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

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Jessica Kiley, Northwestern University
ClinicalTrials.gov Identifier:
NCT01022645
First received: November 25, 2009
Last updated: November 19, 2014
Last verified: November 2014

November 25, 2009
November 19, 2014
November 2009
August 2014   (final data collection date for primary outcome measure)
Glucose tolerance at 12 months postpartum. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Glucose tolerance at 12 months postpartum. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01022645 on ClinicalTrials.gov Archive Site
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Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes
Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study

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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Postpartum women with gestational diabetes in the last pregnancy

  • Gestational Diabetes
  • Glucose Intolerance
  • Type 2 Diabetes
  • Intrauterine Contraception
  • 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
  • Levonorgestrel IUD
    Intervention: Device: Mirena (Levonorgestrel IUD)
  • Copper IUD or Tubal Ligation
    Intervention: Device: Paragard (Copper IUD ) or Tubal Ligation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-45 years at the time of enrollment
  2. Single gestation in the current pregnancy
  3. GDM in the current pregnancy, diagnosed by 2- or 3-hour oral glucose tolerance test (OGTT) performed at 24-32 weeks gestation
  4. Desires intrauterine contraception or tubal ligation postpartum
  5. Willing and able to read and sign an informed consent form in English
  6. Willing to comply with the study protocol

Exclusion Criteria:

  1. History of pre-gestational DM, type 1 or 2
  2. Pregnancy conceived with assisted reproductive technologies
  3. Positive for human immunodeficiency virus (HIV) infection
  4. Desires repeat pregnancy within the first 12 months following delivery
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01022645
STU00014472, SFP3-3
No
Jessica Kiley, Northwestern University
Northwestern University
Society of Family Planning
Principal Investigator: Jessica W Kiley, MD, MPH Northwestern Universeity
Northwestern University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP