NCT02733081

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

2.8 years

First QC Date

February 9, 2016

Last Update Submit

December 1, 2022

Conditions

Contraception

Keywords

Long Acting Reversible ContraceptionIntrauterine Device (IUD)Intrauterine Device (IUD) InsertionFamily PlanningInternational Family Planning

Outcome Measures

Primary Outcomes (1)

  • Correct IUD Placement Immediately Post-Insertion

    Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound.

    Immediately post-insertion

Secondary Outcomes (3)

  • Correct IUD Placements 4-6 Weeks Post-Insertion

    4-6 weeks post-insertion

  • Patient Satisfaction with IUD Insertion

    Immediately Post-Insertion

  • Patient Pain Scores (VAS)

    Immediately Post-Insertion

Study Arms (2)

Arm 1: Traditional IUD Insertion

NO INTERVENTION

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

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

Procedure: Simplified IUD Insertion

Interventions

Simplified IUD InsertionPROCEDURE

IUD Insertion with no bimanual pelvic exam or uterine sounding.

Arm 2: Simplified IUD Insertion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Tayal VS, Crean CA, Norton HJ, Schulz CJ, Bacalis KN, Bliss S. Prospective comparative trial of endovaginal sonographic bimanual examination versus traditional digital bimanual examination in nonpregnant women with lower abdominal pain with regard to body mass index classification. J Ultrasound Med. 2008 Aug;27(8):1171-7. doi: 10.7863/jum.2008.27.8.1171.

    PMID: 18645075BACKGROUND

  • Padilla LA, Radosevich DM, Milad MP. Limitations of the pelvic examination for evaluation of the female pelvic organs. Int J Gynaecol Obstet. 2005 Jan;88(1):84-8. doi: 10.1016/j.ijgo.2004.09.015.

    PMID: 15617719BACKGROUND

  • Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception. 2012 Sep;86(3):214-9. doi: 10.1016/j.contraception.2012.01.005. Epub 2012 Feb 9.

    PMID: 22325115BACKGROUND

  • Canteiro R, Bahamondes MV, dos Santos Fernandes A, Espejo-Arce X, Marchi NM, Bahamondes L. Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities. Contraception. 2010 Jun;81(6):515-9. doi: 10.1016/j.contraception.2010.01.006. Epub 2010 Mar 1.

    PMID: 20472119BACKGROUND

  • Bahamondes MV, Monteiro I, Canteiro R, Fernandes Ados S, Bahamondes L. Length of the endometrial cavity and intrauterine contraceptive device expulsion. Int J Gynaecol Obstet. 2011 Apr;113(1):50-3. doi: 10.1016/j.ijgo.2010.10.013. Epub 2011 Jan 26.

    PMID: 21272883BACKGROUND

  • Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.

    PMID: 25601352BACKGROUND

  • Christensen K, et al. Simplifying Insertion of IUD Devices. Selected for poster presentation at FIGO 2015, Vancouver British Columbia.

    BACKGROUND

  • ESHRE Capri Workshop Group. Intrauterine devices and intrauterine systems. Hum Reprod Update. 2008 May-Jun;14(3):197-208. doi: 10.1093/humupd/dmn003. Epub 2008 Apr 9.

    PMID: 18400840BACKGROUND

Study Officials

  • Paul D Blumenthal, MD, MPH

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2016

First Posted

April 11, 2016

Study Start

January 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

December 5, 2022

Record last verified: 2022-12