- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05186779
Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy (PEARLY)
August 9, 2023 updated by: Clare Barnett, MBBS (Hons) MPH, Center for Epidemiology and Health Research, Germany
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10115
- Center for Epidemiology and Health Research Berlin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects receiving treatment with any progestogen, including dydrogesterone, or other treatment in the first trimester of pregnancy following; (A) a diagnosis of early bleeding in pregnancy or recurrent pregnancy loss,or (B) following IVF/ART embryo transfer will be eligible to be enrolled.
Subjects can be screened for the study only after an informed decision for dydrogesterone or alternative treatment has been made by the subject and the recruiting HCP.
Indication and contraindications according to the local market authorization/ summary of product characteristics (SmPC) should be carefully considered by the HCP.
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort A
Early Pregnancy Bleeding/Recurrent Pregnancy loss
|
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
Other Names:
|
Cohort B
IVF/ART
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the rate of major malformations in fetus by indication and by exposure to progestogens during the first trimester of pregnancy, with an emphasis on dydrogesterone versus non-dydrogesterone treatments.
Time Frame: at approximately 24 weeks of pregnancy
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at approximately 24 weeks of pregnancy
|
the rate of major malformations in newborns by indication and by exposure to progestogens during the first trimester of pregnancy, with an emphasis on dydrogesterone versus non-dydrogesterone treatments.
Time Frame: at 6-12 weeks after the initial estimated date of delivery
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at 6-12 weeks after the initial estimated date of delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Clare Barnet, ZEG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2021
Primary Completion (Actual)
July 14, 2023
Study Completion (Actual)
July 14, 2023
Study Registration Dates
First Submitted
December 9, 2021
First Submitted That Met QC Criteria
December 23, 2021
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DYDR5007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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