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

Not Applicable

Completed

Conditions: Intrauterine Growth Retardation

Interventions: Device: Expected Management
Procedure: selective laser photocoagulation of communicating vessels

Registration Number: NCT01177553

Lead Sponsor: University of South Florida

Brief Summary: Intrauterine growth retardation (IUGR) occurs in approximately 3 to 10% of singleton pregnancies, in 9.1% of all twins and 9.9% of monochorionic twins. IUGR in monochorionic twins typically affects only one of the fetuses (selective IUGR or SIUGR). Spontaneous demise of the SIUGR twin can occur, and may result in concomitant demise (up to 40% risk) or severe neurologic handicap (up to 30% risk) of the other twin. These complications result from exsanguination of the appropriately grown (AGA) twin into the demised SIUGR twin through placental vascular communications.

Because the adverse effects to the AGA twin of the spontaneous demise of the SIUGR twin are mediated through placental vascular anastomoses, we have proposed obliterating such anastomoses via endoscopic fetal surgery. We have developed a technique that allows us to identify the vascular anastomoses present in monochorionic placentas. Briefly, deep AV communications are identified on the surface of the placenta by noting that the terminal end of the artery of one of the fetuses does not have a corresponding returning vein to the same fetus. We have speculated that the separation of the circulations may be of benefit in monochorionic twins affected by SIUGR by preventing the adverse effects that may result from the spontaneous demise of the IUGR twin. Our goal is to evaluate with a randomized clinical trial the outcome of SIUGR managed either expectantly or with SLPCV.

Study procedures will begin with confirmation of the diagnosis and screening criteria at the Qualified Clinical Center. The patient will sign the appropriate consents and then be randomized to her treatment group. Enrollment data will be submitted to the research coordinator in Coordinating Center in Tampa. Expectant management patients will be treated by the referring physicians. Laser patients will be treated at Coordinating Center in Tampa General Hospital or qualified laser center. They may return to the referring center for follow-up. After delivery, outcome data will be sent to the research coordinator in Coordinating Center in Tampa.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expectant Management Group	Expected Management	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.
Surgery Group	selective laser photocoagulation of communicating vessels	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.

Primary Outcome Measures

Name	Time	Method
Survival	6 months	Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.

Secondary Outcome Measures

Name	Time	Method
Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.	6 months

Trial Locations

Locations (2): University of Southern California
🇺🇸
Los Angeles, California, United States
University of South Florida
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Tampa, Florida, United States