A clinical trial to assess the frequency of "low sugar" in the mother with elevated sugars (during pregnancy) using insulin aspart.

An open-label, prospective study to observe the incidence of hypoglycemia with insulin aspart in pregnant women with any degree of hyperglycemia. HIP - INDIA study i.e. Hyperglycemia In Pregnancy- India study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000070

Enrollment

200

Registered

2008-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: INSULIN ASPART: DOSE OF INSULIN ACCORDING TO HYPERGLYCEMIA, INSULIN CONTINUED TILL DELIVERY Control Intervention1: nil will be compared with historical controls available in the literat

Eligibility

Inclusion criteria

Inclusion criteria: PREGNANT PATIENTS WITH ANY DEGREE OF HYPERGLYCEMIA (OGTT AFTER 75 GM OF GLUCOSE > 130MG/DL) INITIATED WITH OR WITHOUT OTHER INTERMEDIATE ACTING INSULINS AND/OR METFORMIN.

Exclusion criteria

Exclusion criteria: PREGNANT HYPERGLYCEMIC PATIENTS WITH ORAL ANTIDIABETIC AGENTS (EXCEPT METFORMIN) INITIATED ELSEWHERE PREGNANT HYPERGLYCEMIC PATIENTS WITH PREDIAGNOSED MACROSOMIA

Design outcomes

Primary

Measure	Time frame
TO ASSESS THE FREQUENCY OF HYPOGLYCEMIA WITH INSULIN ASPARTTimepoint: THROUGHOUT PREGNANCY FROM DATE OF INITIATION OF INSULIN ASPART	—

Secondary

Measure	Time frame
TO ASSESS THE FREQUENCY OF MACROSOMIA (> 3.5 KG BODY WEIGHT) IN PREGNANT DIABETIC WOMENW ITH WELL CONTROLLED SUGARS TO LOOK AT THE USG BASED GROWTH CENTILE WITH SPECIFIC REGARDS TO THE ABDOMINAL CIRCUMFERENCE AND TO LOOK AT THE CORELATION BETWEEN GOOD GLYCEMIC CONTROL AND OUTCOMES. TO ASSESS THE FREQUENCY OF FETAL COMPLICATIONS E.G. NEONATAL HYPOGLYCEMIA, DEVELOPMENT OF CONGENITAL ANOMALIES IN WOMEN WITH GOOD CONTROL OF SUGARSTimepoint: THROUGHOUT PREGNANCY FROM DATE OF INITIATION OF INSULIN ASPART	—

Measure

Time frame

TO ASSESS THE FREQUENCY OF MACROSOMIA (> 3.5 KG BODY WEIGHT) IN PREGNANT DIABETIC WOMENW ITH WELL CONTROLLED SUGARS TO LOOK AT THE USG BASED GROWTH CENTILE WITH SPECIFIC REGARDS TO THE ABDOMINAL CIRCUMFERENCE AND TO LOOK AT THE CORELATION BETWEEN GOOD GLYCEMIC CONTROL AND OUTCOMES. TO ASSESS THE FREQUENCY OF FETAL COMPLICATIONS E.G. NEONATAL HYPOGLYCEMIA, DEVELOPMENT OF CONGENITAL ANOMALIES IN WOMEN WITH GOOD CONTROL OF SUGARSTimepoint: THROUGHOUT PREGNANCY FROM DATE OF INITIATION OF INSULIN ASPART

—

Countries

India

Contacts

Public ContactMRS VRINDA DEEPAK

drmcdeepak@yahoo.co.uk044-26189798

Outcome results