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The randomised uterine septum transsection trial (TRUST): design and protocol.
Rikken, J F W; Kowalik, C R; Emanuel, M H; Bongers, M Y; Spinder, T; de Kruif, J H; Bloemenkamp, K W M; Jansen, F W; Veersema, S; Mulders, A G M G J; Thurkow, A L; Hald, K; Mohazzab, A; Khalaf, Y; Clark, T J; Farrugia, M; van Vliet, H A; Stephenson, M S; van der Veen, F; van Wely, M; Mol, B W J; Goddijn, M.
Afiliación
  • Rikken JFW; Center for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100, DE, Amsterdam, The Netherlands.
  • Kowalik CR; Center for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100, DE, Amsterdam, The Netherlands.
  • Emanuel MH; University Medical Center Utrecht, Heidelberglaan 100, 3584, Utrecht, The Netherlands.
  • Bongers MY; Maxima Medical Centre, de Run 4600, 5504, DB, Veldhoven, The Netherlands.
  • Spinder T; Leeuwarden Medical Centre, Henri Dunantweg 2, 8934, AD, Leeuwarden, the Netherlands.
  • de Kruif JH; Canisius Wilhelmina Hospital, PO Box 9015, 6500, GS, Nijmegen, The Netherlands.
  • Bloemenkamp KWM; University Medical Center Utrecht, Heidelberglaan 100, 3584, Utrecht, The Netherlands.
  • Jansen FW; University Medical Centre Leiden, Albinusdreef 2, 2333, ZA, Leiden, The Netherlands.
  • Veersema S; University Medical Center Utrecht, Heidelberglaan 100, 3584, Utrecht, The Netherlands.
  • Mulders AGMGJ; Erasmus Medical Centre, 's-Gravendijkwal 230, 3015, CE, Rotterdam, The Netherlands.
  • Thurkow AL; Center for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100, DE, Amsterdam, The Netherlands.
  • Hald K; Oslo University Hospital, P. O. Box 4950, Nydalen, N-0424, Oslo, Norway.
  • Mohazzab A; Avicenna research institute Teheran, PO Box: 19615-1177, Teheran, Postal code: 1936773493, Iran.
  • Khalaf Y; Guy's hospital, Great maze pond, London, SE1 9RT, UK.
  • Clark TJ; Birmingham women's hospital, Mindelsohn Way, Birmingham, West Midlands, B15 2TG, UK.
  • Farrugia M; East Kent Hospitals University, Ethelbert road, Canterbury, Kent, CT1 3NG, UK.
  • van Vliet HA; Catharina hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.
  • Stephenson MS; University of Illinois Hospital, 1740 W Taylor St, Chicago, IL, 60612, USA.
  • van der Veen F; Center for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100, DE, Amsterdam, The Netherlands.
  • van Wely M; Center for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100, DE, Amsterdam, The Netherlands.
  • Mol BWJ; The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
  • Goddijn M; Center for Reproductive Medicine, Academic Medical Centre, University of Amsterdam, PO Box 22700, 1100, DE, Amsterdam, The Netherlands. m.goddijn@amc.uva.nl.
BMC Womens Health ; 18(1): 163, 2018 10 05.
Article en En | MEDLINE | ID: mdl-30290803
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).
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Anomalías Urogenitales / Útero / Histeroscopía / Aborto Habitual / Infertilidad Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: BMC Womens Health Asunto de la revista: SAUDE DA MULHER Año: 2018 Tipo del documento: Article País de afiliación: Países Bajos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Anomalías Urogenitales / Útero / Histeroscopía / Aborto Habitual / Infertilidad Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: BMC Womens Health Asunto de la revista: SAUDE DA MULHER Año: 2018 Tipo del documento: Article País de afiliación: Países Bajos