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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN28960271 |
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Date of registration:
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27/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot randomised controlled trial of hysteroscopic septal resection
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Scientific title:
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Assessment of hysteroscopic metroplasty in women with a uterine septum and a history of miscarriage: a randomised controlled trial |
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Date of first enrolment:
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09/12/2015 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN28960271 |
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Study type:
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Interventional |
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Study design:
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Pilot multi-centre randomised controlled trial to assess feasibility for a larger adequately powered trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Matthew
Prior |
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Address:
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Nurture Fertility
B Floor
East Block
Nottingham University Hospitals NHS Trust
Queen's Medical Centre Campus
Derby Road
NG7 2UH
Nottingham
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Uterine septum diagnosed with three-dimensional ultrasound
2. Aged at least 18 years old
3. Desire to conceive
4. History of one or more miscarriages (regardless of previous viable or live births
5. No previous surgery on the uterus or endometrial cavity
6. Body-mass index of 40 kg/m² or less
Added 06/08/2015:
7. Women with infertility
Exclusion criteria: 1. Other uterine anomalies apart from septum
2. Age younger than 18 years old
3. Not planning to become pregnant
4. Currently pregnant
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Women with septate uteri, a history of miscarriage or preterm birth, or infertility
Pregnancy and Childbirth
Uterine septum
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Intervention(s)
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1. Hysteroscopic septal resection
2. No intervention
All patients will be followed up in the same way.
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Primary Outcome(s)
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Live birth surviving until discharge from hospital
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Secondary Outcome(s)
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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. Post-partum haemorrhage (1500 mL)
14. Placenta praevia
15. Morbidly adherent placenta
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Source(s) of Monetary Support
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Nottingham University Hospitals Charity (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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