SMFM meeting paperA prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome
Section snippets
Study design
This trial was a 5 year multicenter, prospective, randomized, controlled trial to examine the effect of SFLP, compared with serial AR, on perinatal mortality in severe TTTS. Patients meeting entry criteria (see Table) and consenting to enter the trial were randomized to 1 of the 2 treatment arms with equal likelihood.
Primary and secondary outcomes
The primary outcome variable to be assessed in this trial comparing AR with SFLP was the 30 day neonatal survival of donors and recipients. In addition, secondary outcome variables
Results
The study was stopped early, after 42 subjects were randomized, at the request of the investigators. Referring physicians were increasingly unwilling to refer eligible subjects for evaluation to participating centers in which SFLP was available only through randomization in the trial. At the same time that the investigators’ meeting was held to decide to stop the trial, the Trial Oversight Committee, charged with evaluating all adverse events and serious adverse events, detected a statistical
Comment
The results of this trial show no statistically significant difference in overall neonatal survival to 30 days of life or neonatal survival of 1 or both twins in the same pregnancy in cases of severe TTTS treated by either AR or SFLP. Despite these overall results, there is a statistically significantly worse fetal survival observed among recipient twins in pregnancies treated by SFLP, compared with those treated by AR. This apparent conundrum can be accounted for by recipient fetal losses in
Acknowledgments
The authors gratefully acknowledge the expert technical assistance of the following:
The Children’s Hospital of Philadelphia
Victoria Shokrollah, MT, trial coordinator
Roberta Ballard, MD, consultant
Lori J. Howell, RN, MS, study coordinator
Jamie Koh, study coordinator
Joy Macdonald, RN, study coordinator
Joy N. Williams, RN, BSN, study coordinator
Cincinnati Children’s Hospital Medical Center
Kim Lyons, RN, BSN, CCRC, trial coordinator,
Jennifer L. Mason, RN, BSN, study coordinator
Columbia-Presbyterian
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This work was supported in part by Grant R01 HD41149 from the National Institute of Child Health and Human Development (to T.M.C.). Statistical work was supported in part by National Institute of Child Health and Human Development, Mental Retardation Developmental Disabilities Research Center at Children’s Hospital of Philadelphia, Grant 3P30 HD26979-04S2 (to D.S.).
Cite this article as: Crombleholme TM, Shera D, Lee H, et al. A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome. Am J Obstet Gynecol 2007;197:396.e1-396.e9.