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Study to look after defects of the cesarean section scar with ultrasound and study for risk factors to develop a defect.


- candidate number9415
- NTR NumberNTR2887
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mei-2011
- Secondary IDsR-07.14a  VCMO
- Public TitleStudy to look after defects of the cesarean section scar with ultrasound and study for risk factors to develop a defect.
- Scientific TitleSonohysterographic evaluation of caesarean scar defects and determination of risk factors.
- ACRONYMSCAR
- hypothesisScar defect may give complications on long term. Study is to investigate if the defect is detectable with ultrasound.
- Healt Condition(s) or Problem(s) studiedCesarean scar defect , Caesarean section
- Inclusion criteria1. Have had a cesarean section less than 12 weeks ago;
2. Good understanding and use of Dutch language.
- Exclusion criteria1. < 18 year;
2. Mutliple pregnancy;
3. Known uterusanomaly;
4. Pregnancy at time of ultrasound;
5. Pelvic inflammatoiry disease.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 27-jan-2008
- planned closingdate1-sep-2012
- Target number of participants350
- Interventions1. 6-12 weeks postpartum transvaginal ultrasound and sonohysterography;
2. Questionairy 6 weeks, 6, 12 and 24 months post partum.
- Primary outcome1. Incidence scar defect > 2 mm by sonohysterography;
2. Risk factors for developing a scar defect.
- Secondary outcome1. Relation with bleeding disorders (menstruation longer than 10 days, post menstrual spotting, intermenstrual bleeding);
2. Differences in ultrasound (depht of defect) within one patient in longitudinal follow-up of primipara;
3. Relation with urinary incontinence measured by questionary.
- Timepoints1. (Sono)hysterography 6-12 weeks post partum;
2. Questionairy 6 weeks, 6, 12 and 24 months post partum;
3. (Sono)hysterography 6-12 months post partum (primipara).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES S. Veersema
- CONTACT for SCIENTIFIC QUERIES L. Voet, van der
- Sponsor/Initiator Sint Antonius Ziekenhuis Nieuwegein , Department of gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Sint Antonius Ziekenhuis Nieuwegein
- PublicationsN/A
- Brief summaryA prospective cohort study to investigate the incidence and risk factors for developing a cesarean scar defect. This is done by (sono)hysterography 6-12 weeks post partum and a questionair 6 weeks, 6 ,12 and 24 months post partum. Secondary outcome is to study the relation with bleeding disorders (prolonged menstruation and postmenstrual spotting). We also look longitudinal within a patient to study the appareances of the scardefect in time.
- Main changes (audit trail)
- RECORD5-mei-2011 - 24-mei-2011


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