

    Research Study

  • Full title

    A Study of the Maternal Immune Response in Recurrent Adverse Pregnancy Outcome (The MIRAPO Study)

  • IRAS ID

    249895

  • Contact name

    David Williams

  • Contact email

    d.j.williams@ucl.ac.uk

  • Sponsor organisation

    University College London Joint Research Office (JRO)

  • Clinicaltrials.gov Identifier

    Z6364106/2018/08/21, UCL Data Protection Office Registration Number

  • Duration of Study in the UK

    5 years, 0 months, 1 days

  • Research summary

    Chronic Histiocytic Intervillositis (CHI), Villitis of Unknown Etiology (VUE) and Massive Perivillous Fibrin Deposition (MPFD) are three rare but devastating pregnancy disorders that cause recurrent stillbirths of severely growth-restricted babies. They appear to be caused by maternal antibodies against the placenta and an aggressive maternal immune response. At UCLH, we have prevented recurrence of CHI in 2 women by giving them Tacrolimus, a drug that is usually used to prevent rejection of kidney transplants and is safe in pregnancy.

    This project has 3 aims:

    1. To identify the maternal antibody that causes placental damage in CHI, VUE and MPFD.
    2. To discover whether Tacrolimus can suppress the aggressive immune response in these conditions.
    3. To discover biomarkers associated with these conditions, which could predict onset or severity of recurrence.

    At UCL, we will:

    1. Take a blood sample from women who have had CHI, VUE, MPFD or other causes of recurrent pregnancy loss. Then, in the laboratory, search for an antibody against a placental protein.

    2. Study DNA, immune cells and proteins in the blood of the mother, father and umbilical cord of families affected by these conditions.

    3. Study the immune response to the tuberculin skin test (TST) in each trimester of healthy pregnancy, in pregnant women with growth-restricted (very small) babies and in women taking Tacrolimus. The TST is a test that normally checks for immunity against tuberculosis (TB). It involves injecting a small amount of tuberculin, a non-infectious protein purified from TB bacteria, into the skin of each forearm. The immune reaction will be measured in tiny skin biopsies (less than 3mm in size) taken 2 days and 1 week later.

    These investigations will improve our understanding of the cause and treatment of CHI, VUE and MPFD as well as our knowledge of immune changes in healthy pregnancy.

  • REC name

    London - Fulham Research Ethics Committee

  • REC reference

    19/LO/0105

  • Date of REC Opinion

    6 Feb 2019

  • REC opinion

    Further Information Favourable Opinion