NCT01022645

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

4.8 years

First QC Date

November 25, 2009

Last Update Submit

November 19, 2014

Conditions

Gestational DiabetesGlucose IntoleranceType 2 DiabetesIntrauterine Contraception

Keywords

Intrauterine deviceGestational diabetesPostpartum contraceptionPostpartum birth control

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance at 12 months postpartum.

    12 months

Study Arms (2)

Levonorgestrel IUD

Device: Mirena (Levonorgestrel IUD)

Copper IUD or Tubal Ligation

Device: Paragard (Copper IUD ) or Tubal Ligation

Interventions

Mirena (Levonorgestrel IUD)DEVICE

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

Also known as: Mirena IUD
Levonorgestrel IUD
Paragard (Copper IUD ) or Tubal LigationDEVICE

Copper IUD placed to provide contraception for up to 10 years

Also known as: Paragard IUD
Copper IUD or Tubal Ligation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Postpartum women with gestational diabetes in the last pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diabetes, GestationalGlucose IntoleranceDiabetes Mellitus, Type 2

Interventions

Sterilization, Tubal

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeSterilization, Reproductive

Study Officials

  • Jessica W Kiley, MD, MPH

    Northwestern Universeity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

November 25, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

US(1)