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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by University of Kentucky.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Duramed Research

Information provided by:

University of Kentucky

ClinicalTrials.gov Identifier:

NCT00986089

First received: September 25, 2009

Last updated: September 28, 2009

Last verified: September 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	September 25, 2009
Last Updated Date	September 28, 2009
Start Date ^ICMJE	October 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 28, 2009)	Continuation at one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00986089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 28, 2009)	satisfaction with placement at time of cesarean [ Time Frame: 4-6 months and 1 year ] [ Designated as safety issue: No ] bleeding profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intrauterine Device (IUD) Placement at the Time of Cesarean Section
Official Title ^ICMJE	Pilot Study of Copper IUD Placement at the Time of Cesarean Section
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-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.
Condition ^ICMJE	Intrauterine Device Placement
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	women who have an IUD placed at the time of c-section
Publications *	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. Epub 2007 Aug 6. 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. Ero?lu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Ta?kin 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. Epub 2006 Sep 15.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00986089
Other Study ID Numbers ^ICMJE	08-0938-F6A
Has Data Monitoring Committee	Not Provided
Responsible Party	Kristine Lain, MD, University of Kentucky
Study Sponsor ^ICMJE	University of Kentucky
Collaborators ^ICMJE	Duramed Research
Investigators ^ICMJE	Not Provided
Information Provided By	University of Kentucky
Verification Date	September 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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