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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Society of Family Planning

Information provided by (Responsible Party):

Jessica Kiley, Northwestern University

ClinicalTrials.gov Identifier:

NCT01022645

First received: November 25, 2009

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2009

Last Updated Date

May 2, 2013

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glucose tolerance at 12 months postpartum. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Glucose tolerance at 12 months postpartum. [ Time Frame: 12 months ]

Change History

Complete list of historical versions of study NCT01022645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Postpartum women with gestational diabetes in the last pregnancy

Condition ^ICMJE

Gestational Diabetes
Glucose Intolerance
Type 2 Diabetes
Intrauterine Contraception

Intervention ^ICMJE

Device: Mirena (Levonorgestrel IUD)
Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use

Other Name: Mirena IUD
Device: Paragard (Copper IUD ) or Tubal Ligation
Copper IUD placed to provide contraception for up to 10 years

Other Name: Paragard IUD

Study Group/Cohort (s)

Levonorgestrel IUD
Intervention: Device: Mirena (Levonorgestrel IUD)
Copper IUD or Tubal Ligation
Intervention: Device: Paragard (Copper IUD ) or Tubal Ligation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01022645

Other Study ID Numbers ^ICMJE

STU00014472, SFP3-3

Has Data Monitoring Committee

Responsible Party

Jessica Kiley, Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

Society of Family Planning

Investigators ^ICMJE

Principal Investigator:

Jessica W Kiley, MD, MPH

Northwestern Universeity

Information Provided By

Northwestern University

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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