Clinical trial NCT04368832: imPROving prenaTal carE During ConfinemenT
Official title: ImPROving prenaTal carE During ConfinemenT: Impact of Confinement on the Quality of Prenatal Care Perceived in Low-risk Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
COVID
Keywords: COVID-19
containment measures
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with low obstetrical risk expecting to give birth in the Maternité régionale universitaire de Nancy, France.

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.

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).

Primary outcomes:
measure: Score of perceived quality of prenatal care
timeFrame: 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
Secondary outcomes:
measure: Level of stress during pregnancy
timeFrame: 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
measure: level of health and digital literacy
timeFrame: 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
measure: Obstetrical outcomes
timeFrame: Through study completion, an average of 6 months, ie at the end of postpartum care hospitalization
measure: Characteristics of medical supervision during pregnancy
timeFrame: Through study completion, an average of 6 months, ie throughout the period of pregnancy
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternité Régionale Universitaire de Nancy
Study officials:
affiliation: CHRU Nancy
name: Gaëlle Ambroise
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avercenc L, Ngueyon Sime W, Bertholdt C, Baumont S, Freitas AC, Morel O, Guillemin F, Ambroise Grandjean G. Improving prenatal care during lockdown: Comparing telehealth and in-person care for low-risk pregnant women in the PROTECT pilot study. J Gynecol Obstet Hum Reprod. 2022 Nov;51(9):102445. doi: 10.1016/j.jogoh.2022.102445. Epub 2022 Jul 24.