Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Growth Retardation Clinical Trial

Official title:

Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05640596
• Other study ID #: 2021PI166
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: November 25, 2022

Study information

• Verified date: December 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: November 25, 2022
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Growth Retardation

Intervention

Drug:
• Betamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the impact of an antenatal corticosteroid therapy on head growth.	head circumference	Birth
Secondary	Evaluate the impact of an antenatal corticosteroid therapy on fetal weight	birth weight	Birth
Secondary	Evaluate the impact of an antenatal corticosteroid therapy on fetal growth	birth lenght	birth
Secondary	Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient	APGAR score	birth
Secondary	Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia	hypoglycemia	first 5 days
Secondary	Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia	hypocalcemia	first 5 days
Secondary	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
Secondary	Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink)	eating disorders	first 5 days