Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Completed

• Conditions: Growth Retardation
• Interventions: Drug: Betamethasone

• Registration Number: NCT05640596
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2020-12-31
• Study First Submitted: 2022-07-12
• Study Completion: 2022-11-25
• Study First Submitted QC: 2022-11-28
• Status Verified: 2022-12
• Study First Posted: 2022-12-07
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exposed group (121 patients)	Betamethasone	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.

Primary Outcome Measures

Name	Time	Method
Evaluate the impact of an antenatal corticosteroid therapy on head growth.	Birth	head circumference

Secondary Outcome Measures

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