Oxford Luteal Dysfunction and Placental Insufficiency Study
ConditionPre-eclampsia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16+
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Healthy pregnant volunteers at \<8 completed weeks of gestation (i.e., up to 7 weeks and 6 days' gestation)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention planned
Other interventionNo interventions planned
Treatment groups
360 Participants
are divided into 1 treatment groupGroup A: Healthy pregnant volunteers1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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)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.
Time frame
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
1
Correlation between corpus luteal function and placental volume at 10-14 weeks
To determine the correlation between corpus luteum function (progesterone (ng/mL), oestradiol (pmol/mL), vascular endothelial growth factor (VEGF) and Relaxin-2, measured in serum/plasma and ultrasound imaging characteristics of corpus luteum size and vascularity) and placental volume (cm³) measured by 3D ultrasound at 10-14 weeks' gestation.
Time frame
Visit 1 (<8 weeks) and Visit 2 (10-14 weeks)2
Correlation between corpus luteum function and placental vascularity index at 10-14 weeks
To determine the correlation between corpus luteum function \<8 weeks (progesterone (ng/mL), oestradiol (pmol/mL), vascular endothelial growth factor (VEGF) and Relaxin-2, measured in serum/plasma and ultrasound imaging characteristics of corpus luteum size and vascularity) and placental vascularity index (from power Doppler ultrasound) at 10-14 weeks' gestation.
Time frame
Visit 1 (<8 weeks) and Visit 2 (10-14 weeks)3
Incidence of pre-eclampsia
Proportion (%) of participants who develop preeclampsia.
Time frame
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 delivery4
Incidence of fetal growth restriction
Proportion (%) of pregnancies affected by fetal growth restriction (FGR), defined as estimated fetal weight \<10th percentile or abdominal circumference \<3rd centile, or \<10th centile with Doppler abnormalities
Time frame
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 deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: