NCT00933881

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

7.3 years

First QC Date

July 6, 2009

Last Update Submit

July 13, 2016

Conditions

Gestational Diabetes Mellitus

Keywords

GDM

Outcome Measures

Primary Outcomes (1)

  • Improvement in heart rate control post-GDM

    Two months after delivery

Secondary Outcomes (1)

  • Improvement in SDB post-GDM

    Two months after delivery

Study Arms (1)

Gestational Diabetes Mellitus (GDM)

Other: Determining a change in heart rate variability post delivery of the baby

Interventions

Determining a change in heart rate variability post delivery of the babyOTHER

Determining a change in heart rate variability post delivery of the baby

Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with Gestational Diabetes Mellitus (GDM)

You may qualify if:

  • Pregnant women aged 18-40 years old.
  • Pregnant women at gestational age 30 to 34 weeks.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 7, 2009

Study Start

November 1, 2008

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

US(1)