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Insulin treatment method after corticosteroid treatment in preterm labor

A clinical trial: Comparison of two insulin increasement methods in control of blood glucose in pregnant women with diagnosed diabetes on insulin therapy after betamethasone administration due to threatened preterm labor entering Mahdie hospital between 2021-2022: sliding method with increasing patient’s baseline insulin method

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220215054031N1
Enrollment
34
Registered
2022-04-14
Start date
2022-04-14
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Condition 1: Gestational diabetes mellitus on insulin therapy. Condition 2: Overt diabetes mellitus in pregnancy. Condition 3: Pre term labor. Gestational diabetes mellitus in pregnancy, insulin controlled Diabetes mellitus due to underlying condition Preterm labor

Interventions

Intervention 1: Intervention group: In this group we add up 20% of their basal long or intermediate acting insulin at first night after betamethasone injection, for the second and third day we add 30%
is blood sugar is between 100-120, 1 unit is added to the short acting insulin and if blood sugar is over 120, 2 units is added per 10 mg/dl. And if blood sugar is over 140, 1 unit per 10mg/dl is adde

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Gestational age between 24 to 34 weeks Gestational diabetes on insulin therapy Diabetes type 1 or 2 on insulin therapy Completely controlled blood sugar before entrance to trial Corticosteroid therapy before labor Multiple pregnancy

Exclusion criteria

Exclusion criteria: Patients unwilling to enter or continue the study Patient refusing admission in our hospital

Design outcomes

Primary

MeasureTime frame
Blood sugar of patient. Timepoint: For 5 days after betamethasone injection. Method of measurement: Glucometer with milligrams per deciliter scale.;Hypoglycemic events. Timepoint: During 5 days after betamethasone injection. Method of measurement: Blood sugar lower than 60 mg/dl.;Diabetic ketoacidosis: is the combination of high blood sugar and low insulin levels that cause increased ketone body products. Timepoint: During 5 days after betamethasone injection. Method of measurement: Blood sugar with glucometer, Arterial blood gasses assays acidosis and urinary ketone assays with dipstick test.

Secondary

MeasureTime frame
Insulin units increased during 5 days. Timepoint: 5 days after betamethasone injection. Method of measurement: International unit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Samadi Nasab

Shahid Beheshti University of Medical Sciences

faf.samadinasab@gmail.com+98 21 23871

Outcome results

None listed

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