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Completed

NCT Number: NCT04101396

4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification

This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antenatal clinic, UKM Medical Centre, Cheras, Kuala Lumpur, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-45 years old
  • Pregnant women with gestational diabetes mellitus on diet modification
  • Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks
  • Gestational age at recruitment 20-34 week

Exclusion criteria

  • bad obstetrics history.
  • Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids
  • fetal anomaly.
  • Women planning to deliver in other centres
  • Women who refuse to participate

Treatment and study plan

Diabetic diet

Dietary Supplement

Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

Primary outcomes

  1. Pregnancy outcome of participants

    Time frame: From date of randomisation up to 40 weeks gestation

    Mean gestational age at delivery in weeks

  2. Pregnancy outcome of participants

    Time frame: From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour

    Rate of spontaneous or induced labour in percentage

  3. Pregnancy outcome of participants

    Time frame: From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn

    Rate of vaginal, instrumental or caesarean delivery in percentage

  4. Pregnancy outcome of participants

    Time frame: From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery

    Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage

  5. Pregnancy outcome of participants

    Time frame: At the point of birth of the neonate

    Mean neonatal birth weight in kilogram

  6. Pregnancy outcome of participants

    Time frame: At the point of birth of the neonate

    Rate of neonates born with Apgar score at five minutes of less than 7 in percentage

  7. Pregnancy outcome of participants

    Time frame: At the point of birth of the neonate

    Rate of neonatal intensive care unit admission in percentage

  8. Pregnancy outcome of participants

    Time frame: From date of randomisation up to 7 days after birth of the neonate

    Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage

  9. Demographic data of participants

    Time frame: On the date of randomisation

    Mean age of participants in years

  10. Demographic data of participants

    Time frame: On the date of randomisation

    Rate of each different races such as Malay, Chinese and Indian in percentage

  11. Demographic data of participants

    Time frame: On the date of randomisation

    Rate of parity such as nulliparous or multiparous in percentage

  12. Demographic data of participants

    Time frame: On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record

    Mean prepregnancy body mass index in kg/m^2

  13. Demographic data of participants

    Time frame: On the date of randomisation till 40 weeks gestation

    Mean total weight gain in kilogram

  14. Demographic data of participants

    Time frame: On the date of randomisation up to 40 weeks gestation

    Rate of positive family history of diabetes mellitus in percentage

  15. Demographic data of participants

    Time frame: On the date of randomisation up to 40 weeks gestation

    Rate of previous pregnancy affected by gestational diabetes mellitus in percentage

  16. Demographic data of participants

    Time frame: On the date of randomisation up to 40 weeks gestation

    Rate of previous pregnancy complicated by fetal macrosomia in percentage

  17. Clinical characteristics of participants

    Time frame: On the date of randomisation up to 40 weeks gestation

    Mean gestational age gestational diabetes mellitus is diagnosed in weeks

  18. Clinical characteristics of participants

    Time frame: On the date of randomisation up to 40 weeks gestation

    Mean fasting glucose level from the modified glucose tolerance test in mmol/l

  19. Clinical characteristics of participants

    Time frame: On the date of randomisation up to 40 weeks gestation

    Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l

  20. Clinical characteristics of participants

    Time frame: At the point of randomisation till 40 weeks gestation

    Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,

  21. Clinical characteristics of participants

    Time frame: At the point of randomisation till 40 weeks gestation

    Mean level of glycosylated haemoglobin in percentage

  22. Clinical characteristics of participants

    Time frame: At the point of randomisation till 40 weeks gestation

    Mean level of serum fructosamine in percentage

  23. Clinical characteristics of participants

    Time frame: At the point of randomisation till 40 weeks gestation

    Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l

  24. Clinical characteristics of participants

    Time frame: At the point of randomisation till 40 weeks gestation

    Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l

  25. Clinical characteristics of participants

    Time frame: At the point of randomisation till 40 weeks gestation

    Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l

Secondary outcomes

  1. Requirement of treatment in participants

    Time frame: From the date of randomisation up to 40 weeks gestation

    Mean gestational age that the participants are detected to require added treatment in weeks

  2. Requirement of treatment in participants

    Time frame: From 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

  3. Participants' compliance

    Time frame: From point of randomisation till 40 weeks gestation

    Rate of frequency of four weekly self blood glucose monitoring in percentage

  4. Participants' satisfaction

    Time frame: From point of randomisation till 40 weeks gestation

    Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2019
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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