NCT05186779 (PEARLY) is a clinical trial of Progestagen in Early Pregnancy Bleeding, sponsored by Center for Epidemiology and Health Research, Germany.

Who is sponsoring NCT05186779?

NCT05186779 is sponsored by Center for Epidemiology and Health Research, Germany.

What drugs are being tested in NCT05186779?

Interventions in NCT05186779: Progestagen.

What condition does NCT05186779 study?

NCT05186779 studies Early Pregnancy Bleeding, Recurrent Pregnancy Loss.

Is NCT05186779 still recruiting?

NCT05186779 is currently terminated. Last updated 14 August 2023.

Last reviewed 2023-08-14 · How we verify

NCT05186779: PEARLY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy

Terminated Last updated 14 August 2023

What this trial tests

trial testing Progestagen in Early Pregnancy Bleeding in 50 participants. Terminated before completion.

Timeline

15 December 2021

Primary endpoint
14 July 2023

14 July 2023

Quick facts

Lead sponsor	Center for Epidemiology and Health Research, Germany
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	50
Start date	15 December 2021
Primary completion	14 July 2023
Estimated completion	14 July 2023
Sites	1 location across Germany

Drugs / interventions tested

Progestagen — full drug profile →

Conditions studied

Early Pregnancy Bleeding — all drugs for Early Pregnancy Bleeding →
Recurrent Pregnancy Loss — all drugs for Recurrent Pregnancy Loss →

Sponsor

Center for Epidemiology and Health Research, Germany — full company profile →

Who can join

Adults 18 to 35, female only, with Early Pregnancy Bleeding or Recurrent Pregnancy Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Center for Epidemiology and Health Research, Germany trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05186779 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Center for Epidemiology and Health Research, Germany
Last refreshed: 14 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05186779.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing