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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01022645

Enrollment

Registered

2009-12-01

Start date

2009-11-30

Completion date

2014-08-31

Last updated

2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Intrauterine device, Gestational diabetes, Postpartum contraception, Postpartum birth control

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).

Interventions

DEVICEMirena (Levonorgestrel IUD)

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

DEVICEParagard (Copper IUD ) or Tubal Ligation

Copper IUD placed to provide contraception for up to 10 years

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Glucose tolerance at 12 months postpartum.	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026