University of South Florida Tampa, FLORIDA.
| We are conducting a randomized clinical trial designed to assess the outcome of monochorionic twin pregnancies |
|
|
|
Sponsored by USF University of South Florida Tampa, FLORIDA. |
|
We are conducting a randomized clinical trial designed to assess the outcome of monochorionic twin pregnancies affected by selective intrauterine fetal growth retardation (IUGR) and absent or reverse diastolic velocity of the umbilical artery managed either expectantly or with laser therapy. Rationale Selective IUGR, defined as one fetus with a sonographic estimated fetal weight less than 10th percentile, occurs in approximately 15% of all monochorionic twins. Although these pregnancies may show amniotic fluid discordance, they do not meet criteria for twin-twin transfusion syndrome, defined as a maximum vertical pocket of more than 8 cm in one sac and less than 2 cm in the other. Spontaneous demise of the IUGR twin may occur in up to 40% of cases and is associated with up to 40% likelihood of demise of the co-twin, or the co-twin survives, up to 30% likelihood of neurological morbidity. The adverse effects associated with spontaneous demise of the IUGR twin are caused by perimortem fetofetal hemorrhage through patent placental vascular anastomoses. These complications do not occur in dichorionic twins, where there are no vascular anastomoses between the placentas. We have developed a laser surgical technique (selective laser photocoagulation of communicating vessels, SLPCV), which can effectively separate the circulations of two monochorionic fetuses. The purpose of the study is to compare expectant management vs. SLPCV in monochorionic twin pregnancies with selective IUGR and absent end-diastolic velocity in the umbilical artery of the IUGR twin. This protocol is approved by the Food and Drug Administration, the Institutional Review Board of the University of South Florida, Tampa, Florida and the Office of Clinical Research at Tampa General Hospital |
INCLUSION CRITERIA:
-Gestational age of 16-26 weeks. -Sonographic evidence of monochorionic-diamniotic twin pregnancy. -Diagnosis of IUGR in one twin (estimated fetal weight at or below the 10th percentile for gestational age). -Persistent absent or reverse end- diastolic velocity in the umbilical artery in the IUGR twin. EXCLUSION CRITERIA: - Presence of twin-twin transfusion syndrome (TTTS), defined as a maximum vertical pocket (MVP) of less than 2 cm in one sac and MVP of more than 8 cm in the other sac. - Presence of major congenital anomalies. - Both twins have estimated fetal weight at or below the 10th percentile for gestational age. - Unbalanced chromosomal complement (if known). - Ruptured or detached membranes. - Placental abruption. - Chorioamnionitis. - Triplets. - Active labor. - Placenta previa. FOR MORE INFORMATION, PLEASE CLICK HERE |
|
For further information, please contact: Fetal Therapy Center at TGH/USF |