Health TrialsbyHealthPanel

Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Miscarriages

ConditionsPregnancy LossPregnancy Loss, Early
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorGeneral University Hospital, Prague

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: ARM ANo intervention 0 interventions
Group B: ARM BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Live Birth Rate

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

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

Secondary outcomes

1

Ongoing Pregnancy Rate at 22 Weeks

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

Time frame
From enrollment to the end of 22 weeks of the index pregnancy.
2

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.
3

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.

Time frame
From enrollment to the end of treatment at 6 weeks post-labor.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General University Hospital, Prague

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: