NCT00986089

Brief Summary

To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.

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 Aug 2008

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withdrawn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

Study Start

First participant enrolled

August 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

December 22, 2016

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

September 25, 2009

Last Update Submit

December 20, 2016

Conditions

Intrauterine Device Placement

Keywords

post-placentalIUDCopper IUDcesarean sectionimmediate post-partumcontinuation

Outcome Measures

Primary Outcomes (1)

  • Continuation at one year

    1 year

Secondary Outcomes (2)

  • satisfaction with placement at time of cesarean

    4-6 months and 1 year

  • bleeding profile

    6 months

Study Arms (1)

women who have an IUD placed at the time of c-section

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women ages 18-40 who are undergoing a scheduled cesarean section, or women who are attempting to VBAC and want an IUD post partum will be eligible.

You may qualify if:

  • Desire an IUD post-partum and are willing to use the copper IUD.
  • They will also need to be patients at one of our OBGYN clinics at the university of Kentucky.

You may not qualify if:

  • Post-partum hemorrhage,
  • Chorioamnionitis (or a fever \>101 at the time of cesarean),
  • Women on antibiotic or immunosuppressive therapies,
  • Cervical dilation \> 5 cm at the time of c-section, OR
  • Excessive intraoperative blood loss.
  • Also women with contraindications to a copper IUD: Wilson's disease, unusual uterine shape or known uterine anomaly.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007 Oct;76(4):292-6. doi: 10.1016/j.contraception.2007.06.003. Epub 2007 Aug 6.

    PMID: 17900440BACKGROUND

  • Liu BH, Zhang LY, Zhang BR. Intrauterine contraceptive device insertion with suture fixation at cesarean section. Chin Med J (Engl). 1983 Feb;96(2):141-4.

    PMID: 6406171BACKGROUND

  • Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.

    PMID: 17046378BACKGROUND
0

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 29, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 22, 2016

Record last verified: 2013-08