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Purpose

This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 29 wks plus 5 d (so that occlusion is done at the latest on 29 wks plus 6 d) - Estimated to have severe pulmonary hypoplasia, defined prenatally as: O/E LHR <25 %, irrespective of the liver position - 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

Exclusion Criteria

  • 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 - Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria - 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
expectant management during pregnancy 		watchful waiting during pregnancy
  • Other: watchful waiting during pregnancy
    pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening
Experimental
fetal endoluminal tracheal occlusion 		fetoscopic balloon occlusion at 27 to 29+6 weeks of gestation
  • Procedure: fetal endoluminal tracheal occlusion
    percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks
    Other names:
    • Balt Goldbal 2 balloon

More Details

Status
Completed
Sponsor
University Hospital, Gasthuisberg

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.