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

This study is ongoing, but not recruiting participants.
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: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Gestational Diabetes
Glucose Intolerance
Type 2 Diabetes
Intrauterine Contraception
 Device: Mirena (Levonorgestrel IUD)
Device: Paragard (Copper IUD ) or Tubal Ligation
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Glucose tolerance at 12 months postpartum. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Levonorgestrel IUD Device: Mirena (Levonorgestrel IUD)
Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use
Other Name: Mirena IUD
Copper IUD or Tubal Ligation Device: Paragard (Copper IUD ) or Tubal Ligation
Copper IUD placed to provide contraception for up to 10 years
Other Name: Paragard IUD

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Postpartum women with gestational diabetes in the last pregnancy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022645

Locations
United States, Illinois
Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Society of Family Planning
Investigators
Principal Investigator: Jessica W Kiley, MD, MPH Northwestern Universeity
  More Information

No publications provided

Responsible Party: Jessica Kiley, Prinicipal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01022645     History of Changes
Other Study ID Numbers: STU00014472, SFP3-3
Study First Received: November 25, 2009
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Intrauterine device
Gestational diabetes
Postpartum contraception
Postpartum birth control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Hyperglycemia
Copper
Levonorgestrel
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 16, 2013