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TRUST

 

The Randomised Uterine Septum Transsection Trial

 

Go to the TRUST website.

 

Background

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.

 

Objective

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.

 

Study design

A multi centre randomised controlled trial.

 

Study population

68 women with recurrent miscarriages (two or more) before 20 weeks of gestational age and/or subfertility with a septate uterus.

 

Intervention

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.

 

Participating hospitals

Academisch Medisch Centrum, Amsterdam

Spaarne Ziekenhuis, Hoofddorp

Canisius Wilhelmina Ziekenhuis, Nijmegen

Maxima Medisch Centrum, Veldhoven/ Eindhoven

Medisch Centrum Leeuwarden, Leeuwarden

 

Contact

M. Goddijn, gynaecoloog
AMC Q3-120
Meibergdreef 9
1100 DD Amsterdam
tel 020-5663557
M.Goddijn@amc.uva.nl