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Comparison of the effect of antenatal dexamethasone and betamethasone on blood sugar control in diet-controlled gestational diabetics

A randomized controlled trial of antenatal dexamethasone versus betamethasone on glycemic control in diet-controlled gestational diabetics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11357822
Enrollment
150
Registered
2021-01-21
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus arising in pregnancy

Interventions

Eligible women who are about to receive antenatal corticosteroids will be approached to participate. Participants will be randomized to either 4 x 6 mg 12-hourly doses of intramuscular dexamethasone o

Sponsors

University of Malaya Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Gestational diabetes adequately controlled by lifestyle modification (gestational diabetes mellitus was defined as 75 g oral glucose tolerance test (OGTT) fasting blood glucose =5.1 mmol/l and/or 2 hours post-prandial glucose =7.8 mmol/l in pregnant women without prior history of hyperglycemia based on Malaysian National Clinical Practice Guideline diagnostic thresholds 2. Gestational age 24-37 weeks 3. Age =18 years old 4. Singleton pregnancy

Exclusion criteria

Exclusion criteria: 1. Patients on anti-glycemic agent 2. Baseline (at recruitment) capillary blood glucose level =11 mmol/l 3. Active labor or having a high likelihood to deliver within the next 24 hours 4. Suspected chorioamnionitis, suspected maternal or fetal infection 5. On beta-sympathomimetic agent tocolysis 6. On oral intake restriction in anticipation of imminent (within next 24 hours) Cesarean birth

Design outcomes

Primary

MeasureTime frame
1. Hyperglycemia episodes in the first 24 hours following administration of antenatal corticosteroids, measured by point of care capillary blood glucose monitoring system at six points (pre and post breakfast, lunch and dinner) . Hyperglycemia is defined as pre-meal blood glucose level of more than 5.3 mmol/l and 2 hours postprandial/meal blood glucose of more than 6.7 mmol/l 2. Hyperglycemia episodes in the second 24 hours following administration of antenatal corticosteroids, by measuring point of care capillary blood glucose at points 7-12

Secondary

MeasureTime frame
1. Need for an anti-glycaemic agent (metformin or insulin), as indicated by capillary blood glucose levels for the duration of monitoring 2. Maternal outcomes assessed by reviewing patient’s notes after delivery: 2.1. Mode of delivery 2.2. Estimated blood loss during delivery 3. Neonatal outcome assessed by reviewing patient’s and newborn’s notes after delivery: 3.1. Birth weight 3.2. Umbilical cord arterial pH at birth 3.3. Apgar score at first and fifth minute of life 3.4. Neonatal admission to special care nursery or neonatal intensive care 4. Patient satisfaction with their allocated antenatal dexamethasone or betamethasone regime measured using numerical rating score (NRS) score after 3 days of monitoring or as soon as possible after delivery if it occurs sooner

Countries

Malaysia

Contacts

Public ContactFathimath Shamaa Shareef
mgg190023@siswa.um.edu.my+60 (0)139208395

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026