Not yet recruitingNAINTERVENTIONAL

5-Year Follow-up of Children and Mother After Expectant Management Versus Induction of Labor in Low-risk Nulliparous Women at 39 Weeks of Gestation

This study is a follow-up to a larger French trial called FRENCH-ARRIVE. That trial looked at women who were pregnant for the first time and had a low risk of complications. It compared two approaches: having labour started (induced) at 39 weeks of pregnancy versus waiting for labour to begin on its own (expectant management). The original trial focused on short-term benefits for the mother and baby, like lower rates of C-sections. This new study will check on the children and mothers five years later. They want to find out if reducing the length of pregnancy for some women by inducing labour at 39 weeks has any long-term effects on the children's health, particularly their brain development. Understanding these mid-term effects is important for helping pregnant women make informed decisions.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

4,200

Start

01 Apr 2026

Estimated completion

01 Sep 2032

Neurodevelopmental Disorders

What is this study about?

This study is a follow-up to a previous research project conducted in France, called FRENCH-ARRIVE. The original FRENCH-ARRIVE study looked at women who were having their first baby and had a low risk of complications. It compared two common ways of managing the end of pregnancy: either starting labour early at 39 weeks (called 'induction') or waiting for labour to begin naturally (called 'expectant management'). This comparison was important because a study in the US suggested that starting labour early at 39 weeks might offer some immediate benefits, like a lower chance of needing a C-section or developing high blood pressure for the mother.

Now, this new study wants to find out what happens to these children and their mothers five years later. It's really important to understand if there are any longer-term effects on a child's health and development, especially how their brain develops, if their mother had their labour induced early. The original FRENCH-ARRIVE study focused just on immediate outcomes, but doctors don't yet know if there are differences down the line depending on whether labour was induced at 39 weeks or started naturally later.

By collecting this information, researchers hope to give women and their doctors clearer guidance. Knowing the mid-term effects will help families make the best decisions about how to manage the end of pregnancy when someone reaches 39 weeks. This kind of information is crucial for the vast majority of pregnant women who reach this stage.

Key takeaways

This is a follow-up study looking at long-term effects.
It's for mothers and children who were part of the FRENCH-ARRIVE trial.
Researchers want to see if being induced at 39 weeks had long-term effects on the child compared to waiting for natural labour.
Participation involves filling out questionnaires about your child's development and your health.
The information gained will help future pregnant women make decisions.
It focuses on neurodevelopmental disorders, which are conditions affecting the brain's development.

Who may be eligible?

To be part of this follow-up study, you must have been one of the mothers who took part in the original FRENCH-ARRIVE trial. This means you were at least 18 years old, pregnant with your first baby (meaning you hadn't carried a pregnancy beyond 20 weeks before), and were expecting only one baby. Your pregnancy had to be between 37 and 38 weeks and 6 days when you joined the earlier study.

For your child to be included, both parents must agree. It's important that neither you nor your child had any of the specific health conditions or pregnancy complications that would have prevented you from joining the original FRENCH-ARRIVE trial. These included things like having certain serious medical conditions, a baby in a breech position, signs of early labour, or a placenta that was not in the right place.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Did you participate in the original FRENCH-ARRIVE trial?
Were you at least 18 years old when you joined that trial?
Was it your first pregnancy (no previous pregnancies beyond 20 weeks)?
Did you have a single baby (not twins or more)?
Are both you and your child's other parent happy for your child to take part?

Answer every question to see your result.

What does participation involve?

If you and your child are eligible and agree to take part, your involvement will be quite simple. You and your child will be asked to complete some questionnaires. These questionnaires are designed to gather information about your child's health and development, as well as your own well-being, five years after your baby was born. There are no medications involved and no hospital visits for this specific follow-up study. The total duration of your participation will involve completing these questionnaires at the five-year mark after your delivery.

Potential risks and benefits

The main benefit of taking part is contributing to important medical knowledge that will help future pregnant women and their families. This study aims to understand the long-term effects of different ways of managing pregnancy, which could lead to better guidance for care. There are very few risks, as participation mainly involves completing questionnaires. Your answers will be kept private. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your or your child's medical care.

Locations (1)

CHU Bordeaux
Verified postcode
Bordeaux, France

Common questions

What is the main goal of this study?

The main goal is to find out if there are any long-term effects on children's health, particularly their brain development, and on mothers, five years after their labour was either induced at 39 weeks or allowed to start naturally in the original FRENCH-ARRIVE trial.

Who is being asked to join this study?

This study is inviting mothers and their children who previously took part in the FRENCH-ARRIVE trial in France.

What does 'expectant management' mean?

'Expectant management' means waiting for labour to begin on its own, rather than doctors starting it artificially.

Will I have to take any medication or attend hospital appointments for this study?

No, this study only involves completing questionnaires. There are no medications or hospital appointments required for this follow-up.

Why is this study important for future pregnancies?

By understanding the mid-term effects of different labour management approaches, this study will help pregnant women and their doctors make more informed decisions about when and how to have a baby.

How to find out more

Loïc Sentilhes, MD, PhD

loic.sentilhes@chu-bordeaux.fr +33 5 56 79 55 79 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.