Oxford Luteal Dysfunction and Placental Insufficiency Study

NCT07072052 | Not Yet Recruiting

• 1 other identifier: PID17872
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

High blood pressure (BP) affects approximately 1 in 10 pregnancies. About half of women with high blood pressure in pregnancy develop a serious complication called preeclampsia, which kills over 70,000 women and 500,000 babies every year worldwide. Despite its devastating impact, scientists know little about preeclampsia prevention or treatment. Research has shown that preeclampsia results mainly from an abnormal attachment of the placenta to the lining of the womb. In the first 8 weeks of pregnancy, placental attachment depends on the release of hormones (for example, progesterone) by a gland in the ovary called the corpus luteum. Low blood levels of progesterone in early pregnancy are associated with a reduced chance of having a live baby and higher risk of miscarriage. Giving progesterone to women at risk of miscarriage in early pregnancy reduces their chance of developing preeclampsia by nearly 40%. These results highlight the crucial role of the corpus luteum in normal pregnancy, but there is a need for high-quality studies to identify women whose corpus luteum may be defective. Giving these women medicines to treat corpus luteal defects may lead to normal attachment of the placenta, reducing the risk of pregnancy complications such as preeclampsia. The investigators propose a study that will investigate whether ultrasound features of the corpus luteum and blood and urine levels of corpus luteal hormones may predict preeclampsia.

Conditions

Pre-eclampsia

Keywords

corpus luteum; pre-eclampsia; early pregnancy; prognostic marker; risk stratification

Outcome Measures

Primary Outcomes (2)

• Correlation between early luteal secretory product levels and preeclampsia risk

  To evaluate the correlation between individual levels of corpus luteum secretory products at \<8 weeks' gestation: progesterone (ng/mL), oestradiol (pmol/mL), vascular endothelial growth factor (VEGF) and Relaxin-2, measured in serum/plasma and the predicted probability (%) of developing preeclampsia at 10-14 weeks' gestation using the validated Fetal Medicine Foundation Preeclampsia Prediction Algorithm.

  Collected data and samples will be analysed blindly throughout the study and compared between the two main time points: <8 weeks' gestation (research visit 1) 10-14 weeks' gestation (research visit 2)

• Correlation between luteal ultrasound features and preeclampsia risk

  Evaluate the correlation between ultrasound imaging characteristics (corpus luteum size and vascularity index measured by power Doppler), and the calculated probability (%) of developing preeclampsia, as predicted by the Fetal Medicine Foundation Preeclampsia Prediction Algorithm at 10-14 weeks' gestation.

  Collected data and samples will be analysed throughout the study and compared between the two main time points: <8 weeks' gestation (research visit 1) 10-14 weeks' gestation (research visit 2)

Secondary Outcomes (8)

• Correlation between corpus luteal function and placental volume at 10-14 weeks

  Visit 1 (<8 weeks) and Visit 2 (10-14 weeks)

• Correlation between corpus luteum function and placental vascularity index at 10-14 weeks

  Visit 1 (<8 weeks) and Visit 2 (10-14 weeks)

• Incidence of pre-eclampsia

  These outcomes will be collected via telephone calls and medical records at the following weeks of pregnancy: Weeks 18-21 (usual care [UC] visit 1 - routine hospital attendance for anomaly scan), delivery and up to 4-6 weeks post delivery

• Incidence of fetal growth restriction

  These outcomes will be collected via telephone calls and medical records at the following weeks of pregnancy: Weeks 18-21 (usual care [UC] visit 1 - routine hospital attendance for anomaly scan), delivery and up to 4-6 weeks post delivery

• Incidence of preterm birth

  At delivery (≥24 weeks)

Study Arms (1)

Healthy pregnant volunteers

Healthy pregnant volunteers at \<8 completed weeks of gestation (i.e., up to 7 weeks and 6 days' gestation)

Other: No intervention planned

Interventions

No intervention planned OTHER

No interventions planned

Healthy pregnant volunteers

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant volunteers at \<8 completed weeks of gestation (i.e., up to 7 weeks and 6 days' gestation)

You may qualify if:

• Participant is willing and able to give written informed consent for participation in the study.
• Female, aged 16 years or above. As in vitro fertilisation is not undertaken in women younger than 18 years, those with pregnancies resulting from natural cycle frozen embryo transfer will be aged 18 years or above.
• Pregnancy \<8 completed weeks of gestation (i.e., up to 7 weeks and 6 days' gestation).
• Conception through any of the following means: unassisted ("natural"), ovulation induction (with clomifene citrate, letrozole or gonadotropin injections, including trigger injection), intrauterine insemination (with or without ovulation induction, including trigger injection), or natural cycle frozen embryo transfer.
• Intrauterine viable pregnancy confirmed on research ultrasound scan.
• Intention to deliver at Oxford University Hospitals.

You may not qualify if:

• Unable to read, or to understand written or spoken English.
• Vaginal bleeding at first visit.
• Miscarriage at first visit, defined as fetal crown-rump length of 7 mm or longer with no visible heartbeat, OR gestational sac with a mean of 25 mm or greater in diameter with no visible fetal pole on ultrasonography.
• Evidence of ectopic pregnancy at first visit.
• Multiple pregnancy.
• Uterine pathology (e.g., uterine polyp, fibroid, septate uterus, uterus didelphys, bicornuate uterus, unicornuate uterus).
• Fresh in vitro fertilisation.
• Donor oocyte in vitro fertilisation.
• Frozen embryo transfer using hormone replacement therapy for endometrial preparation.
• Participation in any concurrent trials of medicinal products in pregnancy.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

All consenting participants will undergo venepuncture on two occasions: at \<8 weeks' gestation (research visit 1) and at 10-14 weeks' gestation (research visit Blood will be taken in the following formats and retained: EDTA plasma, Silica serum, SST serum, Lithium heparin, Citrate. There will additionally be urine samples and vaginal and rectal swabs for microbiome testing.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Pedro Melo, MD PhD MRCOG

  Nuffield Department of Women's and Reproductive Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Melo, MD PhD MRCOG

CONTACT

01865 221021; pedro.melo@wrh.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

GB (1)