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Completed

NCT Number: NCT05640596

Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

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.

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Key information

Conditions

Growth Retardation

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Betamethasone

Drug

Primary outcomes

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

    Time frame: Birth

    head circumference

Secondary outcomes

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

    Time frame: Birth

    birth weight

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

    Time frame: birth

    birth lenght

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

    Time frame: birth

    APGAR score

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

    Time frame: first 5 days

    hypoglycemia

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

    Time frame: first 5 days

    hypocalcemia

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

    Time frame: 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)

    Time frame: first 5 days

    eating disorders

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2022
First posted
Dec 7, 2022
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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