CClinicalTrials.gg
CompletedNCT05640596Updated Dec 12, 2022

Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

An observational study in Growth Retardation, sponsored by Central Hospital, Nancy, France. Completed. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
363
Ages
Up to 12 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Growth Retardation

Keywords

  • Antenatal corticosteroid therapy
  • newborn
  • growth
03

In context

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
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.

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

Exclusion Criteria:

  • all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
363 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugBetamethasone
06

What researchers measure

Primary outcomes

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

    head circumference

    Time frame: Birth

Secondary outcomes

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

    birth weight

    Time frame: Birth

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

    birth lenght

    Time frame: birth

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

    APGAR score

    Time frame: birth

  4. Evaluate the impact of an antenatal corticosteroid therapy on risk of hypoglycemia : number of patients with neonatal hypoglycémia

    hypoglycemia

    Time frame: first 5 days

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

    hypocalcemia

    Time frame: first 5 days

  6. Evaluate the impact of an antenatal corticosteroid therapy on neonatal outcome : number of days of hospitalisation after birth

    day of hospitalisations after birth

    Time frame: first 5 days

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

    eating disorders

    Time frame: first 5 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05640596
Lead sponsor
Central Hospital, Nancy, France
Responsible party
RENARD Emeline (Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Dec 7, 2022
Start date
Jan 1, 2014
Primary completion
Dec 31, 2020
Completion
Nov 25, 2022
Last update
Dec 12, 2022
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion