Health Care Provider Pregnancy Registry
Support safety monitoring by providing information on pregnancies exposed to ellaOne®.
In agreement with the European Medicines Agency, this pregnancy registry was established to collect prospective or retrospective data on pregnancy outcomes following ellaOne® (ulipristal acetate 30 mg) exposure.
What is ellaOne® ?
ellaOne® is a female emergency contraceptive to be taken within five days (120 hours) following unprotected sexual intercourse or contraceptive failure (such as a missed pill, or a condom rupture).
ellaOne® should only be used strictly in accordance with the Product Information (Summary of Product Characteristics). Use outside of the approved indication is not recommended.
What is a Pregnancy registry ?
A pregnancy registry is a voluntary program designed to collect and evaluate medical information on pregnancies and outcomes reported, following exposure to a pharmaceutical product.
Purpose of the ellaOne® registry
The registry was created to collect information on any pregnancy exposed ellaOne®. The collection of data is needed to:
- Continuously monitor the safety profile of ellaOne® during its commercialization
- Assess pregnancy outcomes following ellaOne® exposure
- Contribute to pharmacovigilance and regulatory reporting
- Improve clinical understanding of maternal, foetal, and neonatal outcomes
Which pregnancies should be reported ?
Any pregnancy where:
- Patient became pregnant despite having taken ellaOne®, or
- Patient inadvertently took ellaOne® during pregnancy (e.g., unrecognized pregnancy at intake)
Why should you advise your patient to participate in this pregnancy registry ?
Participation in this pregnancy registry allows for the systematic collection of medically relevant information from patients who were exposed to ellaOne® during or shortly before pregnancy. These data contribute to the ongoing assessment of the safety profile of ulipristal acetate and may support future updates to the pregnancy section of the Summary of Product Characteristics (SmPC) for ellaOne®, where appropriate.
Please note that patients are not required to sign an Informed Consent Form attesting they accept their data to be collected in the framework of this registry. However, before reporting a pregnancy in the registry, you should inform the patient of the objectives and content of the registry. It is essential that patients also receive clear information regarding the collection, handling, and processing of their personal and medical data. Participation requires the patient’s agreement to collect her data in the registry. Patients should be reassured that applicable data protection requirements are respected and all information submitted to the registry is treated with strict confidentiality. Only anonymised data are used for analysis, reporting, and regulatory submissions, and no identifying information will appear in any outputs generated from this registry.
You may also advise your patient that she can participate directly by accessing the pregnancy registry herself, should she prefer to report independently.
We recommend that you print the document accessible on the link below.
Click here to download information on the pregnancy registry to be given to your patient.
What information is collected ?
The HCP questionnaire includes:
- Non‑identifiable patient demographics
- Timing and context of ellaOne® use
- Relevant medical and obstetric history
- Pregnancy progression and outcomes
- Neonatal health at birth
Privacy and confidentiality
Your patient’s identity remains strictly confidential.
Your contact information is used only to allow automated reminders for follow‑up reporting and clarification request.
How to participate
Click below to complete the HCP questionnaire.
It takes approximately 10–15 minutes.
