Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05725512 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages

Study acronym: PREMI
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 24, 2024 (before its estimated July 29, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Phase: Phase 2 to Phase 4v4
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Jan 1, 2027 to Jul 29, 2026 · Completion date: Jul 1, 2027 to Jul 29, 2027 · 2 morev3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jan 1, 2027 to Jul 29, 2026
    • Completion date: Jul 1, 2027 to Jul 29, 2027
    • Start date changed from estimate of Jan 1, 2024 to Jan 29, 2024
    • Collaborators revised (11)

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Oct 1, 2023 to Jan 1, 2024 Enrollment target: 486 to 490 · Collaborators: 9 to 11v2 Show 2 more changesShow less
    • Enrollment target: 486 to 490
    • Collaborators: 9 to 11

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Recurrent miscarriages (RM) affects 3% of all fertile couples, but remains unexplained in most cases, limiting therapeutic options. Possibly the maternal immune system plays a role in recurrent miscarriage. Prednisolone suppresses the immune system and might enable development of normal pregnancy. In this randomized controlled clinical trial the investigators will study the effect of prednisolone on the live birth rate in patients with RM. Secondary, the tolerability and safety for mother and child and the cost-effectiveness is investigated. In the study one group of pregnant women with RM and gestational age \<7 weeks will receive prednisolone, the other group will receive a placebo. Total use of the medicine during this study is 8 weeks, further care during the study is routinely antenatal care. Subjects will be asked to fill in 4 short questionnaires and will have contact with a research nurse at different time points to gain information on the course of the pregnancy and possible side effects. Results of the study will be implemented in (inter) national guidelines, to effect everyday practice.
Trial Details
NCT Number NCT05725512
Lead Sponsor Leiden University Medical Center
Collaborators: Amsterdam University Medical Center, Erasmus Medical Center, Academisch Ziekenhuis Groningen, Maastricht University Medical Center, Isala, Catharina Ziekenhuis Eindhoven, Haaglanden Medical Centre, Amphia Hospital, Radboud University Medical Center, Jeroen Bosch Ziekenhuis, Onze Lieve Vrouwe Gasthuis
Conditions Recurrent Miscarriage, Recurrent Pregnancy Loss, Habitual Abortion, Miscarriage, Fertility Disorders
Enrollment 490 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov