Health Condition 1: null- Women with Prediabetes and Diabetes prior to conception through Assisted Reproduction Technology
Conditions
Interventions
Intervention1: Insulin Aspart before major meals &
NPH at bedtime if required: Multiple doses of insulin with dose titrations at regular intervals to maintain near-normoglycemia till delivery
Control Intervention1: Nil: Controls will be normoglycemic
will receive routine antenatal care
Sponsors
DrSNallaperumal
Eligibility
Inclusion criteria
Inclusion criteria: Age up to 45 years, failure to conceive after at least 1 year of unprotected sex, Use of self or donor egg for fertilization, Both IVF naive and repeaters [up to 4 attempts], OGTT normal for normoglycemic arm, OGTT [FBS 101 to 125 mg/dl, 2 hour PPBS 141 to 199 mg/dl] for prediabetic arm, OGTT [FBS > 126 mg/dl, 2 hour PPBS > 200 mg/dl] for diabetics
Exclusion criteria
Exclusion criteria: Male factor infertility [Azoospermia], Impaired fertility caused by endocrine dysfunction other than diabetes mellitus, Smokers, Alcohol and other illicit drug abusers, other medical conditions which contraindicate treatment with Assisted Reproduction Technology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse pregnancy outcomes (congenital abnormalities, Neonatal Hypoglycemia, LGA, SGA, Spontaneous abortions, Stillbirth, neonatal death) in diabetic and prediabetic womenTimepoint: Neonatal Hypoglycemia - From birth to 48 hours. All other outcomes at the time of delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Conception rateTimepoint: 10 weeks from the date of embryo transfer [excludes biochemical pregnancy] | — |
Countries
India
Contacts
Public ContactDr.S.Nallaperumal
Outcome results
None listed