Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN)
Introduction Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-07-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e052554.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832578893467353088 |
|---|---|
| author | Khalida Ismail Boon How Chew Iliatha Papachristou Nadal Angus Forbes Nurul Iftida Basri Rozita Zakaria Pamela Phui Har Yap Veronika Rysinova Intan Nureslyna Samsudin Nurain Mohd Noor Ziti Akthar Supian Haslinda Hassan Fuziah Paimin Siti Rohani Mohamed Alias Norizzati Bukhary Ismail Bukhary Madeleine Benton |
| author_facet | Khalida Ismail Boon How Chew Iliatha Papachristou Nadal Angus Forbes Nurul Iftida Basri Rozita Zakaria Pamela Phui Har Yap Veronika Rysinova Intan Nureslyna Samsudin Nurain Mohd Noor Ziti Akthar Supian Haslinda Hassan Fuziah Paimin Siti Rohani Mohamed Alias Norizzati Bukhary Ismail Bukhary Madeleine Benton |
| author_sort | Khalida Ismail |
| collection | DOAJ |
| description | Introduction Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes.Methods and analysis This retrospective cohort and nested case–control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother–infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported.Ethics and dissemination This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals. |
| format | Article |
| id | doaj-art-6ae395593a1b489b968492e741b550bc |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-6ae395593a1b489b968492e741b550bc2025-01-30T13:35:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-052554Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN)Khalida Ismail0Boon How Chew1Iliatha Papachristou Nadal2Angus Forbes3Nurul Iftida Basri4Rozita Zakaria5Pamela Phui Har Yap6Veronika Rysinova7Intan Nureslyna Samsudin8Nurain Mohd Noor9Ziti Akthar Supian10Haslinda Hassan11Fuziah Paimin12Siti Rohani Mohamed Alias13Norizzati Bukhary Ismail Bukhary14Madeleine Benton15Department of Psychological Medicine, King`s College London Institute of Psychiatry Psychology and Neuroscience, London, UKDepartment of Family Medicine, Faculty of Medicine & Health Sciences, Universiti Putra Malaysia, Serdang, MalaysiaFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UKDivision of Care in Long-term Conditions, King`s College London, London, UKDepartment of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, MalaysiaKlinik Kesihatan Putrajaya Presint 18, Ministry of Health Malaysia, Putrajaya, MalaysiaDepartment of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, MalaysiaDepartment of Psychological Medicine, King`s College London Institute of Psychiatry Psychology and Neuroscience, London, UKDepartment of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, MalaysiaClinical Research Centre (CRC), Hospital Putrajaya Malaysia, Putrajaya, MalaysiaKlinik Kesihatan Seri Kembangan, Ministry of Health Malaysia, Seri Kembangan, Selangor, MalaysiaKlinik Kesihatan Puchong, Ministry of Health Malaysia, Puchong, Selangor, MalaysiaKlinik Kesihatan Putrajaya Presint 9, Ministry of Health Malaysia, Putrajaya, MalaysiaKlinik Kesihatan Kajang, Ministry of Health Malaysia, Kajang, Selangor, MalaysiaKlinik Kesihatan Bangi, Ministry of Health Malaysia, Bangi, Selangor, MalaysiaDepartment of Psychological Medicine, King`s College London Institute of Psychiatry Psychology and Neuroscience, London, UKIntroduction Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes.Methods and analysis This retrospective cohort and nested case–control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother–infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported.Ethics and dissemination This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.https://bmjopen.bmj.com/content/12/7/e052554.full |
| spellingShingle | Khalida Ismail Boon How Chew Iliatha Papachristou Nadal Angus Forbes Nurul Iftida Basri Rozita Zakaria Pamela Phui Har Yap Veronika Rysinova Intan Nureslyna Samsudin Nurain Mohd Noor Ziti Akthar Supian Haslinda Hassan Fuziah Paimin Siti Rohani Mohamed Alias Norizzati Bukhary Ismail Bukhary Madeleine Benton Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) BMJ Open |
| title | Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) |
| title_full | Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) |
| title_fullStr | Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) |
| title_full_unstemmed | Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) |
| title_short | Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN) |
| title_sort | study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes gdm ridman |
| url | https://bmjopen.bmj.com/content/12/7/e052554.full |
| work_keys_str_mv | AT khalidaismail studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT boonhowchew studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT iliathapapachristounadal studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT angusforbes studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT nuruliftidabasri studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT rozitazakaria studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT pamelaphuiharyap studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT veronikarysinova studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT intannureslynasamsudin studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT nurainmohdnoor studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT zitiaktharsupian studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT haslindahassan studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT fuziahpaimin studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT sitirohanimohamedalias studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT norizzatibukharyismailbukhary studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman AT madeleinebenton studyprotocolonriskfactorsforthediagnosisofgestationaldiabetesmellitusindifferenttrimestersandtheirrelationtomaternalandneonataloutcomesgdmridman |