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imPROving prenaTal carE During ConfinemenT

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04368832
Acronym
PROTECT
Enrollment
108
Registered
2020-04-30
Start date
2020-04-25
Completion date
2020-11-17
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID, Pregnancy Related

Keywords

COVID-19, containment measures

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.

Interventions

OTHERRemote consultation

One or more consultation is conducted by phone or teleconsultation during prenatal monitoring

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Score of perceived quality of prenatal careThrough 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 carescore obtained with the Quality of prenatal care questionnaire (QPCQ) as close as possible after release from containment

Secondary

MeasureTime frameDescription
Level of stress during pregnancyThrough study completion, an average of 3 months, ie at the beginning of the second and the third trimester of pregnancy, and during immediate postpartum carePerceived stress measured with Perceived Stress Scale-10 (PSS-10) scale
level of health and digital literacyThrough study completion, an average of 3 months, ie at the beginning of the second and the third trimester of pregnancy, and during immediate postpartum carelevel of health and digital literacy evaluated with Health Literacy Questionnaire (HLQ) and eHealth Literacy Questionnaire (eHLQ) questionnaire
Obstetrical outcomesThrough study completion, an average of 6 months, ie at the end of postpartum care hospitalizationcore set of outcomes for maternity care
Characteristics of medical supervision during pregnancyThrough study completion, an average of 6 months, ie throughout the period of pregnancyNumber of remote, face-to-face or emergency consultations during pregnancy and requester of each consultation (patient or practitioner)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026