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

Qualifiers

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 design

Treatments tested in this trial

  • No intervention planned

Treatment groups

360 Participants
are divided into 1 treatment group

Sponsors and collaborators