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

Completed

Conditions studied: Gestational Diabetes, Glucose Intolerance, Type 2 Diabetes, Intrauterine Contraception

In brief

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).

Key facts

Study ID

NCT01022645

Run by

Northwestern University

People needed

42

Starts

2009-11-01

Expected to finish

2014-08-01

Last updated by the study team

2014-11-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-45 years at the time of enrollment
• Single gestation in the current pregnancy
• GDM in the current pregnancy, diagnosed by 2- or 3-hour oral glucose tolerance test (OGTT) performed at 24-32 weeks gestation
• Desires intrauterine contraception or tubal ligation postpartum
• Willing and able to read and sign an informed consent form in English
• Willing to comply with the study protocol

You may not qualify if…

• History of pre-gestational DM, type 1 or 2
• Pregnancy conceived with assisted reproductive technologies
• Positive for human immunodeficiency virus (HIV) infection
• Desires repeat pregnancy within the first 12 months following delivery

Where it is running

• Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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