Randomized Clinical Trial: Expectant Management vs Laser Treatment of Monochorionic Twins With Severe Selective Intrauterine Growth Retardation and Absent or Reverse Diastolic Flow in the Umbilical Artery
Intrauterine Growth Retardation
About this trial
This is an interventional treatment trial for Intrauterine Growth Retardation focused on measuring Intrauterine Growth Retardation in Monochorionic Twins
Eligibility Criteria
Inclusion Criteria:
- Gestational age 16--24 weeks
- Sonographic evidence of monochorionicity: single placenta, same gender, absent twin-peak sign
- Diagnosis of IUGR present in one twin (fetal weight at or below the 10th percentile for gestational age)
- Persistent absent or reverse-end diastolic flow in the umbilical artery in the SIUGR twin
- Able to provide written informed consent
Exclusion Criteria:
- Patients unwilling to participate in the study, provide consent, or to be followed up
- Presence of twin-twin transfusion syndrome (TTTS) defined as a maximum vertical pocket (MVP) of ≤2 cm in one sac and MVP of ≥8 cm in the other sac.
- Presence of major congenital anomalies (anencephaly, acardia, spina bifida) or intracranial findings in either twin: IVH, porencephalic cysts, ventriculomegaly or other findings suggestive of brain damage.
- Both twins are <10th percentile
- Diastolic flow or intermittently absent end-diastolic flow in the umbilical artery in the SIUGR twin
- Unbalanced chromosomal complement (if known).
- Ruptured or detached membranes
- Placental abruption
- Chorioamnionitis
- Triplets
- Active labor
- Jehovah's witness
- Any other patient deemed inappropriate for the study by the principal investigator
- Placenta previa
Sites / Locations
- University of Southern California
- University of South Florida
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Surgery Group
Expectant Management Group
Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form. Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures.
Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.