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

NCT ID: NCT01022645

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-08-31

Brief Summary

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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

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Conditions

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Gestational Diabetes Glucose Intolerance Type 2 Diabetes Intrauterine Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Levonorgestrel IUD

Mirena (Levonorgestrel IUD)

Intervention Type DEVICE

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

Copper IUD or Tubal Ligation

Paragard (Copper IUD ) or Tubal Ligation

Intervention Type DEVICE

Copper IUD placed to provide contraception for up to 10 years

Interventions

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Mirena (Levonorgestrel IUD)

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

Intervention Type DEVICE

Paragard (Copper IUD ) or Tubal Ligation

Copper IUD placed to provide contraception for up to 10 years

Intervention Type DEVICE

Other Intervention Names

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Mirena IUD Paragard IUD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Kiley

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica W Kiley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern Universeity

Locations

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Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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SFP3-3

Identifier Type: -

Identifier Source: secondary_id

STU00014472

Identifier Type: -

Identifier Source: org_study_id