Intrauterine Device (IUD) Placement at the Time of Cesarean Section

NCT ID: NCT00986089

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intrauterine Device Placement

Keywords

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post-placental IUD Copper IUD cesarean section immediate post-partum continuation

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duramed Research

INDUSTRY

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 17900440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6406171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17046378 (View on PubMed)

Other Identifiers

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08-0938-F6A

Identifier Type: -

Identifier Source: org_study_id