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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177553
• Other study ID #: IRB#105690
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: February 20, 2013
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Retardation

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	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.	6 months	Yes
Secondary	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	Yes

External Links

•   USF-TGH Fetal Therapy Center