NCT00733278

Brief Summary

This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

August 11, 2014

Completed
Last Updated

August 11, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

August 11, 2008

Results QC Date

October 8, 2013

Last Update Submit

July 16, 2014

Conditions

Contraception

Keywords

Postpartum contraceptionCopper IUD

Outcome Measures

Primary Outcomes (1)

  • Successful Retention of IUD

    6 weeks

Secondary Outcomes (1)

  • Visibility Within the Vagina of IUD Strings at All Times.

    At 3 days, 2 weeks and 6 weeks postpartum

Study Arms (1)

Copper IUD

EXPERIMENTAL

Copper IUD

Device: Copper IUD ( ParaGard Intrauterine Contraceptive Device)

Interventions

Copper IUD ( ParaGard Intrauterine Contraceptive Device)DEVICE

Intraoperative placement of copper IUD at time of C-section

Also known as: ParaGard Intrauterine Contraceptive Device
Copper IUD

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant woman
  • Requires elective C-section
  • Desires long-term contraception

You may not qualify if:

  • Contraindications to copper IUD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles BRI

Torrance, California, 90502, United States

Location

Limitations and Caveats

Pilot study involving only seven subjects, which limits generalizability of findings.

Results Point of Contact

Title
Dr. Anita Nelson
Organization
LA BioMed
anitanelsonwhc@earthlink.net

Study Officials

  • Anita L Nelson, MD

    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 11, 2014

Results First Posted

August 11, 2014

Record last verified: 2014-07

Locations

US(1)