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New treatment option for Recurrent Miscarriage
Official title Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
ClinicalTrials.gov ID: NCT05725512
What this study is testing
What is Prednisolone?
Prednisolone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for recurrent miscarriage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Unexplained recurrent pregnancy loss: defined as the loss of ≥2 pregnancies, without any known cause for RM (parental chromosomal abnormalities...
- The miscarriages include:
- all consecutive or non-consecutive pregnancy losses before the 24th week of gestation verified by ultrasonography or uterine curettage and histology
- non-visualized pregnancies (including biochemical pregnancy losses and/or resolved and treated pregnancies of unknown location), verified by positive...
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any of the following diagnosis for the recurrent miscarriages
- Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin anti-bodies and/or beta-2 glycoprotein [IgG or IgM)
- Congenital uterine abnormalities (as assessed by 2D or 3d ultrasound, hys-terosonography, hysterosalpingogram or hysteroscopy)
- Abnormal parental karyotype
- Instable or exacerbation of auto-immune diseases such as diabetes, thyroid disease, inflammatory bowel diseases or SLE
See the full eligibility criteria
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Unexplained recurrent pregnancy loss: defined as the loss of ≥2 pregnancies, without any known cause for RM (parental chromosomal abnormalities, uterine anomalies, acquired or hereditary thrombophilia, endocrine...
- The miscarriages include:
- all consecutive or non-consecutive pregnancy losses before the 24th week of gestation verified by ultrasonography or uterine curettage and histology
- non-visualized pregnancies (including biochemical pregnancy losses and/or resolved and treated pregnancies of unknown location), verified by positive urine or serum hCG Ectopic and molar pregnancies are not included
- Age 18 - 39 years at randomization (likelihood of miscarriages due to chromosomal aberrations is higher when age \> 39 years. Such miscarriages are unlikely to be pre-vented by prednisolone therapy)
- Conception confirmed by urinary pregnancy test, with estimated gestational age ≤ 7weeks
- Willing and able to give informed consent in English or Dutch (IC)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any of the following diagnosis for the recurrent miscarriages
- Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin anti-bodies and/or beta-2 glycoprotein [IgG or IgM)
- Congenital uterine abnormalities (as assessed by 2D or 3d ultrasound, hys-terosonography, hysterosalpingogram or hysteroscopy)
- Abnormal parental karyotype
- Instable or exacerbation of auto-immune diseases such as diabetes, thyroid disease, inflammatory bowel diseases or SLE
- Inability to conceive within 1 year of recruitment
- Current treatment with systemic prednisolone or other immune suppressive medication (for any indication)
- Previous enrolment in the PREMI trial
- Enrolment in any other trial that studies the how well it works of an intervention on RM
- Contraindications to prednisolone use:
- Known allergy for prednisolone
- Acute bacterial infection or parasite infection
- Active COVID infection
- Systemic sclerosis
- Ulcus ventriculi or ulcus duodeni in medical history
- Obesity with BMI \>40
- Some drugs are known to interact with Prednisolone, and thus women on the following drugs are not eligible to take part in the PREMI trial:
- Enzyme inducers, such as carbamazepine, fenobarbital, fenytoïne and ri-fampicine
- CYP3A inhibitors, such as Cobicistat or Ritonavir
- Cyclosporine
- Digoxin
- Vaccination (with inactivated virus or bacteria) during prednisolone use is possibly less effective
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.