Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway

Objective To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a heal...

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Main Authors: Milada Cvancarova Småstuen, Mirjam Lukasse, Iren Borgen, Anne Flem Jacobsen, Lisa Maria Garnweidner-Holme, Seraj Fayyad, Josef Noll
Format: Article
Language:English
Published: BMJ Publishing Group 2019-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/11/e030884.full
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author Milada Cvancarova Småstuen
Mirjam Lukasse
Iren Borgen
Anne Flem Jacobsen
Lisa Maria Garnweidner-Holme
Seraj Fayyad
Josef Noll
author_facet Milada Cvancarova Småstuen
Mirjam Lukasse
Iren Borgen
Anne Flem Jacobsen
Lisa Maria Garnweidner-Holme
Seraj Fayyad
Josef Noll
author_sort Milada Cvancarova Småstuen
collection DOAJ
description Objective To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet.Design A multicentre, non-blinded randomised controlled trial.Setting Five diabetes outpatient clinics in the Oslo region.Participants Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum.Intervention The Pregnant+ app and usual care, the control group received usual care.Primary and secondary outcomes The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported.Results No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered.Conclusion The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant.Trial registration number NCT02588729.
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spelling doaj-art-33e02788eb90448c9ec50de0d11e5afe2025-08-20T01:54:23ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-030884Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in NorwayMilada Cvancarova Småstuen0Mirjam Lukasse1Iren Borgen2Anne Flem Jacobsen3Lisa Maria Garnweidner-Holme4Seraj Fayyad5Josef Noll6Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway1 Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway1 Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway2 Department of Obstetrics and Gynaecology, Oslo University Hospital Ulleval, Oslo, Norway1 Institute of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway5 Department of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway5 Department of Mathematics and Natural Sciences, University of Oslo, Oslo, NorwayObjective To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet.Design A multicentre, non-blinded randomised controlled trial.Setting Five diabetes outpatient clinics in the Oslo region.Participants Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum.Intervention The Pregnant+ app and usual care, the control group received usual care.Primary and secondary outcomes The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported.Results No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered.Conclusion The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant.Trial registration number NCT02588729.https://bmjopen.bmj.com/content/9/11/e030884.full
spellingShingle Milada Cvancarova Småstuen
Mirjam Lukasse
Iren Borgen
Anne Flem Jacobsen
Lisa Maria Garnweidner-Holme
Seraj Fayyad
Josef Noll
Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway
BMJ Open
title Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway
title_full Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway
title_fullStr Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway
title_full_unstemmed Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway
title_short Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway
title_sort effect of the pregnant smartphone application in women with gestational diabetes mellitus a randomised controlled trial in norway
url https://bmjopen.bmj.com/content/9/11/e030884.full
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