Diabetes Group Prenatal Care
3 januari 2018 uppdaterad av: Washington University School of Medicine
Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
The investigators primary objective is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities in women with diabetes.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Long term, the investigators aim to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes.
The objective of this proposal is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities, which have been associated with improved glycemic control, in women with diabetes.
Studietyp
Interventionell
Inskrivning (Faktisk)
84
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Colorado
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Denver, Colorado, Förenta staterna, 80204
- Denver Health
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63110
- Washington University in St. Louis
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- English (WUMC) or Spanish speaking (DH)
- Type 2 White's Class B diabetes OR gestational diabetes diagnosed by 2-step method < 32 weeks
- Ability to attend group prenatal visit at specified days and times
- Willingness to be randomized
- Randomization at 22 weeks 0 days-32 weeks 0 days
- Ability to give informed consent
Exclusion Criteria:
- Multiple gestation
- Major fetal anomaly
- Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider
- Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Routine Prenatal Care
Subjects randomized to routine care will receive their care in the usual diabetic clinic attended by residents and faculty.
They will receive consultation with the diabetes educator at diagnosis and as needed.
Patients are seen every 2 weeks (or more by provider discretion) until 37 weeks and weekly until delivery.
Visits are 10-15 minutes and focus on routine screening tests and review of blood sugar logs/medication titration.
Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.
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Experimentell: Group prenatal care
Group visits will be held every 2 weeks in a continuous cycle through a four session curriculum.
Women will have weekly visits beginning at 37 weeks with traditional prenatal visits on the weeks when the group does not meet.
Groups of 4-12 women will meet for two hour visits and much of that time will be spent on pregnancy, behavioral health, diabetes and nutrition education.
Groups will be co-facilitated by 2 CenteringPregnancy trained providers at each site and an obstetric provider.
Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider.
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Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
Tidsram: 37-39 weeks gestation
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Determine the effect of group prenatal care on maternal diabetes self-care activities as measured by the Diabetes Self-care Activities Measure and confirmed by percentage of recommended blood glucose values completed on logs since initial study visit.
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37-39 weeks gestation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale
Tidsram: baseline and 4-12 weeks postpartum
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Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale
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baseline and 4-12 weeks postpartum
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effect of group prenatal care on perceived social support as assessed by the Social Support Scale
Tidsram: 37-39 weeks
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Determine the effect of group prenatal care on perceived social support through the Social Support Scale
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37-39 weeks
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Birthweight
Tidsram: delivery admission
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Determine the effect of group prenatal care on birthweight
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delivery admission
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Gestational age at delivery
Tidsram: delivery admission
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Determine the effect of group prenatal care on preterm delivery
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delivery admission
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Mean 3rd trimester fasting blood glucose
Tidsram: baseline through delivery
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Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose
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baseline through delivery
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Breastfeeding
Tidsram: 4-12 weeks postpartum
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Determine the effect of group prenatal care on initiating breastfeeding
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4-12 weeks postpartum
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Contraception
Tidsram: 4-12 weeks postpartum
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Determine the effect of group prenatal care on initiating contraception
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4-12 weeks postpartum
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studierektor: Methodius G Tuuli, MD, MPH, Assistant Professor, Washington University in St. Louis
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2015
Primärt slutförande (Faktisk)
6 juli 2017
Avslutad studie (Faktisk)
27 september 2017
Studieregistreringsdatum
Först inskickad
27 april 2015
Först inskickad som uppfyllde QC-kriterierna
13 maj 2015
Första postat (Uppskatta)
14 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201503174
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