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

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, 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

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).

Keywords: Hysteroscopic septum resection; Randomised controlled trial; Recurrent miscarriage; Septate uterus; Subfertility.

Conflict of interest statement

Ethics approval and consent to participate

The TRUST study was approved by the Medical Ethical Committee of the Academic Medical Center Amsterdam at 28th of October 2008 (MEC 08/245). Written informed consent to participate in the study will be obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests, with the exception of:

A.L. Thurkow:

Member International Surgical Advisory Board for Gynaecology Olympus.

Member International Advisory Board for Energy Devices(Division of Ethicon inc., Johnson & Johnson).

Member Hologic International Advisory Board for minimal invasive procedures.

M.H. Emanuel:

Consultant and member medical advisory board Smith and Nephew Ltd.

Inventor and royalty receiver hysteroscopic morcellation Smith and Nephew Ltd.

Inventor and royalty receiver gel instillation sonohysterography GynaecologIQ BV.

S. Veersema:

Consultant at Bayer healthcare.

Member Hologic Advisory Board for minimal invasive procedures.

M.Y. Bongers:

Member Hologic Advisory Board for minimal invasive procedure

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Flowchart

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