Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
Overview
- Phase
- Not Applicable
- Intervention
- Betamethasone
- Conditions
- Growth Retardation
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 363
- Primary Endpoint
- Evaluate the impact of an antenatal corticosteroid therapy on head growth.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
RENARD Emeline
Doctor
Central Hospital, Nancy, France
Eligibility Criteria
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
Arms & Interventions
exposed group (121 patients)
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.
Intervention: Betamethasone
Outcomes
Primary Outcomes
Evaluate the impact of an antenatal corticosteroid therapy on head growth.
Time Frame: Birth
head circumference
Secondary Outcomes
- Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia(first 5 days)
- Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth(first 5 days)
- Evaluate the impact of an antenatal corticosteroid therapy on fetal weight(Birth)
- Evaluate the impact of an antenatal corticosteroid therapy on fetal growth(birth)
- Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient(birth)
- Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia(first 5 days)
- Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink)(first 5 days)