Contact information
Type
Scientific
Primary contact
Dr A.J.M. Bij de Vaate
ORCID ID
Contact details
Vrije University Medical Centre (VUMC)
Department of Obstetrics and Gynaecology
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 444 3613
m.bijdevaate@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SECURE
Study hypothesis
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
Ethics approval received from the medical ethics committee of Vrije University Medical Centre (METc VUmc) on the 4th September 2007 (ref: 2007/126).
Study design
Observational prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/07/2007
Overall trial end date
01/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Caesarean delivery in the past history
2. Signed informed consent form
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
224
Participant exclusion criteria
1. Pregnancy
2. Pelvic inflammatory disease
Recruitment start date
01/07/2007
Recruitment end date
01/07/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary