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Trial record 2 of 7 for:    Recruiting Studies | ttts

Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

This study is currently recruiting participants.
Verified March 2017 by Ramen Chmait, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT02122328
First Posted: April 24, 2014
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ramen Chmait, University of Southern California
April 16, 2014
April 24, 2014
March 13, 2017
June 2010
February 2019   (Final data collection date for primary outcome measure)
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV. [ Time Frame: Birth ]
A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure.
Same as current
Complete list of historical versions of study NCT02122328 on ClinicalTrials.gov Archive Site
Surgical complications [ Time Frame: 21 post-operative days ]
Same as current
Fetal/neonatal/infant outcomes [ Time Frame: Birth to 6 months of life ]
Same as current
 
Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Twin Twin Transfusion Syndrome
  • Procedure: Sequential laser photocoagulation of communicating vessels.
  • Procedure: Selective laser photocoagulation of communicating vessels
  • Active Comparator: Selective procedure
    Selective laser photocoagulation of communicating vessels.
    Intervention: Procedure: Selective laser photocoagulation of communicating vessels
  • Experimental: Sequential procedure
    Sequential laser photocoagulation of communicating vessels
    Intervention: Procedure: Sequential laser photocoagulation of communicating vessels.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
542
February 2020
February 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.
  • Confirmed TTTS patients, who by definition meet the following sonographic criteria:

    • Single placenta.
    • Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage.
    • Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage.
    • Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic).
    • Same gender, if visible.
    • Quintero Stages 1-4.
  • Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included.
  • Patients with an anterior placenta may be included.
  • Triplet gestations with two or three fetuses sharing the same placenta may be included.
  • Patients must be able to give written informed consent.

Exclusion Criteria:

  • Patients unable or unwilling to participate in the study or to be followed up.
  • Patients unable to give written informed consent.
  • Presence of major congenital anomalies that may not warrant surgery.
  • Known unbalanced chromosomal complement.
  • Prior intentional septostomy (purposely making a hole in the dividing membrane).
  • Ruptured membranes.
  • Chorioamnionitis.
  • 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 as exclusion criteria.
  • Placental abruption.
  • Active labor.
  • Patient unwilling to receive blood products.
  • Recipient twin with a middle cerebral artery peak systolic velocity > 1.5 multiples of the median (indicative of fetal anemia).
  • Any other patient deemed inappropriate for the study by the principal investigator.
Sexes Eligible for Study: Female
16 Years to 55 Years   (Child, Adult)
Yes
Contact: Ramen Chmait, MD 626-356-3360 chmait@usc.edu
Contact: Arlyn Llanes, RN 626-356-3365 allanes@usc.edu
United States
 
 
NCT02122328
HS-09-00680
Yes
Not Provided
Not Provided
Ramen Chmait, University of Southern California
University of Southern California
Not Provided
Principal Investigator: Ramen Chmait, MD University of Southern California
University of Southern California
March 2017

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