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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Antenatal clinic, UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
National University of Malaysia
Cheras, Kuala Lumpur, Malaysia
Pregnancy outcome of participants
Mean gestational age at delivery in weeks
Time frame: From date of randomisation up to 40 weeks gestation
Pregnancy outcome of participants
Rate of spontaneous or induced labour in percentage
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the point of birth of the neonate
Pregnancy outcome of participants
Rate of neonatal intensive care unit admission in percentage
Time frame: At the point of birth of the neonate
Pregnancy outcome of participants
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Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage
Time frame: From date of randomisation up to 7 days after birth of the neonate
Demographic data of participants
Mean age of participants in years
Time frame: On the date of randomisation
Demographic data of participants
Rate of each different races such as Malay, Chinese and Indian in percentage
Time frame: On the date of randomisation
Demographic data of participants
Rate of parity such as nulliparous or multiparous in percentage
Time frame: On the date of randomisation
Demographic data of participants
Mean prepregnancy body mass index in kg/m\^2
Time frame: 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
Time frame: On the date of randomisation till 40 weeks gestation
Demographic data of participants
Rate of positive family history of diabetes mellitus in percentage
Time frame: 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
Time frame: On the date of randomisation up to 40 weeks gestation
Demographic data of participants
Rate of previous pregnancy complicated by fetal macrosomia in percentage
Time frame: On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Mean gestational age gestational diabetes mellitus is diagnosed in weeks
Time frame: 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
Time frame: 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
Time frame: 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,
Time frame: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of glycosylated haemoglobin in percentage
Time frame: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of serum fructosamine in percentage
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the point of randomisation till 40 weeks gestation
Requirement of treatment in participants
Mean gestational age that the participants are detected to require added treatment in weeks
Time frame: From the date of randomisation up to 40 weeks gestation
Requirement of treatment in participants
Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
Time frame: From point of randomisation till 40 weeks gestation
Participants' compliance
Rate of frequency of four weekly self blood glucose monitoring in percentage
Time frame: From point of randomisation till 40 weeks gestation
Participants' satisfaction
Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage
Time frame: From point of randomisation till 40 weeks gestation