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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01177553
First received: August 5, 2010
Last updated: February 20, 2013
Last verified: February 2013

August 5, 2010
February 20, 2013
May 2007
February 2009   (final data collection date for primary outcome measure)
Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV and expectant management. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01177553 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Fetal/neonatal/infant survival of the AGA fetus 6 months after birth, comparing the SLPCV and expectant management groups. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intrauterine Growth Retardation
  • 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
    Other Name: SLPCV
  • 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.
    Other Name: expectant management (current accepted treatment)
  • Active Comparator: Surgery 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.

    Intervention: Procedure: selective laser photocoagulation of communicating vessels
  • Active Comparator: Expectant Management Group
    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.
    Intervention: Device: Expected Management

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01177553
IRB#105690
Yes
University of South Florida
University of South Florida
Not Provided
Principal Investigator: Ruben A Quintero, MD University of South Florida
University of South Florida
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP