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Clinical Trials/NCT04368832
NCT04368832
Completed
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country108 target enrollmentApril 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Central Hospital, Nancy, France
Enrollment
108
Locations
1
Primary Endpoint
Score of perceived quality of prenatal care
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2020
End Date
November 17, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Mme Gaëlle AMBROISE

Mrs

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Score of perceived quality of prenatal care

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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