Early Pregnancy BleedingPEARLYNCT05186779
Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy
An observational study of Early Pregnancy Bleeding and Recurrent Pregnancy Loss, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy Bleeding, Recurrent Pregnancy Loss
- What is being tested?
- Progestagen
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2021to 14 Jul 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Epidemiology and Health Research Berlin
Berlin, 10115
About this study
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
- Being tested
- Progestagen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgestagenDrug
Also called Any other treatment for the indication as per cohort A or cohort B
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Early Pregnancy Bleeding/Recurrent Pregnancy loss Receives: Drug: Progestagen | |
| Cohort B | IVF/ART Receives: Drug: Progestagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at 6-12 weeks after the initial estimated date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Dec 2021
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Why it stopped: Challenges in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Products Operations AG
- Responsible party
- Principal investigator, Clare Barnett, MBBS (Hons) MPH, Center for Epidemiology and Health Research, Germany
- Investigators
- Clare Barnet, Principal investigator, ZEG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186779
- Sponsor's protocol ID
- DYDR5007
- Acronym
- PEARLY
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy
- ClinicalTrials.gov ID
- NCT05186779
- Acronym / sponsor ID
- PEARLY / DYDR5007
- Conditions
- Early Pregnancy Bleeding, Recurrent Pregnancy Loss
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Challenges in recruiting patients
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Abbott Products Operations AG
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: ProgestagenEarly Pregnancy Bleeding/Recurrent Pregnancy loss |
| Cohort B | – | Drug: ProgestagenIVF/ART |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgestagenAlso: Any other treatment for the indication as per cohort A or cohort BSubjects 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 | Drug | Cohort A, Cohort B |
Primary outcome
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
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
Results and safety
The study was stopped early (reason given: Challenges in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Barnet principal investigator
ZEG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy Bleeding and Recurrent Pregnancy Loss, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Challenges in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.