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NCT04332393
Metformin to Treat Corticosteroids-induced Hyperglycemia
Phase 4 trial testing Metformin in Pregnancy Preterm in 187 participants. Completed in 5 May 2025.
7 July 2024
Quick facts
| Lead sponsor | The Baruch Padeh Medical Center, Poriya |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 187 |
| Start date | 5 July 2020 |
| Primary completion | 7 July 2024 |
| Estimated completion | 5 May 2025 |
| Sites | 4 locations across Israel |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
Conditions studied
- Pregnancy Preterm — all drugs for Pregnancy Preterm →
- Glycemic Control — all drugs for Glycemic Control →
- Corticosteroids Induced Hyperglycemia — all drugs for Corticosteroids Induced Hyperglycemia →
Sponsor
The Baruch Padeh Medical Center, Poriya
Who can join
18 and older, female only, with Pregnancy Preterm or Glycemic Control. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes. Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates. In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Metformin, Maternal Glycemic Control, and Neonatal Hypoglycemia After Antenatal Steroids: A Randomized Clinical Trial.
Yefet E, Massalha M, Talmon G, Labay A, et al · · 2026 · PMID 41511771 · DOI 10.1001/jamanetworkopen.2025.52807
Verify or expand the search:
- PubMed search for NCT04332393
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metformin
Trials testing the same drug.
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- NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
- NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
- NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting
Other recruiting trials for Pregnancy Preterm
Currently open trials in the same condition.
- NCT06963528 — Gestational Diabetes Monitoring and Management · active not recruiting
- NCT04433364 — COPE - COVID-19 in Pregnancy and Early Childhood · active not recruiting
- NCT05651347 — Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction · Phase 3 · recruiting
Other The Baruch Padeh Medical Center, Poriya trials
Trials by the same sponsor.
- NCT06604559 — The Effect of Patient Discharge From the Maternal and Fetal Medicine Unit With Receiving a Discharge Letter Later Using · NA · recruiting
- NCT04464005 — Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing · Phase 4 · unknown
- NCT05242211 — Cardio-Pulmonary Exercise Testing in Healthy Population · NA · unknown
- NCT05263687 — Exercise Testing in Diseases and Health · NA · unknown
- NCT03167567 — The Effect of Medical Clowning During Labor · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04332393 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Baruch Padeh Medical Center, Poriya
- Last refreshed: 9 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04332393.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing