|- candidate number||9415|
|- NTR Number||NTR2887|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-mei-2011|
|- Secondary IDs||R-07.14a VCMO|
|- Public Title||Study to look after defects of the cesarean section scar with ultrasound and study for risk factors to develop a defect.|
|- Scientific Title||Sonohysterographic evaluation of caesarean scar defects and determination of risk factors.|
|- hypothesis||Scar defect may give complications on long term. Study is to investigate if the defect is detectable with ultrasound.|
|- Healt Condition(s) or Problem(s) studied||Cesarean scar defect , Caesarean section|
|- Inclusion criteria||1. Have had a cesarean section less than 12 weeks ago;|
2. Good understanding and use of Dutch language.
|- Exclusion criteria||1. < 18 year;|
2. Mutliple pregnancy;
3. Known uterusanomaly;
4. Pregnancy at time of ultrasound;
5. Pelvic inflammatoiry disease.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||27-jan-2008|
|- planned closingdate||1-sep-2012|
|- Target number of participants||350|
|- Interventions||1. 6-12 weeks postpartum transvaginal ultrasound and sonohysterography;|
2. Questionairy 6 weeks, 6, 12 and 24 months post partum.
|- Primary outcome||1. Incidence scar defect > 2 mm by sonohysterography;|
2. Risk factors for developing a scar defect.
|- Secondary outcome||1. 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.
|- Timepoints||1. (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 site||N/A|
|- status||inclusion 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 |
(Source(s) of Monetary or Material Support)
|Sint Antonius Ziekenhuis Nieuwegein|
|- Brief summary||A 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)|
|- RECORD||5-mei-2011 - 24-mei-2011|