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BMC Women's Health
Published in: BMC Women's Health 1/2018

Open Access 01-12-2018 | Study protocol

The randomised uterine septum transsection trial (TRUST): design and protocol

Authors: J. F. W. Rikken, C. R. Kowalik, M. H. Emanuel, M. Y. Bongers, T. Spinder, J. H. de Kruif, K. W. M. Bloemenkamp, F. W. Jansen, S. Veersema, A. G. M. G. J. Mulders, A. L. Thurkow, K. Hald, A. Mohazzab, Y. Khalaf, T. J. Clark, M. Farrugia, H. A. van Vliet, M. S. Stephenson, F. van der Veen, M. van Wely, B. W. J. Mol, M. Goddijn

Published in: BMC Women's Health | Issue 1/2018

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Abstract

Background

A septate uterus is a uterine anomaly that may affect reproductive outcome, and is associated with an increased risk for miscarriage, subfertility and preterm birth. Resection of the septum is subject of debate. There is no convincing evidence concerning its effectiveness and safety. This study aims to assess whether hysteroscopic septum resection improves reproductive outcome in women with a septate uterus.

Methods/design

A multi-centre randomised controlled trial comparing hysteroscopic septum resection and expectant management in women with recurrent miscarriage or subfertility and diagnosed with a septate uterus. The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage and complications following hysteroscopic septum resection. The analysis will be performed according to the intention to treat principle. Kaplan-Meier curves will be constructed, estimating the cumulative probability of conception leading to live birth rate over time. Based on retrospective studies, we anticipate an improvement of the live birth rate from 35% without surgery to 70% with surgery. To demonstrate this difference, 68 women need to be randomised.

Discussion

Hysteroscopic septum resection is worldwide considered as a standard procedure in women with a septate uterus. Solid evidence for this recommendation is lacking and data from randomised trials is urgently needed.

Trial registration

Dutch trial registry (NTR1676, 18th of February 2009).
Appendix
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Metadata
Title
The randomised uterine septum transsection trial (TRUST): design and protocol
Authors
J. F. W. Rikken
C. R. Kowalik
M. H. Emanuel
M. Y. Bongers
T. Spinder
J. H. de Kruif
K. W. M. Bloemenkamp
F. W. Jansen
S. Veersema
A. G. M. G. J. Mulders
A. L. Thurkow
K. Hald
A. Mohazzab
Y. Khalaf
T. J. Clark
M. Farrugia
H. A. van Vliet
M. S. Stephenson
F. van der Veen
M. van Wely
B. W. J. Mol
M. Goddijn
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Women's Health / Issue 1/2018
Electronic ISSN: 1472-6874
DOI
https://doi.org/10.1186/s12905-018-0637-6

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