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

Type 2 Diabetes Clinical Trial

Official title:

Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022645
• Other study ID #: STU00014472
• Secondary ID: SFP3-3
• Status: Completed
• Phase: Phase 4
• First received: November 25, 2009
• Last updated: November 19, 2014
• Start date: November 2009
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Device:
• Mirena (Levonorgestrel IUD)
Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use
• Paragard (Copper IUD ) or Tubal Ligation
Copper IUD placed to provide contraception for up to 10 years

Locations

Country	Name	City	State
United States	Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance at 12 months postpartum.		12 months	No