Prednisolone administration in women with unexplained REcurrent MIscarriages

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503220-76-01

Acronym

LUMC-PREMI

Enrollment

490

Registered

2023-10-05

Start date

2024-02-13

Completion date

Unknown

Last updated

2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained recurrent miscarriages

Brief summary

Last study subject has completed last visit and all data is gathered

Detailed description

DSMB advises to stop trial (for feasibility, slow inclusion rate, safety concerns etc.)

Interventions

DRUGPlacebo tablet (per tablet) Base granulate(3)

DRUGIn-house

DRUGBiding/filling agent 152 mg Talc 0 H2O (heated) (4)

DRUGPh. Eur. /In-house

DRUGGlidant

DRUG6.4 mg Magnesium stearate

DRUGPh. Eur.

DRUGLubricant

DRUG1.6 mg 3 Base granulate is an in-house granulate made for tablets with the following composition (5 kg): 4 kg of Lactose (100 M) 1 H2O

DRUG1 kg of Potato starch 0 H2O and approximately 720 ml gelatine spirit. 4 Talc is heated for 30 minutes at 250°C

DRUGto destroy spores of clostridium tetani. After heating talc is not additionally analysed.

DRUGPREDNISOLONE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Last study subject has completed last visit and all data is gathered	—

Secondary

Measure	Time frame
DSMB advises to stop trial (for feasibility, slow inclusion rate, safety concerns etc.)	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026