Recurrent MiscarriagePhase 4PREMINCT05725512
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
A Phase 4 study testing Prednisolone in people with Recurrent Miscarriage and Recurrent Pregnancy Loss, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Recurrent Miscarriage, Recurrent Pregnancy Loss, Habitual Abortion
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Jan 2024to 29 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 diseases (such as hypothyroidism or diabetes)).
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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 effectiveness 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 233ZA
Yentl Bequet, MD, +31 652334371, y.l.b.n.bequet@lumc.nl
Lisa Lashley, MD, PhD, MsC, e.e.l.o.lashley@lumc.nl
About this study
Official title: Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages, PREMI Trial
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.
Read more
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.
Read the detailed description
Rationale:
Recurrent miscarriage (RM) is defined as 2 or more spontaneous miscarriages. It affects 3% of all fertile couples and in less than 50% an underlying cause may be identified. Thus far, none of the therapies tested in women with unexplained RM showed improvement of the live birth rate (LBR).
As the fetus is a semi-allograft, which escapes maternal immune rejection in normal pregnancy, many studies proposed the involvement of immunological mechanism in RM.
Glucocorticoids could have an effect on these mechanisms. Indeed, a recent meta-analysis has shown a beneficial effect on live birth rate for treatment with prednisolone therapy (RR 1.58, 95% CI 1.23-2.02). The included trials however were inadequately powered, differed in inclusion criteria or contained co-intervention with heparin and aspirin. In addition, most patients were selected based on the natural killer cell density in prior uterine biopsy, though this has not yet proven to be a valid biomarker.
Objectives:
To assess the effectiveness of prednisolone administration, as compared to placebo, on the LBR in an unselected population of women with unexplained RM.
Secondary, the effectiveness of prednisolone on the LBR in various subgroups, the tolerability and safety of prednisolone, the cost-effectiveness and the effect on immune cell levels is studied.
Main study parameters/endpoints:
Primary outcome: live birth rate Secondary outcome: miscarriage rate, ongoing pregnancy rate, adverse events (including side effects and pregnancy complications), decidual immune cell level and direct costs.
Trial design:
Randomized double-blind, placebo controlled multi-center clinical trial. Follow up period ends 3 months after delivery (12 months after randomization).
Trial population:
Women with unexplained recurrent miscarriage, including at least 2 miscarriages, aged 18- 39 years are recruited in a new pregnancy with AD <7 weeks from 10 participating centers in the Netherlands (Coordinating center Leiden University Medical Centre, LUMC).
Diagnosis unexplained recurrent miscarriages is based on latest ESHRE guideline.
Intervention:
After a complete diagnostic work-up, eligible women will be asked to collect a sample of menstrual blood. Patients are then randomized for prednisolone or placebo in a subsequent pregnancy. Women are randomly assigned in a 1:1 ratio to prednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) or identical placebo tablets.
The participants will then receive prenatal visits according to standard care with their own treating physician. All patients will be asked to fill in questionnaires at randomization, and 3, 6 and 12 months after randomization. In a subgroup of patients participating in the LUMC and Radboud MC, additional analyses will be performed, aimed at elucidating the effect of prednisolone on level of different immune cell populations in miscarriage tissue or placenta.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks:
In the PREMI study the investigators will evaluate the effect of prednisolone on the live birth rate in patients with RM in a randomized, placebo-controlled trial. The risks and burden of participating in the trial are estimated as small. The risk of participation is the risk of prednisolone use; substantial evidence exists that prednisolone in this dosage and usage in first trimester is safe for mother and fetus.
Patients may however experience barriers for participation in this study, due to the possible assignment to the placebo-arm (with a possible nil effect on pregnancy outcome), as well as potential side effects. Considering the latter, in a previous feasibility trial no side effects were severe enough for women to stop taking medication. Moreover, to establish the most valid results as possible, there is no other solid manner to answer this research question than by conducting a well-designed double blinded placebo-controlled RCT.
- Conditions
- Recurrent Miscarriage, Recurrent Pregnancy Loss, Habitual Abortion, Miscarriage, Fertility Disorders
- Being tested
- Prednisolone, Placebo
- Keywords
- Recurrent pregnancy loss, Recurrent miscarriage, prednisolone
- Medical subject headings
- Abortion, Habitual, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Prednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) or identical placebo tablets for 8 weeks
PlaceboDrug
Placebo identical to prednisolone tablets
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Experimental | Prednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) Receives: Drug: Prednisolone |
| Placebo | Placebo comparator | Identical placebo tablets for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Birth of a living child beyond 24 weeks
Measured: Within 24 months after eligibility
Secondary outcomes (12)
Ongoing pregnancy
Fetal heartbeat on ultrasound scan at 12 weeks
Measured: At +/- 12 weeks of pregnancy
Congenital abnormalities
Number of children born with congenital deformity (such as cleft palate)
Measured: At or short after birth, within 24 months after eligibility
Gestational age
Gestational age measured in weeks after conception until delivery
Measured: After birth, within 24 months after eligibility
Survival at 28 days of neonatal life
Is newborn still alive 28 days after birth
Measured: 28 days postpartum
Adverse events
Side effect of steroids (eg: insomnia, mood changes, indigestion)
Measured: From start intervention until stop intervention (maximum of 7 weeks)
Pregnancy complications
Such as preeclampsia, pregnancy induced hypertension, HELLP and gestational diabetes
Measured: During pregnancy, maximum of 9 months
Direct and indirect costs
Cost directly and undirectly related to intervention in comparrison to standard care
Measured: After intervention, after a maximum of 24 months
Anxiety and depression
Anxiety and depression measured with questionnaire (HADS)
Measured: Measurement at start of pregnancy (randomisation), 3, 6 and 12 months after start
Quality of life (Health state)
Quality of life measured through questionnaire (EQ-5D-5L) mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Measurement at start of pregnancy (randomisation), 3, 6 and 12 months after start
Birthweight
Measured in kilograms at time of birth
Measured: At birth, within 24 months after eligibility
Productivity costs due to condition
Productivity loss and costs measured through questionnaire (iPCQ)
Measured: 6 and 12 months after randomisation
Medical consumption
Medical consumptoin expressed in e.g. number of visits measured through questionnaire (iMCQ)
Measured: 6 and 12 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start29 Jan 2024
- Primary completion29 Jul 2026 (estimated)
- Study completion29 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent MiscarriageStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, E.E.L.O. Lashley, MD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725512
- Sponsor's protocol ID
- LUMC-PREMI
- Acronym
- PREMI
- Status last verified
- May 2024
- First submitted
- 19 Jan 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Possibly various covariates among women with RM contribute to the effect of prednisolone on the live birth rate. To further study the effect of prednisolone in predefined subgroups we aim to conduct a individual participant data meta-analysis. These subgroups include groups defined on female age, number of previous miscarriages, antinuclear antibodies positivity and TPO antibodies positivity
Publications
Bequet Y, van der Hoorn ML, Eikmans M, Van der Molen R, le Cessie S, van Geloven N, van den Akker-van Marle E, Vermeulen M, van den Berg M, de Bruin JP, Cantineau A, Huppelschoten D, Meuleman T, Mulders A, Al-Nasiry S, Teklenburg G, Verhoeve H, Visser J, van der Zanden M, Goddijn M, Lashley E. Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study). BMJ Open. 2025 Jun 19;15(6):e096545. doi: 10.1136/bmjopen-2024-096545.
PubMed 40537239
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages, PREMI Trial
- ClinicalTrials.gov ID
- NCT05725512
- Acronym / sponsor ID
- PREMI / LUMC-PREMI
- Conditions
- Recurrent Miscarriage, Recurrent Pregnancy Loss, Habitual Abortion, Miscarriage, Fertility Disorders
- Keywords
- Recurrent pregnancy loss, Recurrent miscarriage, prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- 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
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 29 Jul 2026 (estimated)
- Study completion
- 29 Jul 2027 (estimated)
- First posted
- 13 Feb 2023 (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.
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.
Detailed description
Rationale:
Recurrent miscarriage (RM) is defined as 2 or more spontaneous miscarriages. It affects 3% of all fertile couples and in less than 50% an underlying cause may be identified. Thus far, none of the therapies tested in women with unexplained RM showed improvement of the live birth rate (LBR).
As the fetus is a semi-allograft, which escapes maternal immune rejection in normal pregnancy, many studies proposed the involvement of immunological mechanism in RM.
Glucocorticoids could have an effect on these mechanisms. Indeed, a recent meta-analysis has shown a beneficial effect on live birth rate for treatment with prednisolone therapy (RR 1.58, 95% CI 1.23-2.02). The included trials however were inadequately powered, differed in inclusion criteria or contained co-intervention with heparin and aspirin. In addition, most patients were selected based on the natural killer cell density in prior uterine biopsy, though this has not yet proven to be a valid biomarker.
Objectives:
To assess the effectiveness of prednisolone administration, as compared to placebo, on the LBR in an unselected population of women with unexplained RM.
Secondary, the effectiveness of prednisolone on the LBR in various subgroups, the tolerability and safety of prednisolone, the cost-effectiveness and the effect on immune cell levels is studied.
Main study parameters/endpoints:
Primary outcome: live birth rate Secondary outcome: miscarriage rate, ongoing pregnancy rate, adverse events (including side effects and pregnancy complications), decidual immune cell level and direct costs.
Trial design:
Randomized double-blind, placebo controlled multi-center clinical trial. Follow up period ends 3 months after delivery (12 months after randomization).
Trial population:
Women with unexplained recurrent miscarriage, including at least 2 miscarriages, aged 18- 39 years are recruited in a new pregnancy with AD <7 weeks from 10 participating centers in the Netherlands (Coordinating center Leiden University Medical Centre, LUMC).
Diagnosis unexplained recurrent miscarriages is based on latest ESHRE guideline.
Intervention:
After a complete diagnostic work-up, eligible women will be asked to collect a sample of menstrual blood. Patients are then randomized for prednisolone or placebo in a subsequent pregnancy. Women are randomly assigned in a 1:1 ratio to prednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) or identical placebo tablets.
The participants will then receive prenatal visits according to standard care with their own treating physician. All patients will be asked to fill in questionnaires at randomization, and 3, 6 and 12 months after randomization. In a subgroup of patients participating in the LUMC and Radboud MC, additional analyses will be performed, aimed at elucidating the effect of prednisolone on level of different immune cell populations in miscarriage tissue or placenta.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks:
In the PREMI study the investigators will evaluate the effect of prednisolone on the live birth rate in patients with RM in a randomized, placebo-controlled trial. The risks and burden of participating in the trial are estimated as small. The risk of participation is the risk of prednisolone use; substantial evidence exists that prednisolone in this dosage and usage in first trimester is safe for mother and fetus.
Patients may however experience barriers for participation in this study, due to the possible assignment to the placebo-arm (with a possible nil effect on pregnancy outcome), as well as potential side effects. Considering the latter, in a previous feasibility trial no side effects were severe enough for women to stop taking medication. Moreover, to establish the most valid results as possible, there is no other solid manner to answer this research question than by conducting a well-designed double blinded placebo-controlled RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Experimental | Drug: PrednisolonePrednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) |
| Placebo | Placebo comparator | Drug: PlaceboIdentical placebo tablets for 8 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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 diseases (such as hypothyroidism or diabetes)).
- The miscarriages include:
- 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
Key exclusion criteria (23 listed)
- 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
- 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)
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 |
|---|---|---|
| PrednisolonePrednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) or identical placebo tablets for 8 weeks | Drug | Prednisolone |
| PlaceboPlacebo identical to prednisolone tablets | Drug | Placebo |
Primary outcome
Live birth rate
Time frame: Within 24 months after eligibility
Birth of a living child beyond 24 weeks
12 secondary outcomes
Ongoing pregnancy
Time frame: At +/- 12 weeks of pregnancy
Congenital abnormalities
Time frame: At or short after birth, within 24 months after eligibility
Gestational age
Time frame: After birth, within 24 months after eligibility
Survival at 28 days of neonatal life
Time frame: 28 days postpartum
Adverse events
Time frame: From start intervention until stop intervention (maximum of 7 weeks)
Pregnancy complications
Time frame: During pregnancy, maximum of 9 months
Direct and indirect costs
Time frame: After intervention, after a maximum of 24 months
Anxiety and depression
Time frame: Measurement at start of pregnancy (randomisation), 3, 6 and 12 months after start
Quality of life (Health state)
Time frame: Measurement at start of pregnancy (randomisation), 3, 6 and 12 months after start
Birthweight
Time frame: At birth, within 24 months after eligibility
Productivity costs due to condition
Time frame: 6 and 12 months after randomisation
Medical consumption
Time frame: 6 and 12 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 40537239Bequet Y, van der Hoorn ML, Eikmans M, Van der Molen R, le Cessie S, van Geloven N, van den Akker-van Marle E, Vermeulen M, van den Berg M, de Bruin JP, Cantineau A, Huppelschoten D, Meuleman T, Mulders A, Al-Nasiry S, Teklenburg G, Verhoeve H, Visser J, van der Zanden M, Goddijn M, Lashley E. Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study). BMJ Open. 2025 Jun 19;15(6):e096545. doi: 10.1136/bmjopen-2024-096545.
- Individual participant dataSharing planned: Yes. Possibly various covariates among women with RM contribute to the effect of prednisolone on the live birth rate. To further study the effect of prednisolone in predefined subgroups we aim to conduct a individual participant data meta-analysis. These subgroups include groups defined on female age, number of previous miscarriages, antinuclear antibodies positivity and TPO antibodies positivity
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone in people with Recurrent Miscarriage and Recurrent Pregnancy Loss, run by Leiden University Medical Center at 1 site in Netherlands.
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 8 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 24 May 2024. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eileen Lashley, PhD (0031-715263362, e.e.l.o.lashley@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: Within 24 months after eligibility). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05725512, which also lists 1 linked publication.
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 24 May 2024.