University of Miami
| We are conducting a randomized clinical trial designed to assess the outcome of monochorionic twin pregnancies affected by selective intrauterine growth restriction |
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Sponsored by University of Miami |
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We are conducting a randomized clinical trial designed to assess the outcome of monochorionic twin pregnancies affected by selective intrauterine growth restriction (IUGR) and absent or reverse end-diastolic velocity (AEDV) 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 this 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. Patients with IUGR without AEDV will also be invited to participate in the trial in an observational arm. This protocol is approved by the Food and Drug Administration, the Institutional Review Board of the University of Miami, the Institutional Review Board of the University of Southern California, Florida and the Office of Clinical Research at General Hospital. Physicians interested in referring patients may download and fax our IUGR referral form or sign in for electronic referrals.
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INCLUSION CRITERIA: -Gestational age of 16-24 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. IUGR: Estimated Fetal Weight (g) at or Below the 10th Percentile . 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 an MVP of more than 8 cm in the other sac. - Presence of major congenital anomalies. - Both twins have an 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. WEBINAR Selective IUGR Randomized
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For further information, please contact: University of Southern California |
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