Clinical trial • Phase III • Other
NIFEDIPINE for Preterm premature rupture of membranes (PPROM)
Phase III trial of NIFEDIPINE for Preterm premature rupture of membranes (PPROM).
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Preterm premature rupture of membranes (PPROM)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-06-2024
- First CTIS Authorization Date
- 25-07-2024
Trial design
Randomised, placebo of nifedipine (placebo comparator); dose and schedule not specified in available ctis data-controlled Phase III trial in France.
- Randomised
- Yes
- Comparator
- Placebo of Nifedipine (placebo comparator); dose and schedule not specified in available CTIS data
- Target Sample Size
- 850
- Trial Duration For Participant
- 730
Eligibility
Recruits 850 Pregnant women are included (participants must be 18 years or older and French speaking). Informed consent must be signed by the adult participant. Neonates/children are involved for outcome assessment at 2 years of corrected age; subject information and informed consent forms for adults and parental authorities documents are provided (SIS and ICF adult; SIS and ICF parental authorities; parental follow-up documents), indicating parental/guardian consent procedures for child follow-up..
- Pregnancy Exclusion
- - Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, haemorrhagic placenta praevia, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
- Vulnerable Population
- Pregnant women are included (participants must be 18 years or older and French speaking). Informed consent must be signed by the adult participant. Neonates/children are involved for outcome assessment at 2 years of corrected age; subject information and informed consent forms for adults and parental authorities documents are provided (SIS and ICF adult; SIS and ICF parental authorities; parental follow-up documents), indicating parental/guardian consent procedures for child follow-up.
Inclusion criteria
- {"criterion_text":"- Preterm premature rupture of membranes (PPROM) between 22 0/7 - 33 6/7 weeks of gestation, as diagnosed by obstetric teams: the diagnosis is usually based on 2 positive criteria from maternal history, sterile speculum examination to confirm fluid leakage from the cervical canal and performance of a diagnostic test."}
- {"criterion_text":"- Singleton gestation"}
- {"criterion_text":"- Fetus alive at the time of randomization"}
- {"criterion_text":"- 18 years of age or older"}
- {"criterion_text":"- French speaking"}
- {"criterion_text":"- Affiliated to social security or an equivalent system"}
- {"criterion_text":"- Informed consent and signed"}
Exclusion criteria
- {"criterion_text":"- PPROM ≥ 24 hrs before diagnosis"}
- {"criterion_text":"- Ongoing tocolytic treatment at the time of PPROM"}
- {"criterion_text":"- Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization"}
- {"criterion_text":"- Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, haemorrhagic placenta praevia, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization"}
- {"criterion_text":"- Cervical dilation ≥ 5 cm"}
- {"criterion_text":"- Iatrogenic rupture caused by amniocentesis or trophoblast biopsy"}
- {"criterion_text":"- Major fetal anomaly"}
- {"criterion_text":"- Maternal allergy or contra-indication to Nifedipine or placebo drug components:"}
- {"criterion_text":"- Myocardial infarction"}
- {"criterion_text":"- Unstable angina pectoris"}
- {"criterion_text":"- Hepatic insufficiency"}
- {"criterion_text":"- Cardiovascular shock"}
- {"criterion_text":"- Beta blockers"}
- {"criterion_text":"- Cardiopathy"}
- {"criterion_text":"- Co-administration of diltiazem, rifampicine, transdermal nitrates or any antihypertensive medication"}
- {"criterion_text":"- Hypotension (systolic blood pressure < 90 mmHg)"}
- {"criterion_text":"- Participation to another interventional research (category 1) in which intervention could interfere with Tocoprom’s results (efficacy and safety)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is a composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity.","definition_or_measurement_approach":"Composite outcome including fetal death, neonatal death up to discharge from hospital and/or neonatal severe morbidity (as stated in the protocol)."}
Secondary endpoints
- {"endpoint_text":"- Prolongation of gestation","definition_or_measurement_approach":""}
- {"endpoint_text":"- Maternal morbidity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Neonatal minor morbidity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Outcomes at 2 years of corrected age","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 850
- Recruitment Window Months
- 147
- Consent Approach
- Adult participants (pregnant women) must be 18 years or older, French speaking, and provide signed informed consent. Subject information and informed consent forms for adults are provided (SIS and ICF adult). Parental authorities / parental consent documents are provided for child-related follow-up (SIS and ICF parental authorities, and follow-up parental communications for outcomes at 2 years).
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 850
France
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 611
- Number Of Sites
- 29
- Number Of Participants
- 850
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Gynecology
- Principal Investigator Name
- Loïc Sentilhes
- Principal Investigator Email
- loic.sentilhes@chu-bordeaux.fr
- Contact Person Name
- Loïc Sentilhes
- Contact Person Email
- loic.sentilhes@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- gynecology
- Principal Investigator Name
- Florence Bretelle
- Principal Investigator Email
- Florence.BRETELLE@ap-hm.fr
- Contact Person Name
- Florence Bretelle
- Contact Person Email
- Florence.BRETELLE@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- gyneecology
- Principal Investigator Name
- Eric Verspyck
- Principal Investigator Email
- Eric.Verspyck@chu-rouen.fr
- Contact Person Name
- Eric Verspyck
- Contact Person Email
- Eric.Verspyck@chu-rouen.fr
- Site Name
- Centre Hospitalier General De St Denis
- Department Name
- gynecology
- Principal Investigator Name
- Mireille Ruiz
- Principal Investigator Email
- mireille.ruiz@ch-stdenis.fr
- Contact Person Name
- Mireille Ruiz
- Contact Person Email
- mireille.ruiz@ch-stdenis.fr
- Site Name
- CHRU De Nancy
- Department Name
- Gynecology-obstetric
- Principal Investigator Name
- Olivier Morel
- Principal Investigator Email
- olivier.morel@chru-nancy.fr
- Contact Person Name
- Olivier Morel
- Contact Person Email
- olivier.morel@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- gynecology
- Principal Investigator Name
- Norbert Winer
- Principal Investigator Email
- norbert.winer@chu-nantes.fr
- Contact Person Name
- Norbert Winer
- Contact Person Email
- norbert.winer@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Gynecology
- Principal Investigator Name
- Franck Perrotin
- Principal Investigator Email
- Franck.Perrotin@med.univ-tours.fr
- Contact Person Name
- Franck Perrotin
- Contact Person Email
- Franck.Perrotin@med.univ-tours.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Gynecology
- Principal Investigator Name
- Matthieu Chamagne
- Principal Investigator Email
- matthieu.chamagne@aphp.fr
- Contact Person Name
- Matthieu Chamagne
- Contact Person Email
- matthieu.chamagne@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gynecology
- Principal Investigator Name
- Anne Gaël Cordier
- Principal Investigator Email
- anne-gael.cordier@aphp.fr
- Contact Person Name
- Anne Gaël Cordier
- Contact Person Email
- anne-gael.cordier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- gynecology
- Principal Investigator Name
- Roxane Gibert
- Principal Investigator Email
- roxane.gibert@chu-lille.fr
- Contact Person Name
- Roxane Gibert
- Contact Person Email
- roxane.gibert@chu-lille.fr
- Site Name
- Hopital Saint Joseph
- Department Name
- gynecology
- Principal Investigator Name
- Raoul Desbriere
- Principal Investigator Email
- rdesbriere@hopital-saint-joseph.fr
- Contact Person Name
- Raoul Desbriere
- Contact Person Email
- rdesbriere@hopital-saint-joseph.fr
- Site Name
- Centre Hospitalier De Valenciennes
- Department Name
- gynecology
- Principal Investigator Name
- Nadia Tillouche
- Principal Investigator Email
- tillouche-n@valenciennes.fr
- Contact Person Name
- Nadia Tillouche
- Contact Person Email
- tillouche-n@valenciennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gynecology
- Principal Investigator Name
- Aude Girault
- Principal Investigator Email
- aude.girault@aphp.fr
- Contact Person Name
- Aude Girault
- Contact Person Email
- aude.girault@aphp.fr
- Site Name
- Centre Hospitalier De Pau
- Department Name
- gynecology
- Principal Investigator Name
- Caroline Bohec
- Principal Investigator Email
- bohecc@ch-pau.fr
- Contact Person Name
- Caroline Bohec
- Contact Person Email
- bohecc@ch-pau.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gynecology
- Principal Investigator Name
- Alexandra Benachi
- Principal Investigator Email
- lexandra.benachi@abc.aphp.fr
- Contact Person Name
- Alexandra Benachi
- Contact Person Email
- lexandra.benachi@abc.aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gynecology
- Principal Investigator Name
- Dominique Luton
- Principal Investigator Email
- dominique.luton@aphp.fr
- Contact Person Name
- Dominique Luton
- Contact Person Email
- dominique.luton@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- gynecology
- Principal Investigator Name
- Chris Minella
- Principal Investigator Email
- chris.minella@chru-strasbourg.fr
- Contact Person Name
- Chris Minella
- Contact Person Email
- chris.minella@chru-strasbourg.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Gynecology
- Principal Investigator Name
- Elie Azria
- Principal Investigator Email
- eazria@hpsj.fr
- Contact Person Name
- Elie Azria
- Contact Person Email
- eazria@hpsj.fr
- Site Name
- Hopital NOVO
- Department Name
- Gynecology-obstetric
- Principal Investigator Name
- Christophe Poncelet
- Principal Investigator Email
- christophe.poncelet@ch-pontoise.fr
- Contact Person Name
- Christophe Poncelet
- Contact Person Email
- christophe.poncelet@ch-pontoise.fr
- Site Name
- Hopital Louis Mourier
- Department Name
- Gynécologie Obstétrique
- Principal Investigator Name
- Charles Egloff
- Principal Investigator Email
- charles.egloff@aphp.fr
- Contact Person Name
- Charles Egloff
- Contact Person Email
- charles.egloff@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gynecology
- Principal Investigator Name
- Gilles Kayem
- Principal Investigator Email
- gilles.kayem@aphp.fr
- Contact Person Name
- Gilles Kayem
- Contact Person Email
- gilles.kayem@aphp.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- gynecology
- Principal Investigator Name
- Julievirginie Blanc
- Principal Investigator Email
- julievirginie.blanc@ap-hm.fr
- Contact Person Name
- Julievirginie Blanc
- Contact Person Email
- julievirginie.blanc@ap-hm.fr
- Site Name
- Centre Hospitalier Intercommunal De Poissy Saint Germain
- Department Name
- gynecology
- Principal Investigator Name
- Paul Berveiller
- Principal Investigator Email
- paul.berveiller@uvsq.fr
- Contact Person Name
- Paul Berveiller
- Contact Person Email
- paul.berveiller@uvsq.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- gynecology
- Principal Investigator Name
- Celine Chauleur
- Principal Investigator Email
- celine.chauleur@chu-st-etienne.fr
- Contact Person Name
- Celine Chauleur
- Contact Person Email
- celine.chauleur@chu-st-etienne.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- gynecology
- Principal Investigator Name
- Edouard Lecarpentier
- Principal Investigator Email
- edouard.lecarpentier@chicreteil.fr
- Contact Person Name
- Edouard Lecarpentier
- Contact Person Email
- edouard.lecarpentier@chicreteil.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Gynecology
- Principal Investigator Name
- Denis Gallot
- Principal Investigator Email
- dgallot@chu-clermontferrand.fr
- Contact Person Name
- Denis Gallot
- Contact Person Email
- dgallot@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- gynecology
- Principal Investigator Name
- Véronique Beaudoux
- Principal Investigator Email
- veronique.beaudoux@chu-angers.fr
- Contact Person Name
- Véronique Beaudoux
- Contact Person Email
- veronique.beaudoux@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- gynecology
- Principal Investigator Name
- Michel Dreyfus
- Principal Investigator Email
- dreyfus-m@chu-caen.fr
- Contact Person Name
- Michel Dreyfus
- Contact Person Email
- dreyfus-m@chu-caen.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gynecology
- Principal Investigator Name
- Amélie Benbara
- Principal Investigator Email
- amelie.benbara@aphp.fr
- Contact Person Name
- Amélie Benbara
- Contact Person Email
- amelie.benbara@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"Ministère de la Santé","duties_or_roles":"Source of monetary support / funding","organisation_type":""}
Investigational products
- Investigational Product Name
- NIFEDIPINE
- Active Substance
- NIFEDIPINE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Has MIA numbers: N° 2023_195_1_2 (UNITHER DEVELOPPEMENT BORDEAUX) and N° 2023_200_1_2_3_10 (EPHP-AGEPS)
- Maximum Dose
- Max daily dose 100 mg; max total dose 160 mg (as provided in CTIS data)
- Investigational Product Name
- Placebo of Nifedipine
- Modality
- Other
- Authorisation Status
- MIA numbers listed at product/group level: N° 2023_195_1_2 (UNITHER DEVELOPPEMENT BORDEAUX) and N° 2023_200_1_2_3_10 (EPHP-AGEPS)
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