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CompletedNCT01022645Updated Nov 20, 2014

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

An observational study in Gestational Diabetes, Glucose Intolerance and Type 2 Diabetes, sponsored by Northwestern University. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-11-20.

Sponsored by Northwestern University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Ages
18 Years to 45 Years
Sex
Female
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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).

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Conditions studied

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

Keywords

  • Intrauterine device
  • Gestational diabetes
  • Postpartum contraception
  • Postpartum birth control
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In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 42 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Postpartum women with gestational diabetes in the last pregnancy

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (actual)

Groups and cohorts

  • Levonorgestrel IUD

    Device: Mirena (Levonorgestrel IUD)

  • Copper IUD or Tubal Ligation

    Device: Paragard (Copper IUD ) or Tubal Ligation

Interventions

  • DeviceMirena (Levonorgestrel IUD)

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

    Also known as: Mirena IUD

  • DeviceParagard (Copper IUD ) or Tubal Ligation

    Copper IUD placed to provide contraception for up to 10 years

    Also known as: Paragard IUD

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What researchers measure

Primary outcomes

  1. Glucose tolerance at 12 months postpartum.

    Time frame: 12 months

07

Study locations

1 site
  • Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01022645
Lead sponsor
Northwestern University
Collaborators
Society of Family Planning
Responsible party
Jessica Kiley (Prinicipal Investigator, Northwestern University) — Principal investigator
First posted
Dec 1, 2009
Start date
Nov 2009
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Nov 20, 2014

Study contacts

Jessica W Kiley, MD, MPH
principal investigator · Northwestern Universeity

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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