Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Central Hospital, Nancy, France

Status: Completed

Conditions: Growth Retardation

Treatments: Drug: Betamethasone

Study type: Observational

Funder types: Other

Identifiers

NCT05640596

2021PI166

Details and patient eligibility

About

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.

Full 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.

Enrollment: 363 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

363 participants in 2 patient groups

exposed group (121 patients)

Description:

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.

Treatment:

Drug: Betamethasone

nonexposed group (242 patients)

Description:

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.