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

Completed

• Conditions: Glucose Intolerance; Intrauterine Contraception; Gestational Diabetes; Type 2 Diabetes
• Interventions: Device: Mirena (Levonorgestrel IUD); Device: Paragard (Copper IUD ) or Tubal Ligation

• Registration Number: NCT01022645
• Lead Sponsor: Northwestern University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Levonorgestrel IUD	Mirena (Levonorgestrel IUD)	-
Copper IUD or Tubal Ligation	Paragard (Copper IUD ) or Tubal Ligation	-

Primary Outcome Measures

Name	Time	Method
Glucose tolerance at 12 months postpartum.	12 months

Trial Locations

Locations (1)

Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States