TerminatedNot Applicable

Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy

Stopped: Challenges in recruiting patients

Germany50 participantsStarted 2021-12-15

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 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.

Timeframe: at 6-12 weeks after the initial estimated date of delivery

Trial details

NCT IDNCT05186779

SponsorCenter for Epidemiology and Health Research, Germany

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-14

View on ClinicalTrials.gov More Early Pregnancy Bleeding trials