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

NCT01022645 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2014-11-20

No results posted yet for this study

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).

Conditions

  • Gestational Diabetes
  • Glucose Intolerance
  • Type 2 Diabetes
  • Intrauterine Contraception

Interventions

DEVICE

Mirena (Levonorgestrel IUD)

Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use

DEVICE

Paragard (Copper IUD ) or Tubal Ligation

Copper IUD placed to provide contraception for up to 10 years

Sponsors & Collaborators

Principal Investigators

  • Jessica W Kiley, MD, MPH · Northwestern Universeity

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01022645 on ClinicalTrials.gov