Cardiac changes in the fetuses of pregnant mothers with diabetes receiving insulin and metform

Comparison of cardiac changes in the fetuses of pregnant mothers with diabetes receiving insulin and metformin

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140525017827N14

Enrollment

Registered

2024-12-13

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Gestational Diabetes. Gestational diabetes mellitus in pregnancy

Interventions

Intervention 1: Intervention group: For the intervention group, in addition to insulin, metformin 500 mg will be prescribed 2 to 4 times a day until delivery, depending on the mother's needs and BMI (

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women 18-45years old singleton pregnancy Pregnant women with a previous diagnosis of diabetes who are receiving insulin or fasting blood sugar more than or equal to 126 or a random blood sugar more than 200 or an HbA1C more than 6.5 at the primary care of pregnancy 6 to 13 weeks

Exclusion criteria

Exclusion criteria: Sensitivity or allergy to insulin or metformin Fetus with an anomaly confirmed by ultrasound

Design outcomes

Primary

Measure	Time frame
Mitral and tricuspid valve EA ratio, right and left ventricular hypertrophy. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;Echocardiographic index. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;Echocardiographic findings. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;Birth weight. Timepoint: after birth. Method of measurement: Scale.;Interventricular septal thickness, right and left ventricular wall thickness, shortening fraction. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;LVMPI, RVMPI. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.	—

Measure

Time frame

Mitral and tricuspid valve EA ratio, right and left ventricular hypertrophy. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;Echocardiographic index. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;Echocardiographic findings. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;Birth weight. Timepoint: after birth. Method of measurement: Scale.;Interventricular septal thickness, right and left ventricular wall thickness, shortening fraction. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.;LVMPI, RVMPI. Timepoint: Weeks 18 to 28 of pregnancy, 4 to 8 weeks after starting treatment and after birth. Method of measurement: Echocardiography.

—

Secondary

Measure	Time frame
Neonatal complications including NICU admission; ARDS; neonatal mortality; hyperbilirubinemia. Timepoint: After birth. Method of measurement: Clinical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Asadi

Shiraz University of Medical Sciences

asadin@sums.ac.ir+98 71 3647 9830

Outcome results

None listed

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