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临床试验/NCT04368832
NCT04368832已完成不适用

ImPROving prenaTal carE During ConfinemenT: Impact of Confinement on the Quality of Prenatal Care Perceived in Low-risk Pregnancy

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
Score of perceived quality of prenatal care

研究概览

简要总结

This study is a non-randomized, quasi-experimental, monocentric study comparing two prenatal monitoring modes in low-risk pregnancy: including at least one remote consultation (phone or teleconsultation) versus face-to-face adapted to confinement. The quality of care perceived by the pregnant women were evaluated according to monitoring modes set up during the COVID-19 pandemic confinement period. The women included planned to give birth at the regional academic Maternity of Nancy, France.

详细描述

The emergency confinement measures deployed by most industrialized countries governments to limit the impact of the coronavirus disease 2019(COVID-19) pandemic resulted in rapid and unpredictable changes in methods of obstetric monitoring. International and French government recommendations called for a reorganization of mandatory monitoring, particularly for low-risk pregnancies (limit the presence of the coparent during follow-up consultations and implement remote consultations). The potential impact of this reorganization on care perception, probably increased by the context of an unprecedented economic, social and health crisis, is unpredictable. In the absence of a previous event of comparable importance, it is impossible to anticipate differences in satisfaction with antenatal management and in stress level between women exposed to the two types of monitoring. Many factors can influence the perception of care quality, such as the socio-economic environment and the level of health literacy, that is, the individual's ability to find information on health, to understand and use this information to improve his own health or develop autonomy in health care system.

The objective of this study is to determine which type of monitoring is better perceived by pregnant women, the factors associated with this perception and the links with the level of knowledge and mastery of women regarding reproductive health and digital tools.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant woman eligible for type A or A1 follow-up according to the French Health Authority "Haute Autorité de Santé" (HAS) (low-risk pregnancy)
  • Having consulted at least one practitioner (midwife or physician) during the COVID-19 national confinement period
  • Gestational age > 7 weeks of amenorrhea on 17th March 2020, at the beginning of the national confinement period in France
  • having received complete information on the organisation of this research and not opposed to participation and exploitation of her data
  • Childbirth expected in the regional academic Maternity of Nancy
  • Member of or beneficiary of a social security scheme
  • Speaking French and able to complete a self questionnaire or having the possibility of being assisted

排除标准

  • Not understanding French
  • Multiple pregnancy
  • Request for voluntary termination of pregnancy
  • Discovery or suspicion of congenital malformation
  • Under protection of justice, guardianship or trusteeship
  • Deprived of liberty by judicial or administrative decision
  • Undergoing psychiatric care under sections L. 3212-1 and L. 3213-1 of french law (hospitalization without consent).

结局指标

主要结局

Score of perceived quality of prenatal care

时间窗: Through study completion, an average of 3 months, ie either at the beginning of the second or the third trimester of pregnancy, or during immediate postpartum care

score obtained with the Quality of prenatal care questionnaire (QPCQ) as close as possible after release from containment

次要结局

  • Level of stress during pregnancy(Through study completion, an average of 3 months, ie at the beginning of the second and the third trimester of pregnancy, and during immediate postpartum care)
  • level of health and digital literacy(Through study completion, an average of 3 months, ie at the beginning of the second and the third trimester of pregnancy, and during immediate postpartum care)
  • Obstetrical outcomes(Through study completion, an average of 6 months, ie at the end of postpartum care hospitalization)
  • Characteristics of medical supervision during pregnancy(Through study completion, an average of 6 months, ie throughout the period of pregnancy)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mme Gaëlle AMBROISE

Mrs

Central Hospital, Nancy, France

研究点 (1)

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