Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 363
- 主要终点
- Evaluate the impact of an antenatal corticosteroid therapy on head growth.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea because of a threat of premature delivery
- •only full-term newborns
排除标准
- •all children exposed to an antenatal corticosteroid therapy before 34 weeks of amenorrhea for other reasons
研究组 & 干预措施
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.
干预措施: Betamethasone (Drug)
结局指标
主要结局
Evaluate the impact of an antenatal corticosteroid therapy on head growth.
时间窗: Birth
head circumference
次要结局
- 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 neonatal outcome : number of days of hospitalisation after birth(first 5 days)
- 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 hypocalcemia : number of patients with hypoglycemia(first 5 days)
- Evaluate the impact of an antenatal corticosteroid therapy on eating disorders (number of patients with difficulty to drink)(first 5 days)
研究者
RENARD Emeline
Doctor
Central Hospital, Nancy, France