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Main
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Note: This record shows only the 20 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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR982 |
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Date of registration:
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24/05/2007 |
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Primary sponsor: |
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Public title:
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Scar Evaluation after Caesarean by Ultrasound Registry
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Scientific title:
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Scar Evaluation after Caesarean by Ultrasound Registry - SECURE |
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Date of first enrolment:
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1/7/2007 |
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Target sample size:
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224 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=982 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.J.M.
Bij de Vaate |
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Address:
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Department of Obstetrics and Gynaecology
VU University Medical Center
De Boelelaan 1117
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31 20 4443613 |
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Email:
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m.bijdevaate@vumc.nl |
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Affiliation:
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Name:
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H.A.M.
Brölmann |
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Address:
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VU University Medical Center
De Boelelaan 1117
Amsterdam
The Netherlands |
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Telephone:
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+31 20 4444851 |
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Email:
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h.brolmann@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Caesarean delivery in the past history
2. Signed informed consent form
Exclusion criteria: 1. Pregnancy
2. Pelvic inflammatory disease
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Caesarean section, Niche, Uterine rupture, Abnormal uterine bleeding
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Intervention(s)
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Gel instillation sonohysterography is performed 6 to 12 months after caesarean section to detect a niche. Women are asked to fill in a questionnaire and keep a diary card to discover abnormal uterine bleeding.
In case of subsequent pregnancy, transvaginal ultrasound is performed to detect the presence of a niche and measure the thinnest zone of the lower uterus segment.
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Primary Outcome(s)
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1. A well circumscribed anatomical niche classification
2. A difference in uterine bleeding pattern between women with different niche types (based on the classification)
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Secondary Outcome(s)
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1. To demonstrate a relation between niche and LUS thickness;
2. To demonstrate an association between a. niche and (in)complete uterine rupture;
b. between LUS thickness and (in)complete uterine rupture.
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Secondary ID(s)
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ISRCTN39988897
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Source(s) of Monetary Support
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VU University Medical Center, Department of Obstetrics and Gynaecology
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