The Randomised Uterine Septum Transsection Trial

Not Applicable

Recruiting

• Conditions: Septated Uterus.; Congenital malformation of uterus and cervix, unspecified

• Registration Number: IRCT2016112331052N1
• Lead Sponsor: Avicenna Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Infertile women who visited in Avicenna Research center and 6 medical centers in netherland ; The trial will include women with a septate uterus and an active wish to conceive. A septate uterus is defined as a uterus with a division (septum) of the uterine cavity, without any restrictions to the length of the septum. The external contour of the
uterus should not have an indentation; Having satiafaction about participating in this study . Exclusion criteria:Women with contraindication for surgery

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ive birth after 24 weeks pregnancy. Timepoint: Live birth at least 24 weeks of gestational age within one year after surgery. Method of measurement: Sonography and clinical visits and notes.

Secondary Outcome Measures

Name	Time	Method
terine perforation during intervetion. Timepoint: During hysteroscopic metroplasty of septated uterus. Method of measurement: Clinical findings,hysteroscopic findings,sonographic findings.;Abortion. Timepoint: Within one year of intervention. Method of measurement: Clinical findings.;Week of pregnancy that abortion occured. Timepoint: Within 1 years after intervention. Method of measurement: Week of pregnancy.;Uterine perforation in pregnancy after intervention. Timepoint: During pregnancy within one year of intervention. Method of measurement: Clinical findings.;Preterm labor. Timepoint: Within one year of intervention. Method of measurement: Weeks of pregnancy.;Clinical pregnancy. Timepoint: Within1 years after intervention. Method of measurement: Sonography.;Endometritis. Timepoint: Till 6 weeks after intervention. Method of measurement: Clinical findings.;Maternal death during pregnancy. Timepoint: Within one year after intervention. Method of measurement: Clinical findings.