OxLuPIn

• Research type

  Research Study

• Full title

  Oxford Luteal Dysfunction and Placental Insufficiency Study (OxLuPIn)

• IRAS ID

  339009

• Contact name

  Pedro Senra Estrela Melo

• Contact email

  pedro.melo@wrh.ox.ac.uk

• Sponsor organisation

  University of Oxford / Research Governance, Ethics and Assurance

• Duration of Study in the UK

  1 years, 8 months, 31 days

• Research summary

  Background and Importance
  High blood pressure during pregnancy affects about 10% of pregnant women and can lead to preeclampsia, a severe condition that endangers both mothers and babies. Preeclampsia is linked to problems with the placenta's attachment to the womb early in pregnancy. This study focuses on the corpus luteum, a gland in the ovary that releases crucial hormones. Low progesterone levels from the corpus luteum are associated with higher miscarriage risks and reduced chances of a live birth. Additionally, giving progesterone early in pregnancy has shown to reduce preeclampsia by nearly 40%. The OxLuPIn study aims to investigate whether early markers from the corpus luteum can predict preeclampsia.

  Research Questions
  Can altered levels of hormones and ultrasound features of the corpus luteum before 8 weeks of pregnancy predict preeclampsia risk?
  Are there associations between corpus luteum function and placental development complications?
  Potential Benefits
  By identifying early markers of preeclampsia, this study aims to improve early diagnosis and intervention strategies, potentially leading to better outcomes for mothers and babies.

  Study Design
  This prospective observational cohort study will recruit 360 healthy pregnant women at less than 8 weeks of gestation. Participants will undergo blood tests, ultrasound scans, and provide urine samples at various points in their pregnancy.

  Participant Involvement
  Participants will:
  Undergo early pregnancy scans and provide blood and urine samples at less than 8 weeks and at 10-14 weeks of gestation.
  Have follow-up assessments at 18-21 weeks and at delivery.
  Complete questionnaires about their medical history and current pregnancy.

  Eligibility Criteria
  Eligible participants are pregnant women aged 16 years or older, at less than 8 weeks of gestation, with confirmed intrauterine pregnancy, and planning to deliver at Oxford University Hospitals. Women with certain conditions, such as current vaginal bleeding, miscarriage, or ectopic pregnancy, will be excluded.

  Locations and Funding
  The study will be conducted at Oxford University Hospitals NHS Foundation Trust, Oxford Fertility Clinic, and various community settings. It is funded by the John Fell Fund, Oxford University Press, and the Royal College of Obstetricians and Gynaecologists.

  By focusing on early detection and intervention, the OxLuPIn study hopes to improve maternal and fetal health outcomes.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  24/LO/0719

• Date of REC Opinion

  29 Nov 2024

• REC opinion

  Further Information Favourable Opinion