Condition category
Urological and Genital Diseases
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
27/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/english/

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

Publication citations

Additional files

Editorial Notes