Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489463
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-19
Brief Title:
IUD Uterine Vascularization and Side Effects
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
The Effect of the Levonorgestrel-Releasing Intrauterine System and the Copper-Intrauterine Device TCu 380A on Subendometrial Microvascularization and Uterine Artery Blood Flow
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to evaluate the effect of the LNG-IUS and TCU 380A users on the sub-endometrial vascularization and the uterine artery blood flow using power Doppler analysis and ultrasonography pulsed color Doppler during the precise mid-luteal phase
Detailed Description:
Design We will perform a prospective quasi-experimental clinical trial PatientsMethodology We prospectively will enrolled consecutive patients who wants to use IUD LNG-IUS or TCU 380A We will evaluate the sub-endometrial blood flow using power Doppler analysis uterine artery blood flow using pulsatility and resistance index and endometrial thickness before IUD insertion and three months later
The inclusion criteria are 1 regularly menstruating women menstrual cycle varying between 24-35 days 2 Normal serum TSH FSH and prolactin levels as measured on day-3 and with less than 40 years Contraceptive pills or any kind of hormonal medication had not been taken for at least 3 months prior to the study and any intrauterine device had necessarily been removed at least 3 months earlier Patients will be allowed to not use non-steroidal anti-inflammatory drugs NSAID within 24 h prior to any examination
The exclusion criteria are pregnancy acute or chronic pelvic inflammatory disease menorrhagia for unknown reason copper allergy cervicitis dysplasia in the cervix or genital tumor All patients underwent a gynecological examination and had a Papanicolaou smear taken during the previous 12 months
All patients will be daily examined with US after the eighth day of the cycle and follicular development will be observed to confirm ovulation they are then examined in the mid-luteal phase 6-9 days after ovulation to obtain the power Doppler energy PDE measurement pulsatility index PI resistance index RI and endometrial thickness ET by ultrasound US scans The study was approved by the Ethical Committee of Hospital de Clinicas de Porto Alegre IRB equivalent 02-127 and informed consent was obtained from all patients
Patients will be allocated into 2 groups according to the IUD LNG-IUS group A or TCu 380A group B
Three months after the LNG-IUS group A or TCu 380A group B insertion also in the mid-luteal phase 6-9 days after ovulation confirmed by US all subjects repeated the same study protocol
The sonographic equipment that will be used consisted of a SONOACE 9900 Medison SA - Korea The PDE PI and RI will be performed on a transvaginal route The settings for Power Doppler sonography are standardized for the highest sensitivity in the absence of apparent noise using a high pass filter at 50 Hz pulsed repetition frequency at 750 Hz and moderate long persistence The lowest possible measurable velocity was below 5 cms The same investigator using the same equipment and parameters will performe the sonography assessments so as to eliminate any interobserver variation All exams were carried out between 0800 and 1000 am in order to avoid interference of the circadian rhythm 10
Power Doppler energy is classified into 5 categories according to the sub-endometrial signal area percentage I 10 II 10-25 III 25-50 IV 50-75 and V 75
Statistics Student t test is used for comparing age and body mass index BMI The Wilcoxon-Mann-Whitney WMW test is used to compare skewed data PI RI and ET whereas the Chi-Square test and Fishers exact test are used for categorical data PDE
We will use multiple logistic regression model to examine the association of the outcome PI variability before and after IUD insertion categorized in percentile 50 and IUD LNG-IUS or TCu 380A age years and parity 01 or 1 the independent variables P-value 005 was considered statistically significant The power calculation before this study protocol required the inclusion of 19 patients for a Pß80
The inclusion criteria are 1 regularly menstruating women menstrual cycle varying between 24-35 days 2 Normal serum TSH FSH and prolactin levels as measured on day-3 and with less than 40 years Contraceptive pills or any kind of hormonal medication had not been taken for at least 3 months prior to the study and any intrauterine device had necessarily been removed at least 3 months earlier Patients will be allowed to not use non-steroidal anti-inflammatory drugs NSAID within 24 h prior to any examination
The exclusion criteria are pregnancy acute or chronic pelvic inflammatory disease menorrhagia for unknown reason copper allergy cervicitis dysplasia in the cervix or genital tumor All patients underwent a gynecological examination and had a Papanicolaou smear taken during the previous 12 months
All patients will be daily examined with US after the eighth day of the cycle and follicular development will be observed to confirm ovulation they are then examined in the mid-luteal phase 6-9 days after ovulation to obtain the power Doppler energy PDE measurement pulsatility index PI resistance index RI and endometrial thickness ET by ultrasound US scans The study was approved by the Ethical Committee of Hospital de Clinicas de Porto Alegre IRB equivalent 02-127 and informed consent was obtained from all patients
Patients will be allocated into 2 groups according to the IUD LNG-IUS group A or TCu 380A group B
Three months after the LNG-IUS group A or TCu 380A group B insertion also in the mid-luteal phase 6-9 days after ovulation confirmed by US all subjects repeated the same study protocol
The sonographic equipment that will be used consisted of a SONOACE 9900 Medison SA - Korea The PDE PI and RI will be performed on a transvaginal route The settings for Power Doppler sonography are standardized for the highest sensitivity in the absence of apparent noise using a high pass filter at 50 Hz pulsed repetition frequency at 750 Hz and moderate long persistence The lowest possible measurable velocity was below 5 cms The same investigator using the same equipment and parameters will performe the sonography assessments so as to eliminate any interobserver variation All exams were carried out between 0800 and 1000 am in order to avoid interference of the circadian rhythm 10
Power Doppler energy is classified into 5 categories according to the sub-endometrial signal area percentage I 10 II 10-25 III 25-50 IV 50-75 and V 75
Statistics Student t test is used for comparing age and body mass index BMI The Wilcoxon-Mann-Whitney WMW test is used to compare skewed data PI RI and ET whereas the Chi-Square test and Fishers exact test are used for categorical data PDE
We will use multiple logistic regression model to examine the association of the outcome PI variability before and after IUD insertion categorized in percentile 50 and IUD LNG-IUS or TCu 380A age years and parity 01 or 1 the independent variables P-value 005 was considered statistically significant The power calculation before this study protocol required the inclusion of 19 patients for a Pß80
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None