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This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.
All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 points blood glucose monitoring | Other | 4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner |
|
| 7 points blood glucose monitoring | Other | 7 points of self monitoring blood glucose which comprises of fasting,1 hour post breakfast, 1 hour pre and post lunch, 1 hour pre and post dinner, pre bed at 10 pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diabetic diet | Dietary Supplement | Patients with gestational diabetes will be seen by the dietitian to be taught diet modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcome of participants | Mean gestational age at delivery in weeks | From date of randomisation up to 40 weeks gestation |
| Pregnancy outcome of participants | Rate of spontaneous or induced labour in percentage | From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour |
| Pregnancy outcome of participants | Rate of vaginal, instrumental or caesarean delivery in percentage | From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn |
| Pregnancy outcome of participants | Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage | From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery |
| Pregnancy outcome of participants | Mean neonatal birth weight in kilogram | At the point of birth of the neonate |
| Pregnancy outcome of participants | Rate of neonates born with Apgar score at five minutes of less than 7 in percentage | At the point of birth of the neonate |
| Pregnancy outcome of participants | Rate of neonatal intensive care unit admission in percentage |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement of treatment in participants | Mean gestational age that the participants are detected to require added treatment in weeks | From the date of randomisation up to 40 weeks gestation |
| Requirement of treatment in participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noor Dalila Berohan | National University of Malaysia | Principal Investigator |
| Norasyikin Abd Wahab | National University of Malaysia | Study Director |
| Shuhaila Ahmad | National University of Malaysia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antenatal clinic, UKM Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia | ||
| National University of Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39110209 | Derived | Berohan ND, Alias H, Ishak S, Mohammed Nawi A, Azman N, Sohaimi D, Kamisan Atan I, Abd Wahab N, Kalok AH, Mohamad AS, Abd Rahman R. 4 vs 7 points self-monitoring blood glucose in gestational diabetes mellitus on diet modification: randomised clinical trial in a single tertiary centre in Malaysia. Arch Gynecol Obstet. 2024 Oct;310(4):1959-1965. doi: 10.1007/s00404-024-07661-5. Epub 2024 Aug 7. |
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The IPD will only be shared upon request. The data that can be shared will be the blood glucose levels and pregnancy outcomes.
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| ID | Term |
|---|---|
| D003927 | Diet, Diabetic |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
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| At the point of birth of the neonate |
| Pregnancy outcome of participants | Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage | From date of randomisation up to 7 days after birth of the neonate |
| Demographic data of participants | Mean age of participants in years | On the date of randomisation |
| Demographic data of participants | Rate of each different races such as Malay, Chinese and Indian in percentage | On the date of randomisation |
| Demographic data of participants | Rate of parity such as nulliparous or multiparous in percentage | On the date of randomisation |
| Demographic data of participants | Mean prepregnancy body mass index in kg/m^2 | On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record |
| Demographic data of participants | Mean total weight gain in kilogram | On the date of randomisation till 40 weeks gestation |
| Demographic data of participants | Rate of positive family history of diabetes mellitus in percentage | On the date of randomisation up to 40 weeks gestation |
| Demographic data of participants | Rate of previous pregnancy affected by gestational diabetes mellitus in percentage | On the date of randomisation up to 40 weeks gestation |
| Demographic data of participants | Rate of previous pregnancy complicated by fetal macrosomia in percentage | On the date of randomisation up to 40 weeks gestation |
| Clinical characteristics of participants | Mean gestational age gestational diabetes mellitus is diagnosed in weeks | On the date of randomisation up to 40 weeks gestation |
| Clinical characteristics of participants | Mean fasting glucose level from the modified glucose tolerance test in mmol/l | On the date of randomisation up to 40 weeks gestation |
| Clinical characteristics of participants | Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l | On the date of randomisation up to 40 weeks gestation |
| Clinical characteristics of participants | Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia, | At the point of randomisation till 40 weeks gestation |
| Clinical characteristics of participants | Mean level of glycosylated haemoglobin in percentage | At the point of randomisation till 40 weeks gestation |
| Clinical characteristics of participants | Mean level of serum fructosamine in percentage | At the point of randomisation till 40 weeks gestation |
| Clinical characteristics of participants | Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l | At the point of randomisation till 40 weeks gestation |
| Clinical characteristics of participants | Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l | At the point of randomisation till 40 weeks gestation |
| Clinical characteristics of participants | Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l | At the point of randomisation till 40 weeks gestation |
Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
| From point of randomisation till 40 weeks gestation |
| Participants' compliance | Rate of frequency of four weekly self blood glucose monitoring in percentage | From point of randomisation till 40 weeks gestation |
| Participants' satisfaction | Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage | From point of randomisation till 40 weeks gestation |
| Cheras |
| Kuala Lumpur |
| 56000 |
| Malaysia |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |