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Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion

A

Assiut University

Status

Completed

Conditions

Contraception

Treatments

Radiation: Transvaginal ultrasound
Device: Cu-IUD
Procedure: Uterine sounding sparing group
Procedure: Classic group

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.

The fear and the pain associated with intrauterine devices insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.

The pain during intrauterine devices insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the intrauterine devices through the cervix, and irritation of the endometrial lining by the intrauterine devices .

Previous studies have reported different lines to decrease pain during intrauterine device insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or intrauterine lidocaine and misoprostol up to paracervical blocks.

Previous studies, in literature, have found that the most painful steps during intrauterine devices insertion were uterine sounding then intrauterine device insertion itself, followed by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum and a single-tooth tenaculum on pain perception during intrauterine devices and found no difference in reported pain.

Enrollment

92 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women requesting intrauterine contraceptive device as a contraction

Exclusion criteria

  • Uterine abnormalities
  • Endometrial lesions,
  • Adenomyosis
  • Fibroids
  • Intrauterine adhesions.
  • Chronic pelvic pain
  • Spasmodic dysmenorrhea
  • History of cervical surgery

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

92 participants in 2 patient groups

Group I (classic method)
Active Comparator group
Treatment:
Device: Cu-IUD
Procedure: Classic group
uterine sound sparing group
Active Comparator group
Treatment:
Procedure: Uterine sounding sparing group
Radiation: Transvaginal ultrasound
Device: Cu-IUD
Procedure: Classic group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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