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IRCT20261021071512N1 IRCT 2026-10-26 Lady Reading Hospital A Comparison of Newborn Health Outcomes in Babies Born to Mothers with Gestational Diabetes Treated with Metformin or Insulin NEONATAL OUTCOMES FOLLOWING METFORMIN FIRST VERSUS INSULIN TREATMENT OF MATERNAL GESTATIONAL DIABETES Mellitus, A RCT 2026-11-01 anticipated 560 Recruiting https://irct.ir/trial/94246 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Eligible pregnant women diagnosed with gestational diabetes mellitus will be randomly allocated in a 1:1 ratio to either the metformin-first treatment group or the insulin treatment group. A computer-generated random sequence will be used to determine group allocation. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes prepared by an independent person. Randomization will be performed at the individual participant level. No stratification or block randomization will be used. 3 Gestational Diabetes Mellitus. Intervention group:. Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD) including baseline maternal demographics, gestational diabetes clinical metrics, metformin/insulin intervention logs, and primary/secondary neonatal outcomes (e.g., birth weight, neonatal hypoglycemia incidence, NICU admission rates, APGAR scores, gestational age at birth). The study protocol, statistical analysis plan, and informed consent forms will also be included. When: Data will become available starting 6 months following the official publication of the main study findings in a peer-reviewed journal and will remain accessible for a period of 5 years. To whom: Data will be made available to qualified researchers and clinicians affiliated with academic institutions, university medical centers, or recognized healthcare research organizations who wish to perform secondary data analyses or systematic reviews/meta-analyses. Conditions: Requests will be evaluated for methodologically sound research proposals aimed at improving clinical knowledge on maternal-fetal/neonatal outcomes in gestational diabetes. Requesters must submit a formal research proposal and provide approval from their institution's ethics review board (IRB/ERB). Data must be used strictly for the approved research purpose. Where to obtain: Data can be requested directly from the Principal Investigator or the Department of Obstetrics & Gynecology / Pediatrics at Lady Reading Hospital (LRH), Peshawar, Pakistan. Contact Email:drhinaniaz11@yahoo.com How to obtain: Interested researchers must submit a formal request via email containing: ​A summary of the scientific rationale and research protocol. ​Proof of Institutional Review Board (IRB) / Institutional Ethical Review Board (IERB) approval from Lady Reading Hospital or the applicant's institution. ​A signed Data Use Agreement (DUA) ensuring participant privacy and non-redistribution. ​The request will be reviewed by the research/steering committee within 4 to 6 weeks. Upon approval, anonymized data files will be shared securely via encrypted digital transfer. Comments:
public HINA NIAZ
House no 1967 Gulshan Umar colony Gulberg No 2
Peshawar Pakistan 25000 +92 332 9265356 drhinaniaz11@yahoo.com Lady Reading Hospital scientific HINA NIAZ
House no 1967 Gulshan Umar colony Gulberg No 2
Peshawar Pakistan 25000 +92 332 9265356 drhinaniaz11@yahoo.com Lady Reading Hospital Pakistan Age more than or equal to 18 Single viable pregnancy, randomization at 24 to 33 +6 weeks GDM first diagnosed in the current pregnancy Glucose remaining above the study targets after 7 to 14 days of individualised nutrition/ activity advice and monitoring The women must provide written informed consent Willing to receive either strategy and give permission for infant assessments and follow up 18 years 45 years Female Known pre Gestational type 1 or type 2 Diabetes Overt Diabetes in pregnancy or valid HbA1c more than or equal to 6.5% Urgent need for insulin Ketosis Marked symptomatic hyperglycemia Fasting glucose 6.0 to 6.9 mmol/L accompanied by significant fetal over growth/ polyhydramnios Ongoing glucose lowering medication fir this pregnancy Multiple pregnancy Known major fetal structural or chromosomal anomalies Diagnosed fetal growth restriction Established hypertension or preeclampsia Imminent planned delivery or a condition likely to acquire delivery within 7 days Active significant liver disease Known renal disease or acute kidney injury Acidosis, hypoxia severe infection dehydration or relevant drug allergy Inability to give consent Unresolvable followup O24.41 Gestational diabetes mellitus in pregnancy Treatment - Drugs Intervention group: Neonatal hypoglycemia birthsize prematurity respiratory morbidity NICU mortality maternal weight change insulin rescue delivery mode preeclampsia. Timepoint: 24 to 33 weeks. Method of measurement: Laboratory. Weight, large-for-gestational-age, macrosomia, respiratory distress, NICU admission, preterm birth, low birth weight, Apgar scores (1 and 5 minutes), and neonatal death. Timepoint: 24 weeks antenatal to 28 days post natal. Method of measurement: Laboratory physical assessment stethoscope weight machine. Lady Reading Hospital Approved 2026-09-22 Lady Reading Hospital Medical Teaching Institute Institutional Review Board House 1967 Gulshan Umar colony Gulberg No 2 Peshawar Khyber pukhtoonKhwa Pakistan