Status:
TERMINATED
Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy
Lead Sponsor:
Center for Epidemiology and Health Research, Germany
Collaborating Sponsors:
Abbott Products Operations AG
Conditions:
Early Pregnancy Bleeding
Recurrent Pregnancy Loss
Eligibility:
FEMALE
18-35 years
Brief 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 dydroge...
Eligibility Criteria
Inclusion
- Pregnant women who wish to sustain their pregnancy
- Women who have tested positive (blood or urine) for pregnancy in the first trimester
- treated with progestogens or any alternative treatment for early bleeding in pregnancy with evidence of an intrauterine pregnancy / unexplained recurrent OR pregnancy loss (with ≥ 2 previous pregnancy losses) with evidence of an intrauterine pregnancy OR having undergone IVF/ ART embryo transfer and taking progestogen for luteal phase support (LPS), with evidence of an intrauterine pregnancy
- Signed informed consent, allowing consent to contact all treating, or diagnosing HCP
- Able and willing to read and comprehend written instructions; comprehend and complete the questionnaires required by the protocol
Exclusion
- Serious disease or disease requiring teratogenic treatment (e.g., Lupus Erythematosus, Multiple Sclerosis, cancer)
- Multifetal pregnancy
- More than four (4) previous IVF embryo transfers
- Previous exposure to dydrogesterone in index pregnancy
- Documented substance abuse
- Treatment with hormones which are known to cause malformations
- Participation in an observational study that might, in the recruiting HCP's opinion, influence the assessment for the current study
- Participation in a randomized clinical trial in the last 3 months
- Previous enrollment in the PEARLY study
Key Trial Info
Start Date :
December 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05186779
Start Date
December 15 2021
End Date
July 14 2023
Last Update
August 14 2023
Active Locations (1)
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1
Center for Epidemiology and Health Research Berlin
Berlin, Germany, 10115