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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin group | Experimental |
| |
| No treatment group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 1700 mg around 22:00. Modifications may take place according to glycemic control |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maternal daily glucose values | According to daily glucose charts | Up to 4 days |
| The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks) | Up to 7 days after delivery or discharge (which ever comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maternal daily pre-prandial glucose values | According to daily glucose charts | Up to 4 days |
| Mean maternal daily post-prandial glucose values | According to daily glucose charts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baruch Padeh Medical center, Poriya | Tiberias | North | 15208 | Israel | ||
| Emek medical center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41511771 | Derived | Yefet E, Massalha M, Talmon G, Labay A, Matanis M, Sleman E, Nassra R, Frank Wolf M, Sgayer I, Lowenstein L, Nachum Z. Metformin, Maternal Glycemic Control, and Neonatal Hypoglycemia After Antenatal Steroids: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2552807. doi: 10.1001/jamanetworkopen.2025.52807. |
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IPD will be shared according to the local review board regulations
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Up to 4 days |
| Percent of abnormal values in the daily glucose chart | According to daily glucose charts | Up to 4 days |
| Rate of cesarean sections and operative deliveries | At delivery |
| Rate of neonates who will be admitted to the neonatal intensive care unit | APGAR scale of 0-worst and 10-best | Up to a week after delivery |
| Apgar score at 1 and 5 minutes | At delivery |
| Cord blood pH levels (when taken) | At delivery |
| The rate of neonates with hyperbilirubinemia | Up to 7 days after delivery or discharge (which ever comes first) |
| Neonatal mean head circumference | Up to 7 days after delivery or discharge (which ever comes first) |
| Neonatal mean birth weight | at delivery |
| The rate of fetal malformations and developmental disorders | Up to 7 days after delivery or discharge (which ever comes first) |
| Mean and lowest neonatal blood glucose values in preterm neonates | Up to 7 days after delivery or discharge (which ever comes first) |
| The rate of maternal adverse effects | 48 hours |
| Afula |
| Israel |
| Galilee medical center | Nahariya | Israel |
| Ziv medical center | Safed | Israel |