NCT05186779

Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Center for Epidemiology and Health Research, Germany · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This multinational, prospective, active surveillance, registry study following two cohorts will include study participants 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 In-Vitro Fertilization (IVF)/Assissted Reproductive Technology (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.

Conditions

• Early Pregnancy Bleeding
• Recurrent Pregnancy Loss

Interventions

Type	Name	Description
DRUG	Progestagen	Subjects receiving treatment with any progestogen, including dydrogesterone, or other treatment in the first trimester of pregnancy following; (Cohort A) a diagnosis of early bleeding in pregnancy or recurrent pregnancy loss, or (Cohort B) following IVF/ART embryo transfer

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2022-01-11
• Last updated: 2023-08-14

Locations

1 site across 1 country: Germany