Metformin to Treat Corticosteroids-induced Hyperglycemia

• Sponsor: The Baruch Padeh Medical Center, Poriya (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04332393
• Collaborator: (none)
• Enrollment: 323
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.6
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Preterm; Glycemic Control; Corticosteroids Induced Hyperglycemia	Drug: Metformin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Metformin in Pregnant Women Who Received Antenatal Corticosteroids on Glycemic Control and the Rate of Neonatal Hypoglycemia - Multicenter Prospective Randomized, Controlled Trial
• Actual Study Start Date: May 15, 2020
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metformin group	Drug: Metformin; Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 850 mg around 22:00. Modifications may take place according to glycemic control
No Intervention: No treatment group

Outcome Measures

Primary Outcome Measures

1. Mean maternal daily glucose values [Up to 4 days]

   According to daily glucose charts

2. The rate of neonatal hypoglycemia in preterm deliveries (<37 gestational weeks) [Up to 7 days after delivery or discharge (which ever comes first)]

Secondary Outcome Measures

1. Mean maternal daily pre-prandial glucose values [Up to 4 days]

   According to daily glucose charts

2. Mean maternal daily post-prandial glucose values [Up to 4 days]

   According to daily glucose charts

3. Percent of abnormal values in the daily glucose chart [Up to 4 days]

   According to daily glucose charts

4. Rate of cesarean sections and operative deliveries [At delivery]

5. Rate of neonates who will be admitted to the neonatal intensive care unit [Up to a week after delivery]

   APGAR scale of 0-worst and 10-best

6. Apgar score at 1 and 5 minutes [At delivery]

7. Cord blood pH levels (when taken) [At delivery]

8. The rate of neonates with hyperbilirubinemia [Up to 7 days after delivery or discharge (which ever comes first)]

9. Neonatal mean head circumference [Up to 7 days after delivery or discharge (which ever comes first)]

10. Neonatal mean birth weight [at delivery]

11. The rate of fetal malformations and developmental disorders [Up to 7 days after delivery or discharge (which ever comes first)]

12. Mean and lowest neonatal blood glucose values in preterm neonates [Up to 7 days after delivery or discharge (which ever comes first)]

13. The rate of maternal adverse effects [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women receiving betamethasone from 24 to 36.5 gestational weeks

• Before or within 24 hours following the first dose of betamethasone

• ≥18 years old

Exclusion Criteria:

• Women with pre-gestational and gestational diabetes mellitus (GDM)

• Known allergic sensitivity to metformin

• Known chronic heart failure

• Known chronic renal failure

• Refuse to participate

• Refuse to perform glucose challenge test/glucose tolerance test later on

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baruch Padeh Medical center, Poriya	Tiberias	North	Israel	15208

Sponsors and Collaborators

• The Baruch Padeh Medical Center, Poriya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Baruch Padeh Medical Center, Poriya
• ClinicalTrials.gov Identifier: NCT04332393
• Other Study ID Numbers: 21-20POR
• First Posted: Apr 2, 2020
• Last Update Posted: May 19, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperglycemia; Metformin

Study Results

No Results Posted as of May 19, 2020