Topics

IUD Uterine Vascularization and Side Effects

2014-08-27 03:37:54 | BioPortfolio

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.

Description

Design We will perform a prospective (quasi-experimental) clinical trial. Patients/Methodology 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 cm/s. 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 08:00 and 10:00 a.m. 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 Fisher’s 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 (0,1 or >1) the independent variables. P-value < 0.05 was considered statistically significant. The power calculation before this study protocol required the inclusion of 19 patients for a Pß=80%.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Conditions

Healthy

Intervention

intra-uterine device (TCu 380A)

Location

Hospital de Clinicas de Porto Alegre
Porto Alegre
RGS
Brazil
90003051

Status

Completed

Source

Hospital de Clinicas de Porto Alegre

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:37:54-0400

Clinical Trials [1601 Associated Clinical Trials listed on BioPortfolio]

Use of an Intra Uterine Balloon to Prevent Recurrent Adhesions

Patients suffering of subfertility as a consequence of intra uterine adhesions could be treated with adhesiolysis by hysteroscopy. Post-operative recurrent adhesions could be developed. To...

Ultrasound Guided Intra-uterine Device Insertion

Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim t...

Uterine Scratching in Intra-Uterine Insemination

This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trime...

Non Touch Technique for IUD Insertion

The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.

Diffusion-weighted Cerebral MRI and Intra Uterine Growth Restriction.

The purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foe...

PubMed Articles [8204 Associated PubMed Articles listed on BioPortfolio]

Potential chances for natural fertility influence results of intrauterine inseminations.

Intra-uterine insemination (IUI) is widely used for different indications. The aim of the present study was to evaluate the efficiency of intra-uterine insemination as a function of indication and ori...

Reliability of a portable device for quantifying tone and stiffness of quadriceps femoris and patellar tendon at different knee flexion angles.

The reliability of MyotonPRO that can monitor the mechanical properties of tissues is still unclear. This study aimed to analyze the within-day inter-operator and between-day intra-operator reliabilit...

Uterine non-enzymatic antioxidant defence mechanisms (glutathione, vitamin C, copper and zinc) in diagnosis of canine pyometra.

The aim of the present study was to determine the concentrations of glutathione (GSH), vitamin C, copper (Cu) and zinc (Zn) in the uterine tissues in diagnosis of canine pyometra. Fourteen samples of ...

Complete non-puerperal uterine inversion caused by uterine hemangioma: A case report.

Uterine inversion is a rare postpartum complication. Non-puerperal uterine inversion is extremely rare. It mostly occurs with uterine tumors, especially leiomyoma. In most instances, the inversion may...

Impact of an intra-abdominal cooling device during open kidney transplantation in pigs.

Transplantation of kidneys from deceased donors is still associated with a high rate of postoperative renal dysfunction. During implantation into the recipient, the kidney rewarms. This second warm is...

Medical and Biotech [MESH] Definitions

Contraceptive devices placed high in the uterine fundus with a string extending from the device through the cervical as into the vagina. (UMDNS, 1999)

Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.

Inflation of a balloon catheter within the uterine cavity to control UTERINE HEMORRHAGE.

Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)

A technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure. It may be achieved by intra-aortic balloon, or by implanting a special pumping device in the chest, or externally by applying a negative pressure to the lower extremities during cardiac systole.

More From BioPortfolio on "IUD Uterine Vascularization and Side Effects"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial