Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

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.

Study Overview

• Status: Completed
• Conditions: Growth Retardation
• Intervention / Treatment: Drug: Betamethasone

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 Type: Observational
• Enrollment (Actual): 363

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Betamethasone
nonexposed group (242 patients); 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?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: growth; newborn; Antenatal corticosteroid therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 2021PI166