Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05640596
Collaborator
(none)
363
106.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
363 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Nov 25, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate the impact of an antenatal corticosteroid therapy on head growth. [Birth]

    head circumference

Secondary Outcome Measures

  1. Evaluate the impact of an antenatal corticosteroid therapy on fetal weight [Birth]

    birth weight

  2. Evaluate the impact of an antenatal corticosteroid therapy on fetal growth [birth]

    birth lenght

  3. Evaluate the impact of an antenatal corticosteroid therapy on neonatal adaptation : APGAR score for each patient [birth]

    APGAR score

  4. Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia [first 5 days]

    hypoglycemia

  5. Evaluate the impact of an antenatal corticosteroid therapy on risk of hypocalcemia : number of patients with hypoglycemia [first 5 days]

    hypocalcemia

  6. 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

  7. Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink) [first 5 days]

    eating disorders

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Months
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RENARD Emeline, Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05640596
Other Study ID Numbers:
  • 2021PI166
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Keywords provided by RENARD Emeline, Doctor, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 12, 2022