An interventional study of Sleep Education for Pregnancy in Gestational Diabetes Mellitus in Pregnancy, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.
Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual care vs. sleep education program).
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 74 is below the median of 110 across 560 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a two-session program designed to educate patients about healthy sleep in respect to timing, regularity, efficiency, and duration in order to promote sleep during pregnancy.
Behavioral: Sleep Education for Pregnancy
Usual care
Sleep education specific to pregnancy
Glycemic control
Proportion of participants achieving glycemic control at study end. Glycemic control defined as greater than 75% of weeks with average fasting blood glucose \< 95 mg/dL and 1-hr postprandial blood glucose \<140 mg/dL.
Time frame: 3-6 months during pregnancy
Self-reported sleep duration
Proportion of patients who report sleeping between 7-9 hours per night
Time frame: 3-6 months during pregnancy
Average fasting glucose values
Time frame: 3-6 months during pregnancy
Average postprandial glucose values
Time frame: 3-6 months during pregnancy
Gestational age at delivery
Time frame: Time of delivery
Neonatal birth weight
Time frame: Time of delivery
Indication for delivery
Medical records will be used to determine whether a patient when into spontaneous labor, had an induction or labor or a recommended delivery by cesarean section. If the patient had an induction or labor or a recommended cesarean delivery, the indication for this recommendation will be recorded.
Time frame: Time of delivery
Route of delivery
Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.
Time frame: Time of delivery
Preeclampsia
Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.
Time frame: Time of delivery
Plan to share: No
Ran from Nov 2017 to primary completion in Jun 2019, 19 months.
Of 303 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's 19 months is below that.
Counting every sponsor, half of 306 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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