Scar Evaluation after Caesarean by Ultrasound Registry
| ISRCTN | ISRCTN39988897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39988897 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 05/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.J.M. Bij de Vaate
Scientific
Scientific
Vrije University Medical Centre (VUMC)
Department of Obstetrics and Gynaecology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31 (0)20 444 3613 |
|---|---|
| m.bijdevaate@vumc.nl |
Study information
| Study design | Observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Scar Evaluation after Caesarean by Ultrasound Registry |
| Study acronym | SECURE |
| Study objectives | The primary hypothesis is that an association exists between the presence of a niche and abnormal uterine bleeding in women who had a previous caesarean section. |
| Ethics approval(s) | Ethics approval received from the medical ethics committee of Vrije University Medical Centre (METc VUmc) on the 4th September 2007 (ref: 2007/126). |
| Health condition(s) or problem(s) studied | Abnormal uterine bleeding, uterine rupture, caesarean section |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 1. A well circumscribed anatomical niche classification. The niches will be measured by ultrasound 6 - 12 months after caesarean section 2. A difference in uterine bleeding pattern between women with different niche types (based on the classification), with a follow-up of the bleeding pattern for 5 years after caesarean section |
| Secondary outcome measures | 1. To demonstrate a relation between niche and Lower Uterine Segment (LUS) thickness in case of a subsequent pregnancy. The LUS will be measured between 16 and 20 weeks gestation, and between 36 and 38 weeks gestation 2. To demonstrate an association between: 2.1. Niche and (in)complete uterine rupture 2.2. LUS thickness and (in)complete uterine rupture To identify an (in)complete rupture, the course of the pregnancy will be recorded |
| Overall study start date | 01/07/2007 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 224 |
| Total final enrolment | 225 |
| Key inclusion criteria | 1. Caesarean delivery in the past history 2. Signed informed consent form |
| Key exclusion criteria | 1. Pregnancy 2. Pelvic inflammatory disease |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
Vrije University Medical Centre (VUMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/01/2011 | 05/08/2021 | Yes | No |
Editorial Notes
05/08/2021: Publication reference and total final enrolment added.
