To compare two different insulin regimes for better pregnancy outcome

Comparison of efficacy of PREMIXED SPLIT INSULIN REGIME with MULTIPLE SPLIT INSULIN REGIME on diabetes complicating pregnancy – A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064907

Enrollment

Registered

2024-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: O244- Gestational diabetes mellitus Health Condition 2: O241- Pre-existing type 2 diabetes mellitus, in pregnancy, childbirth and the puerperium Health Condition 3: O243- Unspecified pre-existing diabetesmellitus in pregnancy, childbirth and the puerperium

Interventions

Intervention1: Premixed Split Insulin Regimen (MIXTARD INSULIN – 30% RAPID ACTING INSULIN AND 70% ISOPHANE INSULIN): Premixed Split Insulin Regimen (MIXTARD INSULIN – 30% RAPID ACTING INSULIN AND 70%

Eligibility

Inclusion criteria

Inclusion criteria: All pregnant women with viable, singleton pregnancy with diabetes complicating pregnancy at = 36 weeks in need of insulin therapy, regardless of oral hypoglycemic agents usage

Exclusion criteria

Exclusion criteria: Patients who are known allergic to insulin

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of different insulin regimes in achieving tight glycemic control in diabetes-complicating pregnancyTimepoint: Hypoglycemic episodes Glycemic control at 28 – 30 weeks Glycemic control at 34 – 36 weeks Number of days required to achieve sugar control	—

Secondary

Measure	Time frame
To compare the efficacy of different regimes on maternal & neonatal outcomesTimepoint: UTI infection rates checked during every Antenatal visits, Polyhydramnios diagnosed by USG done at 24 to 28 weeks, 34 to 36 weeks, Prolonged labor observed at 1st & 2nd stage of labor, Shoulder dystocia during delivery, PPH during delivery & till 6 weeks of postpartum, whether is there any IUD or Stillbirth, APGAR score at 1 minute & 5 minutes after the birth of the child, Neonatal hypoglycemia will be checked after birth of baby at 2, 6, 12, 24, 48 hours if baby is found hypoglycemic	—

Measure

Time frame

To compare the efficacy of different regimes on maternal & neonatal outcomesTimepoint: UTI infection rates checked during every Antenatal visits, Polyhydramnios diagnosed by USG done at 24 to 28 weeks, 34 to 36 weeks, Prolonged labor observed at 1st & 2nd stage of labor, Shoulder dystocia during delivery, PPH during delivery & till 6 weeks of postpartum, whether is there any IUD or Stillbirth, APGAR score at 1 minute & 5 minutes after the birth of the child, Neonatal hypoglycemia will be checked after birth of baby at 2, 6, 12, 24, 48 hours if baby is found hypoglycemic

—

Countries

India

Contacts

Public ContactDr Keerthana

Sri manakula vinayagar medical college and hospital

poomalarpragash@gmail.com9442044679

Outcome results

None listed

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