Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding: effect on specimen quality
| ISRCTN | ISRCTN43875039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43875039 |
| 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
- 28/10/2021
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single blinded, controlled, parallel group single centre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Endometrial aspiration before or after Saline Infusion Sonography (SIS) in case of abnormal uterine bleeding: effect on specimen quality |
| Study acronym | Endometrial aspiration specimen quality after SIS |
| Study objectives | The specimen contains less evaluable endometrium after Saline Infusion Sonography (SIS) than before SIS. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee (METc VUmc) on the 7th September 2005 (ref: 2005/46). |
| Health condition(s) or problem(s) studied | Abnormal uterine bleeding, Saline Infusion Sonography (SIS), endometrial aspiration |
| Intervention | Saline Infusion Sonography (SIS) and endometrial aspiration are performed with the same catheter in one session. Patients are either allocated to aspiration and subsequent SIS, or to the reverse order. |
| Intervention type | Other |
| Primary outcome measure(s) |
Quality assessment of aspiration specimen by pathologist. Evaluation of the biopsy was performed by the pathologist immediately after taking the endometrial biopsy. |
| Key secondary outcome measure(s) |
Reliability of video SIS-images. The SIS was performed in the same session and was recorded on video. |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Total final enrolment | 113 |
| Key inclusion criteria | Patients with abnormal uterine bleeding. |
| Key exclusion criteria | 1. Pelvic Inflammatory Disease (PID) 2. Cervical cancer |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1081 HV
Netherlands
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/04/2008 | 28/10/2021 | Yes | No |
Editorial Notes
28/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
