Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Gasthuisberg
With
King's College Hospital NHS Trust
Hospital Clinic of Barcelona
Hopital Antoine Beclere
Hôpital Necker-Enfants Malades
University Hospital, Bonn
Mater Mothers' Hospital
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ospedale Pediatrico Bambino Gesù, Rome (IT)
Mount Sinai Hospital, Canada
Baylor College of Medicine
The University of Texas Health Science Center, Houston
Medical University of Warsaw
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Patients aged 18 years or more, who are able to consent
Singleton pregnancy
Anatomically and chromosomally normal fetus
Left sided diaphragmatic hernia
Gestation at randomization prior to 31 wks plus 5 d (so that occlusion is done at the latest on 31 wks plus 6 d)
Estimated to have moderate pulmonary hypoplasia, defined prenatally as:
* O/E LHR 25-34.9% (included; irrespective of the position of the liver)
* O/E LHR 35-44.9% (included) with intrathoracic liver herniation as determined by ultrasound or MRI
Acceptance of randomization and the consequences for the further management during pregnancy and thereafter.
The patients must undertake the responsibility for either remaining close to, or at the FETO center, or being able to travel swiftly and within acceptable time interval to the FETO center until the balloon is removed.
Intended postnatal treatment center must subscribe to suggested guidelines for "standardized postnatal treatment".
Provide written consent to participate in this RCT
Patient refusing randomization or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon
You may not be if
Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full
Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol.
Preterm labour, cervix shortened (\<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa
Patient age less than 18 years
Psychosocial ineligibility, precluding consent
Clareo Health | Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.
