NCT01177553

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intrauterine Growth Retardation

Interventions

Type	Name	Description
PROCEDURE	selective laser photocoagulation of communicating vessels	Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. The use of these medications is safe in pregnancy in the doses and schedules outlined. Surgery will be performed under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. The patient will undergo either SLPCV or UCO depending on her choice. Patients will remain hospitalized for 24-48 hours. All subjects will be monitored during their hospital stay. Any unanticipated adverse events or serious adverse events will be reported to the IRB according to IRB reporting requirements. Prior to discharge from the hospital an investigator will perform a post-procedure ultrasound to assess fetal status
DEVICE	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.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2010-08-09
• Last updated: 2013-02-21
• Results posted: 2012-12-12

Locations

2 sites across 1 country: United States