The Randomised Uterine Septum Transsection Trial
Go to the TRUST website.
It is recognized that the prevalence of the septate uterus is increased in women with recurrent miscarriage (Homer et al, Fertil Steril 2000).
At present the finding of a septate uterus in women with recurrent miscarriage is not an indication for surgical correction of the septum. The role of hysteroscopic metroplasty in women affected by subfertility is being debated as well.
It is not known whether a septum should be removed in women with subfertility and/or recurrent miscarriage to improve reproductive outcome.
This study will answer the question whether surgical intervention (hysteroscopic metroplasty) in women with subfertility and/or recurrent miscarriage and a septate uterus will improve their reproductive outcome.
A multi centre randomised controlled trial.
68 women with recurrent miscarriages (two or more) before 20 weeks of gestational age and/or subfertility with a septate uterus.
Random allocation to hysteroscopic septoplasty or no intervention.
Outcome measures and analysis
Primary outcome is live birth rate in each treatment group.
Secondary outcomes are complications following metroplasty; uterine perforation, fluid overload, endometritis, clinical pregnancy and miscarriage. In a subsequent pregnancy, we will look at the prevalence of adversary pregnancy outcomes, placental abruption, premature delivery, uterine rupture, and mode of delivery (vaginal vs. caesarean section).
The analysis of the randomised clinical trial will be by intention to treat. The live birth rates in the intervention group and the control group will be compared. Relative risks and 95% confidence intervals will be calculated for the relevant outcome measures.
Academisch Medisch Centrum, Amsterdam
Spaarne Ziekenhuis, Hoofddorp
Canisius Wilhelmina Ziekenhuis, Nijmegen
Maxima Medisch Centrum, Veldhoven/ Eindhoven
Medisch Centrum Leeuwarden, Leeuwarden
M. Goddijn, gynaecoloog