A Novel IUD Insertion Technique

Woman's Health University Hospital, Egypt

Status: Unknown

Conditions: Contraception

Treatments: Device: intrauterine device TCu 380A; Radiation: Trans-abdominal sonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02582268

CU151020

Details and patient eligibility

About

A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females desiring contraception with the use of IUD
• Females with history of previous vaginal delivery

Exclusion criteria

• Are pregnant or think they may be pregnant
• Septic pregnancy or abortion
• Have unexplained abnormal vaginal bleeding
• Have untreated cervical cancer
• Have malignant gestational trophoblastic disease
• Have uterine cancer
• Have uterine abnormalities
• Have or may have had a pelvic infection within the past three months
• Have or may have any sexually transmitted disease
• Have pelvic tuberculosis
• Are postpartum between 48 hours and 4 weeks
• Have benign gestational trophoblastic disease

Trial design

100 participants in 2 patient groups

TAS guided IUD insertion

Experimental group

Description:

the female will be asked to be full bladder. the trans-abdominal probe will be placed by an assistant on the suprapubic region. under speculum examination, the intrauterine device IUD (TCu 380A) will be placed till it reaches the fundus of the uterus and then released.

Treatment:

Radiation: Trans-abdominal sonography

Device: intrauterine device TCu 380A

Traditional IUD insertion

Experimental group

Description:

the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. the trans-abdominal probe will also be placed by an assistant on the suprapubic region ( the image would be on freeze mode) as it is not actually used , it is just to make the same settings for the participant females.

Treatment:

Device: intrauterine device TCu 380A