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Clinical Trials/NCT01022645
NCT01022645CompletedNot Applicable

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

Northwestern University1 site in 1 country42 target enrollmentStarted: November 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
Glucose tolerance at 12 months postpartum.

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Glucose tolerance at 12 months postpartum.

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jessica Kiley

Prinicipal Investigator

Northwestern University

Study Sites (1)

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