Gestational Diabetes MellitusNCT00933881
Gestational Diabetes and Sleep-Disordered Breathing
An observational study of Gestational Diabetes Mellitus, run by Christiana Care Health Services at 1 site in United States.
Trial summary
This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Determining a change in heart rate variability post delivery of the baby
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with Gestational Diabetes Mellitus (GDM)
Who may be able to join
- Pregnant women aged 18-40 years old.
- Pregnant women at gestational age 30 to 34 weeks.
Who cannot join
- Pregnant women with known type 1 or type 2 diabetes mellitus.
- Pregnant women carrying more than one fetus.
- Pregnant women with pre-gestational hypertension.
- Pregnant women with pre-eclampsia during current pregnancy.
- Pregnant women with a history of coronary artery disease or acute ischemia.
- Pregnant women who currently smoke.
Show all 10Show fewer
- Pregnant women without results for the 3 hour 100 gram oral glucose tolerance test.
- Pregnant women with preterm labor, cervical shortening, premature rupture of membranes or any other obstetric complications that may predispose to preterm labor.
- Pregnant women using 17-P (progesterone) to prevent recurrent pre-term labor.
- Pregnant women with known SDB.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services
Newark, Delaware, 19713
About this study
Official title: A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing
This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Determining a change in heart rate variability post delivery of the baby
- Keywords
- GDM
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining a change in heart rate variability post delivery of the babyOther
Determining a change in heart rate variability post delivery of the baby
| Study group | Role | What they receive |
|---|---|---|
| Gestational Diabetes Mellitus (GDM) | Not described Receives: Other: Determining a change in heart rate variability post delivery of the baby |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in heart rate control post-GDM
Measured: Two months after delivery
Secondary outcomes (1)
Improvement in SDB post-GDM
Measured: Two months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933881
- Sponsor's protocol ID
- 28143
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2009
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing
- ClinicalTrials.gov ID
- NCT00933881
- Acronym / sponsor ID
- 28143
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- GDM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Jul 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.
This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gestational Diabetes Mellitus (GDM) | – | Other: Determining a change in heart rate variability post delivery of the baby |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with Gestational Diabetes Mellitus (GDM)
Key inclusion criteria (2 listed)
- Pregnant women aged 18-40 years old.
- Pregnant women at gestational age 30 to 34 weeks.
Key exclusion criteria (10 listed)
- Pregnant women with known type 1 or type 2 diabetes mellitus.
- Pregnant women carrying more than one fetus.
- Pregnant women with pre-gestational hypertension.
- Pregnant women with pre-eclampsia during current pregnancy.
- Pregnant women with a history of coronary artery disease or acute ischemia.
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 |
|---|---|---|
| Determining a change in heart rate variability post delivery of the babyDetermining a change in heart rate variability post delivery of the baby | Other | Gestational Diabetes Mellitus (GDM) |
Primary outcome
Improvement in heart rate control post-GDM
Time frame: Two months after delivery
1 secondary outcome
Improvement in SDB post-GDM
Time frame: Two months after delivery
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 14 Jul 2016.
Related trials for Gestational Diabetes Mellitus
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mellitus, run by Christiana Care Health Services 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 2 inclusion and 10 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 14 Jul 2016. 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?
Improvement in heart rate control post-GDM (time frame: Two months after delivery). 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 14 Jul 2016.