Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome (TTTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01622049
First received: August 5, 2010
Last updated: March 13, 2013
Last verified: November 2012
  Purpose

Patients undergo a detailed ultrasound examination to rule out the presence of congenital anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS will be considered candidates for the trial. Patients will be counseled about the risks and benefits of all treatment options and will be free to choose any treatment option. They will then be asked to sign an informed consent. The procedure will be performed under local anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. An accessory port may be required in some cases. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted often during the procedure. An amniodrainage of the larger sac may be performed at the time of the procedure. The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on the first post operative day. Patients will undergo a weekly ultrasound examination for four weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders, absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein, ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive care unit will be followed through their discharge. Evidence of neurological or cardiac morbidity will be sought in each twin. If either of these complications is suspected, evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be followed up for neonatal, infant and childhood morbidity or mortality. It is requested that all placentas be delivered fresh to Tampa General Hospital in an icebox container for assessment. Placentas will be discarded after analysis.


Condition Intervention
Twin Twin Transfusion Syndrome
Device: Selective Laser Photocoagulation of Communicating Vessels

Study Type: Observational
Official Title: Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • The primary study objective is to evaluate neonatal/infant survival 6 months after birth. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary study objective is to evaluate the effects of surgery on postnatal neurological morbidity. For the purposes of this clinical trial, neurological morbidity includes any of the following conditions diagnosed within 6 months of birth [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: October 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TTTS treatment method
This is an observational trial. Patients who meet eligibility criteria and give written informed consent will have SLPCV. All subjects will receive ongoing standard-of-care prenatal care for the duration of their pregnancy from their referring perinatologist or obstetrician.
Device: Selective Laser Photocoagulation of Communicating Vessels
Patients will be admitted to Tampa General Hospital. Laboratory tests and anesthesia assessments will be completed. Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. Surgery will be performed preferably under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. Surgery will be performed with standard operative fetoscopy equipment and techniques. A trocar will be introduced in the amniotic cavity of the recipient. An amniotic fluid sample will be obtained for microbiological studies, and genetic analysis for clinical care only. The amniotic fluid will be discarded after analysis. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted. An amniodrainage of the larger sac may be performed
Other Name: SLPCV

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

To be eligible, patients must meet the following criteria:

  1. Maternal age 18 to 55 years
  2. Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
  3. Confirmed TTTS patients, who by definition meet the following sonographic criteria:

    1. Single placenta.
    2. Polyhydramnios: maximum vertical pocket >= 8 cm in the recipient twin, prior to amniodrainage.
    3. Oligohydramnios: maximum vertical pocket <=2 cm in the donor twin, prior to amniodrainage.
    4. Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic).
    5. Same gender, if visible.
  4. Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
  5. Patients with an anterior placenta may be included.
  6. Triplet gestations with two or three fetuses sharing the same placenta may be included.
  7. Patients must be able to give written informed consent. Inclusion Criteria 5.2 Exclusion Criteria

The following criteria would exclude patients from participation in the study:

  1. Patients unable or unwilling to participate in the study or to be followed up.
  2. Patients unable to give written informed consent.
  3. Presence of major congenital anomalies that may not warrant surgery.
  4. Known unbalanced chromosomal complement.
  5. Prior intentional septostomy (purposely making a hole in the dividing membrane).
  6. Ruptured membranes.
  7. Chorioamnionitis.
  8. Abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated ventriculomegaly (atrium 10-19 mm) may or may not be used an exclusion criteria.
  9. Placental abruption.
  10. Active labor.
  11. Jehovah's Witness.
  12. Any other patient deemed inappropriate for the study by the principal investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622049

Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Ruben A Quintero, MD University of South Florida
  More Information

Publications:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01622049     History of Changes
Other Study ID Numbers: #105118
Study First Received: August 5, 2010
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fetofetal Transfusion
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 23, 2014