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Резекция перегородки у женщин репродуктивного возраста с внутриматочной перегородкой

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Referencias

References to ongoing studies

Ir a:

ISRCTN28960271 {unpublished data only}

ISRCTN28960271. Pilot randomised controlled trial of hysteroscopic septal resection [Assessment of hysteroscopic metroplasty in women with a uterine septum and a history of miscarriage: a randomised controlled trial]. isrctn.com/ISRCTN28960271 (date applied 6 January 2015). CENTRAL

NTR1676 {unpublished data only}

NTR1676. The Randomised Uterine Septum Transsection Trial [The Randomised Uterine Septum Transsection Trial]. trialregister.nl/trialreg/admin/rctview.asp?TC=1676 (date registered 18 February 2009). CENTRAL

Additional references

Ir a:

Candiani 1983

Candiani GB, Fedele L, Zamberletti D, De Virgiliis D, Carinelli S. Endometrial patterns in malformed uteri. Acta Europaea Fertilitatis 1983;14(5):311‐8.

Chan 2011

Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine‐Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. [Review]. Ultrasound in Obstetrics & Gynecology 2011;38:371‐82.

Christiansen 2005

Christiansen OB, Nybo Andersen AM, Bosch E, Daya S, Delves PJ, Hvijd TV, et al. Evidence‐based investigations and treatments of recurrent pregnancy loss. Fertility and Sterility 2005;83(4):821‐39.

Edström 1970

Edström K, Fernström I. The diagnostic possibilities of a modified hysteroscopic technique. Acta Obstetricia et Gynecologica Scandinavica 1970;49:327‐30.

Fayez 1986

Fayez JA. Comparison between abdominal and hysteroscopic metroplasty. Obstetrics & Gynecology 1986;68:399‐403.

Gaucherand 1994

Gaucherand P, Awada A, Rudigoz RC, Dargent D. Obstetrical prognosis of the septate uterus: a plea for treatment of the septum. European Journal of Obstetrics & Gynecology and Reproductive Biology 1994;54(2):109‐12.

GRADEpro GDT 2014 [Computer program]

GRADE Working Group, McMaster University. GRADEpro GDT. Version Accessed prior to 26 October 2016. Hamilton (ON): GRADE Working Group, McMaster University, 2014.

Grimbizis 2013

Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, .De Angelis C, Gergolet M, et al. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Gynecological Surgery2013; Vol. 10, issue 3:199‐212.

Heinonen 1997

Heinonen PK. Reproductive performance of women with uterine anomalies after abdominal or hysteroscopic metroplasty or no surgical treatment. Journal of the American Association of Gynecologic Laparoscopists 1997;4(3):311‐7.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated 2011]. The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

Homer 2000

Homer HA, Li TC, Cooke ID. The septate uterus: a review of management and reproductive outcome. Fertility and Sterility 2000;73(1):1‐14.

Kirk 1993

Kirk EP, Chuong CJ, Coulam CB, Williams TJ. Pregnancy after metroplasty for uterine anomalies. Fertility and Sterility 1993;59(6):1164‐8.

Lin 2009

Lin K, Zhu X, Xu H, Liang Z, Zhang X. Reproductive outcome following resectoscope metroplasty in women having a complete uterine septum with double cervix and vagina. International Journal of Gynecology & Obstetrics 2009;105(1):25‐8.

Maneschi 1991

Maneschi F, Parlato M, Incandela S, Maneschi M. Reproductive performance in women with complete septate uteri. Journal of Reproductive Medicine 1991;36(10):741‐4.

March 1983

March CM. Hysteroscopy as an aid to diagnosis in female infertility. Clinical Obstetrics & Gynecology 1983;26:302‐12.

Mastenbroek 2006

Mastenbroek S, Twisk M, Goddijn M, Veen F, Repping S, Bossuyt PM, et al. PGD ‐ a model to evaluate efficacy?. Fertility and Sterility 2006;85:534.

Pang 2011

Pang LH, Li MJ, Li M, Xu H, Wei ZL. Not every subseptate uterus requires surgical correction to reduce poor reproductive outcome. International Journal of Gynecology & Obstetrics 2011;115:260‐3.

Paradisi 2014

Paradisi R, Barzanti R, Fabbri R. The techniques and outcomes of hysteroscopic metroplasty. Current Opinion in Obstetrics and Gynecology 2014;26:295‐301.

RevMan 2014 [Computer program]

The Cochrane Collaboration. Review Manager 5 (RevMan 5), Version 5.3. Copenhagen: Nordic Cochrane Centre: The Cochrane Collaboration, 2014.

Sparac 2001

Sparac V, Kupesic S, Ilijas M, Zodan T, Kurjak A. Histologic architecture and vascularization of hysteroscopically excised intrauterine septa. Journal of the American Association of Gynecologic Laparoscopists 2001;8(1):111‐6.

Sugiura‐Ogasawara 2013

Sugiura‐Ogasawara M, Ozaki Y, Suzumori N. Mullerian anomalies and recurrent miscarriage. [Review]. Current Opinion in Obstetrics & Gynecology 2013;25:293‐8.

Tonguc 2011

Tonguc EA, Var T, Batioglu S. Hysteroscopic metroplasty in patients with a uterine septum and otherwise unexplained infertility. International Journal of Gynecology & Obstetrics 2011;113(2):128‐30.

Vail 2003

Vail A, Gardener E. Common statistical errors in the design and analysis of subfertility trials. Human Reproduction 2003;18(5):1000‐4.

Valle 2013

Valle RF, Ekpo GE. Hysteroscopic metroplasty for the septate uterus: review and meta‐analysis. Journal of Minimally Invasive Gynecology 2013;20(1):22‐42.

Valli 2004

Valli E, Vaquero E, Lazzarin N, Caserta D, Marconi D, Zupi E. Hysteroscopic metroplasty improves gestational outcome in women with recurrent spontaneous abortion. Journal of the American Association of Gynecologic Laparoscopists 2004;11(2):240‐4.

Zreik 1998

Zreik TG, Troiano RN, Ghoussoub RAD, Olive DL, Arici A, McCarthy SM. Myometrial tissue in uterine septa. Journal of the American Association of Gynecologic Laparoscopists 1998;5(2):155‐60.

References to other published versions of this review

Ir a:

Kowalik 2011

Kowalik CR, Goddijn M, Emanuel MH, Bongers MY, Spinder T, de Kruif JH, et al. Metroplasty versus expectant management for women with recurrent miscarriage and a septate uterus. Cochrane Database of Systematic Reviews 2011, Issue 6. [DOI: 10.1002/14651858.CD008576.pub3]

Characteristics of studies

Characteristics of ongoing studies [ordered by study ID]

ISRCTN28960271

Trial name or title

Pilot randomised controlled trial of hysteroscopic septal resection

Methods

Randomised controlled trial

Participants

Women with septate uteri and a history of miscarriage or preterm birth

Interventions

Women will be randomised to septum resection or expectant management.

Outcomes

Primary outcome: live birth surviving until discharge from hospital

Secondary outcome measures:

  1. Uterine perforation

  2. Fluid overload

  3. Endometritis

  4. Bleeding

  5. Incomplete resection

  6. Synechiae or adhesions

  7. Clinical pregnancy rate

  8. Miscarriage (first or second trimester)

  9. Premature delivery (< 34 weeks and < 37 weeks)

  10. Ectopic pregnancy

  11. Uterine rupture

  12. Delivery (vaginal, elective or emergency )

  13. Postpartum haemorrhage (1500 mL)

  14. Placenta praevia

  15. Morbidly adherent placenta

Starting date

October 2013 (date of ethical approval)

Contact information

Matthew Prior: [email protected]

Notes

Pilot/feasibility RCT, so power calculation determined.

Currently 2 women have been included.

Protocol/serial number 13GY007
NTR1676

Trial name or title

TRUST (The Randomised Uterine Septum Transsection Trial)

Methods

Multicentre randomised controlled trial

Participants

Women with a septate uterus and a history of (recurrent) miscarriage, subfertility, or preterm birth

Interventions

Women will be randomised to septum resection or expectant management.

Outcomes

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 metroplasty.

Based on retrospective studies, an improvement in the live birth rate is anticipated from 35% without surgery to 70% with surgery.

Starting date

October 2008

Contact information

Judith Rikken: [email protected]

Notes

The sample size of this RCT is 68, and currently 43 women have been included. The expected final inclusion is December 2017.

RCT: randomised controlled trial

The ESHRE/ESGE classification system for female genital congenital anomalies (Grimbizis 2013).
Figuras y tablas -
Figure 1

The ESHRE/ESGE classification system for female genital congenital anomalies (Grimbizis 2013).

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Study flow diagram.
Figuras y tablas -
Figure 2

Study flow diagram.

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