A Novel IUD Insertion Technique

NCT02582268 | Unknown DMC

• 1 other identifier: CU151020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• degree of pain during IUD insertion

  Pain will be assessed by the use of visual analog scale (VAS).

  4 months

Study Arms (2)

TAS guided IUD insertion

EXPERIMENTAL

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.

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

Traditional IUD insertion

EXPERIMENTAL

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.

Device: intrauterine device TCu 380A

Interventions

intrauterine device TCu 380A DEVICE

Also known as: TCu 380A

TAS guided IUD insertion; Traditional IUD insertion

Trans-abdominal sonography RADIATION

Also known as: TAS

TAS guided IUD insertion

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, 12211, Egypt

RECRUITING

Related Publications (1)

• Dakhly DMR, Bassiouny YA. Ultrasound-guided intrauterine device insertion: a step closer to painless insertion: a randomized control trial. Eur J Contracept Reprod Health Care. 2017 Oct;22(5):349-353. doi: 10.1080/13625187.2017.1381234. Epub 2017 Oct 5.

  PMID: 28978240 DERIVED

Study Officials

• Dina M Dakhly, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Dakhly, MD

CONTACT

01003498919; dinadakhly@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

EG (1)