Goal

The PE37 study is a clinical trial coordinated by BCNatal (Hospital Sant Joan de Déu, Hospital Clínic Barcelona) and the Hospital de la Santa Creu i Sant Pau in Barcelona, in which many other national and European centers participate. It aims to find a simple strategy to reliably identify mothers at higher risk of late onset preeclampsia and induce childbirth before complications can occur.

Why is it important to prevent late onset preeclampsia? Late onset preeclampsia is a complication that may appear at the end of pregnancy and have consequences for the health of the mother and baby. It is characterized by high blood pressure and signs of damage to organs such as the liver and kidneys. Most cases appear in women without any risk factor, making it difficult to detect in time and be able to take the necessary measures to safeguard the health of the mother and baby. Through the PE37 study we will evaluate whether, by means of a simple blood test at the end of pregnancy, it is possible to detect late onset preeclampsia and thus reduce the risks to the health of the mother and the negative impact on the newborn.

Start: 2021

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“Detecting and preventing late onset preeclampsia will reduce risks to the health of mothers and babies”

Participants and methodology

Who is the study aimed at? Any woman over the age of 18 who is pregnant for the first time, who is between week 35 and 37 of pregnancy and who has not had any previous complications can participate in the study. An estimated 5500 to 6000 women will participate in the study.

What is it? Participation consists only of a blood test taken between weeks 35 and 37 of pregnancy. The test will measure the levels of sFlt1 and PlGF, factors found in the blood that are called markers of placental function.

It is known that the ratio between these markers (sFlt1/PlGF) can identify mothers who will develop early hypertensive complications in pregnancy from those who will not with very high reliability. The PE37 study will examine whether the ratio between sFlt1 and PlGF can also identify mothers who will develop preeclampsia at the end of their pregnancy.

How will we do that? PE37 is a prospective, open-label randomized study with parallel groups. This means that to find out whether measuring the sFlt1 and PlGF markers using a blood test is better than not doing so, we will compare the results between two groups (the control and study groups). The moment the mother consents to participate in the study, she will be assigned to one of the two random groups:

Control group: An analysis will be carried out between weeks 35 and 37 of pregnancy, but neither the mother nor the medical team will know the result of the analysis and the hospital’s usual protocol for monitoring the pregnancy will continue.
Study group: An analysis will be performed between weeks 35 and 37 of pregnancy. The doctor will know the result and will guide the mother on the most appropriate way to continue her pregnancy based on this, the weeks of gestation and on clinical data as well as the usual tests for preeclampsia. If the result is normal, the pregnancy will continue with the mother’s usual midwife or doctor. In case of any abnormalities, the mothers of the study group will be contacted to have a consultation with a specialist in maternal-fetal medicine and may be offered an induction from the 37th week of pregnancy onwards, when it is known to be safe and before complications associated with late onset preeclampsia can occur.

All the mothers in the study, regardless of the group they are in, will receive all the medical care established by current protocols. In addition, there will be a later follow up, to assess the status of mothers and babies.

Innovation & Impact

The results of the study could change the current management of pregnancy globally and have a major impact on the quality of life of mothers and babies.

Team

The study will be coordinated by BCNatal’s maternal and medical professionals as well as the Hospital de la Santa Creu i Sant Pau in Barcelona:

Francesc Figueras
Principal Investigator BCNatal

Fàtima Crispi
Co-Researcher BCNatal

Francesca Crovetto
Co-Researcher BCNatal

Eduard Gratacós
Principal Investigator BCNatal

Elisa Llurba
Principal Investigator Hospital de la Santa Creu i Sant Pau

Participating centers

The study will be carried out in collaboration with other national and international hospitals:

Institute for the Care of Mother and Child (Prague, Czech Republic)
Centre of Postgraduate Medical Education, Obstetrics and Gynecology and Perinatal Medicine (Warsaw, Poland)
University Hospital Son Llàtzer (Palma, Spain)
Hospital Germans Trias i Pujol (Badalona, Spain)
Hospital del Mar (Barcelona, Spain)
Hospital Universitario La Paz (Madrid, Spain)
Hospital Clínico Zaragoza (Zaragoza, Spain)
La Fe University Hospital, Valencia (Valencia, Spain)
Arreixaca Hospital, Murcia (Murcia, Spain)
Hospital Materno Infantil of Las Palmas, Gran Canaria (Las Palmas, Gran Canaria, Spain)

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This is an investigator initiated study, which has the support of Roche to carry out the measurements and is currently seeking funding and awaiting the awarding of various grants.