#Grand Rounds

Amnioexchange for Fetal Gastroschisis: Does it Reduce Morbidity?

BACKGROUND AND PURPOSE:

Direct exposure of fetal bowel to amniotic fluid can trigger significant ischemic and inflammatory processes
Based on experiments in animals, an amnioexchange procedure may reduce inflammation
Luton et al. (BJOG, 2019) investigated the benefits of using this amnioexchange procedure for fetal gastroschisis in humans

Prospective, interventional, randomized study (RCT)
Participants
- Pregnant women >18 years of age and ≥20 weeks gestation
- Singleton pregnancy
- Fetal gastroschisis (isolated)
Intervention (in utero)
- Amnioexchange procedure
  - Started at 30 weeks q2weeks | 300 ml amniotic fluid removed via 18 gauge needle and same volume of saline replaced
- A sham procedure
  - 1 ml saline injected subQ at the site and using a perfusion bag, sounds and movements were simulated similar to amnioexchange arm
In both arms
- Patients draped in a way that they were blinded
- Steroid injections at 30 weeks
- Postnatal minimal enteral feeding
Primary outcome
- A composite variable based on the duration of ventilation and parenteral nutrition
Secondary outcomes
- Effectiveness and safety of the amnioexchange procedure, including
  - The rate of perinatal death
  - Time to full enteral feeding
  - Primary closure
  - Late feeding disorders

Study stopped early, midway through recruitment due to
- Failure to recruit sufficient cases
- Failure at the last analysis to show any improvement in the amnioexchange arm
- Concern about side effects
64 patients were randomized
- 34 in amnioexchange group | 30 in placebo group
Primary outcome
- No difference in the composite criteria between groups
Secondary outcome
- No significant between-group differences in pregnancy outcome or complications
There was a relationship between digestive enzymes and inflammation factors in the amniotic fluid
- Bile acid levels are associated with both ferritin and interleukin 1β (IL1β); P < 0.01

The amnioexchange protocol used in this study is not an option for fetal care in humans
Future gastroschisis research should focus on modalities to reduce inflammatory pathways

< Previous

Next >