Clinical trial • Phase IV • Other

MAGNESIUM SULFATE for Preterm premature rupture of membranes

Phase IV trial of MAGNESIUM SULFATE for Preterm premature rupture of membranes. 138 participants.

Overview

Trial Therapeutic Area: Other
Trial Disease: Preterm premature rupture of membranes
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 11-01-2025
First CTIS Authorization Date: 17-04-2025

Trial design

Phase IV trial across 3 sites in Czechia.

Biomarker Stratified: True, IL-6 in amniotic fluid (strata not specified)
Target Sample Size: 138

Eligibility

Recruits 138 Participants are adult pregnant women (age ≥ 18). 'isVulnerablePopulationSelected' is false. Informed consent is required (Signed informed consent form (ICF)). Subject information and ICF documents are provided (documents titled Main ICF CZ, Biobank ICF CZ), indicating Czech-language materials; assent not applicable as only adults are eligible..

Pregnancy Exclusion: Pregnancy with chromosomal or severe morphological abnormality.
Vulnerable Population: Participants are adult pregnant women (age ≥ 18). 'isVulnerablePopulationSelected' is false. Informed consent is required (Signed informed consent form (ICF)). Subject information and ICF documents are provided (documents titled Main ICF CZ, Biobank ICF CZ), indicating Czech-language materials; assent not applicable as only adults are eligible.

Inclusion criteria

{"criterion_text":"- age ≥ 18 years\n- pPPROM Confirmed by Amnisure test and/or clinical signs of pPROM on examination\n- Weeks of pregnancy 22+0 – 33+6\n- Singleton pregnancy\n- Signed informed consent form (ICF)\n- Completely uncomplicated pregnancy util the occurrence of pPROM"}

Exclusion criteria

{"criterion_text":"- Active labour (uterine activity leading to cervical dilatation greater than 4 cm)\n- Any contraindication according to the valid SmPC for the administered product\n- Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress.\n- Multiple pregnancy\n- Pregnancy with chromosomal or severe morphological abnormality.\n- Signs of chorioamnionitis at the admission (clinical and/or laboratory).\n- Patients with severe immunological compromise (immunodeficient).\n- Patients with an oncological disease/immunosuppression.\n- Patients with an active drug abuse.\n- Non-compliant patients."}

Endpoints

Primary endpoints

{"endpoint_text":"- The primary endpoint of the study is the latency of pregnancy of more than 7 days from premature rupture of membranes to delivery.","definition_or_measurement_approach":"Latency of pregnancy of more than 7 days from premature rupture of membranes to delivery; measured as time in days between premature rupture of membranes and delivery (endpoint = latency > 7 days)."}

Secondary endpoints

{"endpoint_text":"- Latency to birth\n- Incidence of chorioamnionitis and funisitis\n- Short-term adverse maternal outcomes\n- Short-term neonatal outcomes\n- Microbiome in mother and newborn - optional outcome","definition_or_measurement_approach":"Definitions/measurement approaches not detailed in the provided record; endpoints listed as stated above in the registry."}

Recruitment

Planned Sample Size: 138
Recruitment Window Months: 36
Consent Approach: Signed informed consent form (ICF) required from each participant (age ≥18). Subject information and ICF documents available (Main ICF CZ, Biobank ICF CZ, privacy statement) indicating materials in Czech. No assent procedures described (adult-only population).

Geography

Total Number Of Sites: 3
Total Number Of Participants: 138

Czechia

Earliest CTIS Part Ii Submission Date: 30-03-2025
Latest Decision Or Authorization Date: 07-10-2025
Processing Time Days: 191
Number Of Sites: 3
Number Of Participants: 138

Sites

Site Name: Fakultni Nemocnice Brno
Department Name: Gynekologicko-porodnicka klinika
Principal Investigator Name: Lukas Hruban
Principal Investigator Email: hruban.lukas@fnbrno.cz
Contact Person Name: Lukas Hruban
Contact Person Email: hruban.lukas@fnbrno.cz

Site Name: The Institute For The Care Of Mother And Child
Department Name: Department of Obstetrics and Gynecology
Principal Investigator Name: Petra Hanulikova
Principal Investigator Email: petra.hanulikova@upmd.eu
Contact Person Name: Petra Hanulikova
Contact Person Email: petra.hanulikova@upmd.eu

Site Name: Vseobecna Fakultni Nemocnice V Praze
Department Name: Klinika Gynekologie Porodnictvi a Neonatologie
Principal Investigator Name: Katerina Mackova
Principal Investigator Email: katerina.mackova@vfn.cz
Contact Person Name: Katerina Mackova
Contact Person Email: katerina.mackova@vfn.cz

Sponsor

Primary sponsor

Full Name: Vseobecna Fakultni Nemocnice V Praze
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Czechia

Investigational products

Investigational Product Name: MAGNESIUM SULFATE
Active Substance: MAGNESIUM SULFATE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Maximum Dose: 16 g

Investigational Product Name: DEXAMETHASONE
Active Substance: BETAMETHASONE SODIUM PHOSPHATE
Modality: Small molecule
Routes Of Administration: INTRAMUSCULAR INJECTION
Route: INTRAMUSCULAR INJECTION
Maximum Dose: 12 mg

Investigational Product Name: CLARITHROMYCIN
Active Substance: DEMECLOCYCLINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Maximum Dose: 1 g

Investigational Product Name: AMPICILLIN AND BETA-LACTAMASE INHIBITOR
Active Substance: AMPICILLIN SODIUM, SULBACTAM SODIUM, LIDOCAINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENIOUS INFUSION
Route: INTRAVENIOUS INFUSION
Maximum Dose: 12 g

Investigational Product Name: BENZYLPENICILLIN
Active Substance: BENZYLPENICILLIN PROCAINE, BENZATHINE BENZYLPENICILLIN, BENZYLPENICILLIN POTASSIUM
Modality: Small molecule
Routes Of Administration: INTRAVENIOUS INFUSION
Route: INTRAVENIOUS INFUSION
Maximum Dose: 17 IU

Investigational Product Name: GENTAMICIN
Active Substance: BETAMETHASONE VALERATE, GENTAMICIN SULFATE
Modality: Small molecule
Routes Of Administration: INTRAVENIOUS INFUSION
Route: INTRAVENIOUS INFUSION
Maximum Dose: 400 mg

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