Scar Evaluation after Caesarean by Ultrasound Registry

ISRCTN	ISRCTN39988897
DOI	https://doi.org/10.1186/ISRCTN39988897
Protocol serial number	N/A
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	Vrije University Medical Centre (VUMC) (The Netherlands)

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

Vrije University Medical Centre (VUMC)
Department of Obstetrics and Gynaecology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 (0)20 444 3613
Email	m.bijdevaate@vumc.nl

Study information

Primary study design	Observational
Study design	Observational prospective cohort study
Secondary study design	Cohort study
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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/07/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.