Simplified IUD Insertion Technique (SIIT)

Stanford University

Status: Withdrawn

Conditions: Contraception

Treatments: Procedure: Simplified IUD Insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT02733081

IRB-35138

Details and patient eligibility

About

This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent.

Exclusion criteria

• Known contradictions to copper IUD, inability to comply with study protocol

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm 1: Traditional IUD Insertion

No Intervention group

Description:

Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion.

Arm 2: Simplified IUD Insertion

Experimental group

Description:

Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding.

Treatment:

Procedure: Simplified IUD Insertion