Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

NCT05640596 | Completed

• 1 other identifier: 2021PI166
• Study Type: observational
• Target: 363
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Retardation

Keywords

Antenatal corticosteroid therapy; newborn; growth

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of an antenatal corticosteroid therapy on head growth.

  head circumference

  Birth

Secondary Outcomes (7)

• 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 hypoglycemia : number of patients with neonatal hypoglycémia

  first 5 days

• Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia

  first 5 days

Study Arms (2)

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.

Interventions

Betamethasone DRUG

exposed group (121 patients)

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea because of a threat of premature delivery
• only full-term newborns

You may not qualify if:

• all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• Best C, Hascoet JM, Jeanbert E, Morel O, Baumann C, Renard E. Impact of corticosteroid exposure on preterm labor in neonates eventually born at term. J Perinatol. 2024 Feb;44(2):195-202. doi: 10.1038/s41372-023-01831-0. Epub 2023 Dec 1.

  PMID: 38040875 DERIVED

MeSH Terms

Interventions

Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: December 7, 2022
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: November 25, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12