Gestational DiabetesNCT01022645
Postpartum Glucose Tolerance With Levonorgesterel IUD Use in Women With Recent Gestational Diabetes
An observational study of Gestational Diabetes and Glucose Intolerance, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Glucose Intolerance, Type 2 Diabetes
- What is being tested?
- Mirena (Levonorgestrel IUD) and Paragard (Copper IUD ) or Tubal Ligation
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Postpartum women with gestational diabetes in the last pregnancy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation; Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study
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).
- Being tested
- Mirena (Levonorgestrel IUD), Paragard (Copper IUD ) or Tubal Ligation
- Keywords
- Intrauterine device, Gestational diabetes, Postpartum contraception, Postpartum birth control
- Medical subject headings
- Diabetes, Gestational, Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirena (Levonorgestrel IUD)Device
Also called Mirena IUD
Release of intrauterine levonorgestrel for contraception, approved for up to 5 years' use
Paragard (Copper IUD ) or Tubal LigationDevice
Also called Paragard IUD
Copper IUD placed to provide contraception for up to 10 years
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel IUD | Not described Receives: Device: Mirena (Levonorgestrel IUD) | |
| Copper IUD or Tubal Ligation | Not described Receives: Device: Paragard (Copper IUD ) or Tubal Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance at 12 months postpartum.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Jessica Kiley, Northwestern University
- Investigators
- Jessica W Kiley, MD, MPH, Principal investigator, Northwestern Universeity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022645
- Sponsor's protocol ID
- STU00014472
- Other IDs
- SFP3-3
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2009
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Glucose Tolerance in Women With Recent Gestational Diabetes Using the Levonorgestrel IUD and Non-Hormonal Contraception: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01022645
- Acronym / sponsor ID
- STU00014472
- Keywords
- Intrauterine device, Gestational diabetes, Postpartum contraception, Postpartum birth control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Nov 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel IUD | – | Device: Mirena (Levonorgestrel IUD) |
| Copper IUD or Tubal Ligation | – | Device: Paragard (Copper IUD ) or Tubal Ligation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Postpartum women with gestational diabetes in the last pregnancy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirena (Levonorgestrel IUD)Also: Mirena IUDRelease of intrauterine levonorgestrel for contraception, approved for up to 5 years' use | Device | Levonorgestrel IUD |
| Paragard (Copper IUD ) or Tubal LigationAlso: Paragard IUDCopper IUD placed to provide contraception for up to 10 years | Device | Copper IUD or Tubal Ligation |
Primary outcome
Glucose tolerance at 12 months postpartum.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica W Kiley, MD, MPH principal investigator
Northwestern Universeity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Glucose Intolerance, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance at 12 months postpartum. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.