Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Study Overview
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Brief Summary
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Use of antenatal corticosteroids therapy has increased since the 2000s. The benefits of such a therapy on premature newborns are scientifically and internationally recognized. Nevertheless, few studies have been conducted to investigate the impact of this antenatal corticosteroid therapy on full-term newborns (> 36 weeks' gestation). The aim of this study is to compare the birth parameters of full-term newborns exposed or not to antenatal corticosteroid therapy.

Detailed Description
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All children included in the study were born at the Regional Maternity Hospital of Nancy between January 1, 2014 and December 31, 2020. One hundred and twenty-one of them were exposed during pregnancy to antenatal corticosteroids therapy and constitute the exposed arm, whereas 242 were not and constitute the non-exposed arm. Data were collected retrospectively regarding history of pregnancy, birth parameters and neonatal adaptation.

Official Title
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Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Conditions
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Growth Retardation

Intervention / Treatment
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* Drug: Betamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea because of a threat of premature delivery only full-term newborns Exclusion Criteria: all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exposed group (121 patients)<br>Extrated from the population of full-term newborns (> 36 weeks of amenorrhea + 6 days) between 2014 and 2020 at the Regional Maternity Hospital of Nancy who received at least one course of betamethasone before 34 weeks of amenorrhea for a threat of preterm delivery. Exposure to an antenatal corticosteroid therapy was defined as the administration of at least one course of betamethasone (i.e. two doses of 12 mg, 24 hours apart). in intramuscular, before 34 weeks of amenorrhea, for a threat of premature delivery. | Drug: Betamethasone<br> <br> |
| nonexposed group (242 patients)<br>came from the population of full-term newborns (> 36 weeks of amenorrhea + 6 days) between 2014 and 2020 at the Regional Maternity Hospital of Nancy who who had not been exposed to antenatal steroid therapy. Two controls were selected for a case, appaired on the month and year of birth and on the sex of the case patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of an antenatal corticosteroid therapy on head growth. | head circumference | Birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of an antenatal corticosteroid therapy on fetal weight | birth weight | Birth | 
| Evaluate the impact of an antenatal corticosteroid therapy on fetal growth | birth lenght | birth | 
| Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient | APGAR score | birth | 
| Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia | hypoglycemia | first 5 days | 
| Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia | hypocalcemia | first 5 days | 
| Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth | day of hospitalisations after birth | first 5 days | 
| Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink) | eating disorders | first 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antenatal corticosteroid therapy, newborn, growth