Study identification

PURI

https://redirect.ema.europa.eu/resource/45156

EU PAS number

EUPAS43631

Study ID

45156

Official title and acronym

Maternal and Newborn Safety profile of Progestogens in Early Pregnancy (PEARLY)

DARWIN EU® study

No

Study countries

China
Russian Federation
Türkiye

Study description

This multinational, prospective, active surveillance, registry study following two cohorts will include study participants (aged 18 to 35) who are pregnant and seeking any type of medical treatment, including dydrogesterone and other progestogens, for either (A) recurrent pregnancy loss and/or bleeding in early pregnancy or (B) as IVF/ART support. Pregnant women not taking progestogen and are advised an alternative non-medical treatment, in the context of bleeding in early pregnancy, recurrent pregnancy loss, or undergoing natural cycle frozen embryo transfer (NC-FET) can also be included in this study. Eligible study participants will be recruited via an international network of prescribing Health Care Practitioners (HCPs) in China, Turkey, and Russia with the aim to collect data related to maternal safety and newborn safety in women prescribed progestogens during early pregnancy. Study participants will be followed from early pregnancy until 6 – 12 weeks after giving birth. All malformations will be captured via direct contacts with the study participants. Study participants will be sent online questionnaires via the electronic Patient Reported Outcomes (ePRO) solution provided by MediData. Major malformations reported by the study participants will be validated by ZEG Berlin via relevant source documents and if necessary, via contacting the treating HCPs. The total study duration is planned for approximately 4 years including recruitment and follow-up. The study was terminated due to challenges in recruitment.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Clare Barnett

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Abbott Products Operations AG
Study protocol
Initial protocol

PEARLY_StudyProtocol_V02-00_ENCePP

English (1.27 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable