Objective
To determine whether therapeutic amniocentesis in patients
with "stuck twins" will decrease the perinatal
mortality rate of the polyhydramniotic twin and the
oligohydramniotic twin with compared with expectant management
without amniocentesis
Conclusion
The study was terminated due to extremely low recruitment
- no conclusions could be made.
Clinical Centers
Tennessee, Southern California, Alabama, Wayne State,
Cincinnati, South Carolina, Bowman Gray, Chicago, Ohio State,
Oklahoma (observational only)
Major Eligibility Criteria
- "Stuck Twin" phenomenon: Polyhydramniotic
twin's largest vertical pocket ≥ 8 cm
- Gestational age < 280
weeks
- No major congenital malformation
- Delivery not imminent
- Informed consent
Groups
- Experimental = Therapeutic amniocentesis and expectant
management
- Placebo = Expectant management only
Sample Size
- Goal = 132 women (66/group)
Management Protocols
- Therapeutic Amnio:
- As soon as possible following randomization
- Repeated if hydramnios reaccumulates
- Tocolysis:
- Allowed (excluding Indomethacin)
- Gestational age < 34 weeks
- Contraction Stress Tests:
- Not permitted
- Amniocentesis:
- Allowed for assessment of fetal lung maturity or
relief of maternal respiratory embarrassment only
Outcome Measures
- Primary (each twin):
- Perinatal mortality (stillbirth or death prior to
discharge)
- Secondary (each twin):
- Stillbirth or death prior to 28 days of life
- Perinatal morbidity (IVH >3, NEC, RDS)
- Secondary (maternal):
- Gestational age at delivery
- Interval from randomization to delivery
- Indication for delivery
- Cesarean section rate
- Procedure-related variables
Timetable
- Randomization (n=6): 02/93-0/94
- Data Collection: 02/93-0/94
- Closeout/Final Analysis: 04/94-10/94
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