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NCT Number: NCT07796737

Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Miscarriages

The objective of the trial is to assess whether the combination of enoxaparine (LMWH) with progesterone increases the live birth rate compared to standard of care (no active treatment) in women with unexplained recurrent pregnancy loss.

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Key information

Conditions

Pregnancy Loss Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy Loss, Early Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of ≥2 consecutive unexplained miscarriages before 20 weeks of gestation.
  • Confirmed intrauterine pregnancy by ultrasound and/or serum β-hCG (≥5 weeks).
  • Willingness to follow study procedures (progesterone use, possible daily - injections) and provide written informed consent.
  • No medical contraindication to progesterone or LMWH.

Exclusion criteria

  • Documented antiphospholipid syndrome or any current anticoagulant requirement.
  • Anatomical abnormalities (e.g., significant uterine malformations, large fibroids) conclusively linked to RPL.
  • Known hypersensitivity to enoxaparine or heparins, or prior heparin-induced thrombocytopenia (HIT).
  • Use of systemic steroids (beyond standard pregnancy doses) for other immunological or inflammatory conditions.
  • Severe renal insufficiency (eGFR <30 mL/min), advanced liver disease, or other clinically significant systemic autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) that may affect pregnancy or study compliance.
  • Inability or unwillingness to comply with study requirements (language barriers, severe psychiatric conditions, etc.).
  • Abnormal karyotype

Treatment and study plan

Vaginal micronized progesterone

Drug

Vaginal micronized progesterone 800 mg daily administered in two divided doses .

Enoxaparin (LMWH)

Drug

Administered subcutaneously once daily at a weight-adjusted prophylactic dose according to body weight or applicable local guidelines.

Primary outcomes

  1. Live Birth Rate

    Time frame: At delivery (≥24+0 weeks of gestation)

    Proportion of randomized participants who deliver at least one live-born infant at ≥24+0 weeks of gestation.

Secondary outcomes

  1. Ongoing Pregnancy Rate at 22 Weeks

    Time frame: From enrollment to the end of 22 weeks of the index pregnancy.

    Proportion of randomized participants with an ongoing intrauterine pregnancy at 22+0 weeks of gestation, confirmed by ultrasound demonstrating fetal cardiac activity.

  2. Maternal Complications

    Time frame: From enrollment to the end of treatment at 6 weeks post-labor.

    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).

  3. Neonatal Outcomes:

    Time frame: From enrollment to the end of treatment at 6 weeks post-labor.

    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.

  4. Safety of the trial medication

    Time frame: From enrollment to the end of treatment at 6 weeks post-labor.

    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.

  5. Adherence and Tolerability:

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Brabcová, PhD

CONTACT

[email protected]

+420 22476 7496

Zdeněk Laštůvka, MD, PhD

CONTACT

[email protected]

+420 224767577

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

Randomized Open-Label Controlled Trial Evaluating the Efficacy of Low Molecular Weight Heparin Added to Progesteron in Recurrent Miscarriages

Acronym: PREMISE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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