Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes

Tracking Information
First Submitted Date	November 25, 2009
First Posted Date	December 1, 2009
Last Update Posted Date	November 20, 2014
Study Start Date	November 2009
Actual Primary Completion Date	August 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 30, 2009)	Glucose tolerance at 12 months postpartum. [ Time Frame: 12 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01022645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes
Official Title	Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study
Brief Summary	The study is being done in order to gain information on the most suitable types of birth control in women who recently had gestational diabetes, or diabetes diagnosed during pregnancy. The intrauterine device (IUD) is a highly effective form of birth control. It is inserted into the uterus and prevents pregnancy for either 5 or 10 years, depending on the type of IUD (hormone-releasing or copper). The hormone-releasing IUD works for 5 years and releases a hormone called a progestin into the uterus. The copper IUD contains no hormones and works for 10 years. The IUD is an excellent form of birth control postpartum, but it is unknown if the hormone-releasing IUD will affect blood sugars and increase a woman's risk of becoming diabetic when she's not pregnant. The hypothesis is that the hormone-containing IUD will NOT increase blood sugars, so women who use the hormone-containing IUD will have similar blood sugars to those who use the copper IUD or have had their tubes tied (no hormones).
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Postpartum women with gestational diabetes in the last pregnancy
Condition	Gestational Diabetes; Glucose Intolerance; Type 2 Diabetes; Intrauterine Contraception
Intervention	Device: Mirena (Levonorgestrel IUD) Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use Other Name: Mirena IUD; Device: Paragard (Copper IUD ) or Tubal Ligation Copper IUD placed to provide contraception for up to 10 years Other Name: Paragard IUD
Study Groups/Cohorts	Levonorgestrel IUD Intervention: Device: Mirena (Levonorgestrel IUD); Copper IUD or Tubal Ligation Intervention: Device: Paragard (Copper IUD ) or Tubal Ligation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 19, 2014)	42
Original Estimated Enrollment; (submitted: November 30, 2009)	72
Actual Study Completion Date	August 2014
Actual Primary Completion Date	August 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Age 18-45 years at the time of enrollment; Single gestation in the current pregnancy; GDM in the current pregnancy, diagnosed by 2- or 3-hour oral glucose tolerance test (OGTT) performed at 24-32 weeks gestation; Desires intrauterine contraception or tubal ligation postpartum; Willing and able to read and sign an informed consent form in English; Willing to comply with the study protocol Exclusion Criteria: History of pre-gestational DM, type 1 or 2; Pregnancy conceived with assisted reproductive technologies; Positive for human immunodeficiency virus (HIV) infection; Desires repeat pregnancy within the first 12 months following delivery
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01022645
Other Study ID Numbers	STU00014472; SFP3-3
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jessica Kiley, Northwestern University
Study Sponsor	Northwestern University
Collaborators	Society of Family Planning
Investigators	Principal Investigator: Jessica W Kiley, MD, MPH Northwestern Universeity
PRS Account	Northwestern University
Verification Date	November 2014