A Phase 3 interventional study of Vaginal Micronized Progesterone (Progesterone Besins) and Enoxaparin (Clexane) in Pregnancy Loss and Pregnancy Loss, Early, sponsored by General University Hospital, Prague. Not yet recruiting at 1 site in Czechia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by General University Hospital, Prague · Phase 3, Interventional, and Treatment
This prospective, single-centre, open-label, randomized Phase III superiority trial will enroll approximately 268 women aged 18-40 years with at least two consecutive unexplained miscarriages and a singleton intrauterine pregnancy confirmed by ultrasound at 5-7 weeks of gestation. Participants will be randomly assigned in a 1:1 ratio to standard antenatal care without active pharmacological treatment for recurrent pregnancy loss or to vaginal micronized progesterone plus subcutaneous enoxaparin. The primary outcome is live birth at or beyond 24+0 weeks of gestation. Study follow-up continues through six weeks postpartum. Delivery and postpartum outcomes will be obtained remotely using a structured participant-completed questionnaire. An optional exploratory translational sub-study involving one maternal blood sample at 10-12 weeks requires separate informed consent.
Participants will be randomized centrally using a computer-generated sequence with randomly varying block sizes and an electronic allocation system. In the intervention arm, vaginal micronized progesterone will be given at 400 mg twice daily through 16+0 weeks of gestation and 200 mg once daily at night from 16+1 through 36+0 weeks. Enoxaparin will be administered subcutaneously once daily at 40 mg for participants weighing less than 100 kg and 60 mg for participants weighing 100 kg or more, based on body weight at randomization, until 36+0 weeks. The control arm will receive routine antenatal care without study pharmacological treatment. Protocol-specific assessments will be coordinated by the single trial site and, where feasible, embedded in routine antenatal visits; no additional routine study visits are required. Intervention-arm participants will undergo safety monitoring including platelet count and renal function assessments. Maternal and neonatal outcomes will be collected by participant-completed questionnaire following delivery and at six weeks postpartum. Participants will remain under follow-up regardless of pregnancy outcome. Optional exploratory immunological analyses in maternal blood at 10-12 weeks will be conducted only after separate informed consent; optional biobanking likewise requires appropriate separate consent. External health-care providers may refer patients, but will not conduct trial-specific procedures.
221 studies on the registry are indexed under Abortion, Spontaneous; 44 are open to participants now.
This study's planned enrollment of 268 is above the median of 150 across 120 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →General University Hospital, Prague is the lead sponsor of 37 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 28, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive routine antenatal care according to local Czech clinical practice. No investigational medicinal product or active pharmacological treatment for recurrent pregnancy loss is administered in this arm. Folic acid or standard prenatal vitamins are recommended. Concomitant medication is recorded.
Participants receive vaginal micronized progesterone and daily subcutaneous enoxaparin from 5-7 weeks of gestation following confirmation of intrauterine pregnancy, with treatment continued as specified below through 36+0 weeks unless earlier discontinuation is clinically indicated or delivery occurs.
Drug: Vaginal Micronized Progesterone (Progesterone Besins) · Drug: Enoxaparin (Clexane)
Vaginal micronized progesterone 400 mg twice daily (total 800 mg/day) from treatment initiation at 5-7 weeks through 16+0 weeks of gestation, followed by 200 mg vaginally once daily at night from 16+1 through 36+0 weeks of gestation. Treatment may be interrupted or discontinued for protocol-specified safety reasons
Subcutaneous enoxaparin once daily, at a prophylactic dose based on maternal body weight at randomization: 4,000 anti-Xa IU (40 mg) for participants weighing less than 100 kg, or 6,000 anti-Xa IU (60 mg) for participants weighing 100 kg or more. Treatment starts at 5-7 weeks following pregnancy confirmation and continues through 36+0 weeks of gestation unless medically discontinued earlier. If delivery occurs before 36+0 weeks, treatment stops at the onset of labour.
Live Birth Rate
Proportion of randomized participants who deliver at least one live-born infant at 24+0 weeks of gestation or later. Live birth status and gestational age at delivery will be ascertained using the structured participant-completed postpartum questionnaire.
Time frame: At delivery (≥24+0 weeks of gestation)
Ongoing Pregnancy Rate at 22 Weeks
Proportion of randomized participants with an ongoing intrauterine pregnancy at 22+0 weeks of gestation, based on participant-reported information.
Time frame: From enrollment to the end of 22 weeks of the index pregnancy.
Maternal Complications
Incidence of pregnancy-related complications, including preeclampsia (defined by ISSHP), gestational hypertension, gestational diabetes, placental abruption, postpartum hemorrhage (defined as estimated blood loss \>500 mL following vaginal delivery or \>1000 mL following cesarean section).
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Neonatal Outcomes:
Birth weight (grams), APGAR scores at 1 and 5 minutes post-delivery (APGAR at 10 minutes may be recorded if available), admission to neonatal care unit (NICU), and presence of congenital anomalies confirmed postnatally. According to participant-reported records.
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Safety of the trial medication
Incidence of major bleeding events (overt bleeding requiring transfusion, surgical intervention, or hemodynamic intervention) and minor bleeding events (mucosal or injection-site bleeding), thrombocytopenia (defined as platelet count \<100,000/μL), hypersensivity, and injection-site reactions.
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Adherence and Tolerability:
Treatment discontinuation rate and reasons for discontinuation (including adverse events); participant-reported injection-site pain associated with LMWH treatment, assessed using a numerical rating scale from 0 (no pain) to 10 (worst imaginable pain); participant-reported missed doses of study treatment and reasons for missed doses; and completeness of medication diaries.
Time frame: Treatment discontinuation: from initiation at 5-7 weeks' gestation to 36+0 weeks or delivery. Pain and missed-dose outcomes: assessed at 20 and 34 weeks' gestation and 6 weeks postpartum.
Incidence of Fetal Growth Restriction
Proportion of pregnancies with fetal growth restriction as reported during antenatal care.
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Gestational Age at Delivery
Gestational age at delivery, expressed in completed weeks and days, ascertained from the structured participant-completed postpartum questionnaire.
Time frame: From enrollment to the end of treatment at 6 weeks post-labor.
Plan to share: No — GDPR requirements
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Progesterone · Enoxaparin sodium
General University Hospital, Prague