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

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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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Intrauterine Contraception Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Type 2 Diabetes Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mirena (Levonorgestrel IUD)

Device

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

Other names: Mirena IUD

Paragard (Copper IUD ) or Tubal Ligation

Device

Copper IUD placed to provide contraception for up to 10 years

Other names: Paragard IUD

Primary outcomes

Glucose tolerance at 12 months postpartum.

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

Society of Family Planning

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Dec 1, 2009
Registry last updated: Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed