Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
138
Countries
1
Sites
3
Preterm premature rupture of membrance in pregnancy.
The objective of the trial is to evaluate if tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes is associated with pregnancy prolongation compared to standard treatment.
Key facts
- Sponsor
- Vseobecna Fakultni Nemocnice V Praze
- Participant type
- Pediatric, Patients
- Age range
- In Utero, 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 24 Jun 2025 → ongoing
- Decision date (initial)
- 2025-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Safety, Therapy, Efficacy, Diagnosis
The objective of the trial is to evaluate if tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes is associated with pregnancy prolongation compared to standard treatment.
Secondary objectives 5
- To evaluate latency from premature rupture of membranes to birth.
- To assess the incidence of chorioamnionitis and funisitis.
- To determine short-term adverse maternal outcomes.
- To investigate short-term neonatal outcomes.
- To explore the microbiome of the mother and newborn (optional outcome).
Conditions and MedDRA coding
Preterm premature rupture of membrance in pregnancy.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073024 | Preterm premature rupture of membranes | 100000004868 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- age ≥ 18 years
- pPPROM Confirmed by Amnisure test and/or clinical signs of pPROM on examination
- Weeks of pregnancy 22+0 – 33+6
- Singleton pregnancy
- Signed informed consent form (ICF)
- Completely uncomplicated pregnancy util the occurrence of pPROM
Exclusion criteria 10
- Active labour (uterine activity leading to cervical dilatation greater than 4 cm)
- Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress.
- Multiple pregnancy
- Pregnancy with chromosomal or severe morphological abnormality.
- Signs of chorioamnionitis at the admission (clinical and/or laboratory).
- Patients with severe immunological compromise (immunodeficient).
- Patients with an oncological disease/immunosuppression.
- Patients with an active drug abuse.
- Non-compliant patients.
- Any contraindication according to the valid SmPC for the administered product
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of the study is the latency of pregnancy of more than 7 days from premature rupture of membranes to delivery.
Secondary endpoints 5
- Latency to birth
- Incidence of chorioamnionitis and funisitis
- Short-term adverse maternal outcomes
- Short-term neonatal outcomes
- Microbiome in mother and newborn - optional outcome
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
SCP104123707 · ATC
- Active substance
- Benzylpenicillin Procaine
- Substance synonyms
- PROCAINE BENZYLPENICILLIN, PENICILLIN G PROCAINE, PENICILLIN PROCAINE
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 17 IU international unit(s)
- Max total dose
- 125 IU international unit(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100375661 · ATC
- Active substance
- Demeclocycline Hydrochloride
- Route of administration
- ORAL USE
- Max daily dose
- 1 g gram(s)
- Max total dose
- 10 g/l gram(s)/litre
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01FA09 — CLARITHROMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP10332310 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 12 mg milligram(s)
- Max total dose
- 24 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP104123525 · ATC
- Active substance
- Ampicillin Sodium
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 12 g gram(s)
- Max total dose
- 84 g gram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR01 — AMPICILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12571209 · ATC
- Active substance
- Magnesium Sulfate
- Substance synonyms
- DRIED MAGNESIUM SULPHATE, MAGNESIUM SULPHATE, MAGNESII SULFAS
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 16 g gram(s)
- Max total dose
- 16 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA05 — MAGNESIUM SULFATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12505097 · ATC
- Active substance
- Betamethasone Valerate
- Substance synonyms
- BETAMETHASONE 17-VALERATE
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2800 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01GB03 — GENTAMICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vseobecna Fakultni Nemocnice V Praze
- Sponsor organisation
- Vseobecna Fakultni Nemocnice V Praze
- Address
- U Nemocnice 499/2, Nove Mesto Nove Mesto
- City
- Prague
- Postcode
- 128 00
- Country
- Czechia
Scientific contact point
- Organisation
- Vseobecna Fakultni Nemocnice V Praze
- Contact name
- Katerina Mackova
Public contact point
- Organisation
- Vseobecna Fakultni Nemocnice V Praze
- Contact name
- Katerina Mackova
Sponsor responsibilities
- Article 77 compliance
- Vseobecna Fakultni Nemocnice V Praze
- Contact point sponsor
- Vseobecna Fakultni Nemocnice V Praze
- Article 77 implementation
- Vseobecna Fakultni Nemocnice V Praze
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 138 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
Klinika Gynekologie Porodnictvi a Neonatologie, Apolinarska 441/18 Nove Mesto, 128 00, Prague
Fakultni Nemocnice Brno
Gynekologicko-porodnicka klinika, Obilni Trh 526/11, Veveri, Brno-Stred
The Institute For The Care Of Mother And Child
Department of Obstetrics and Gynecology, 157, Podolske Nabrezi 1110, Prague 4
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2025-06-24 | 2025-06-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol_2024-520237-77-00_v3_final | 3 |
| Protocol (for publication) | D1_Protocol 2024-520237-77-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy statement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Biobank ICF CZ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Biobank ICF CZ_2_final | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF CZ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF CZ_v2_final | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main ICF CZ_v3 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Ampicillin_sulbactam_SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Dexamed_SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Gentamicin_SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Klacid_SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Magnesium_sulfuricum_SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | PNC_G_SPC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-520237-77-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-11 | Czechia | Acceptable 2025-04-02
|
2025-04-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-05 | Czechia | Acceptable | 2025-08-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-07 | Czechia | Acceptable | 2025-10-07 |