imPROving prenaTal carE During ConfinemenT

NCT ID: NCT04368832

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-25
• Study Completion Date: 2020-11-17

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.

Conditions

Pregnancy Related; COVID

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental group

During prenatal monitoring, at least one consultation by remote consultation (phone or teleconsultation)

Remote consultation

Intervention Type: OTHER

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

Control group

Prenatal monitoring by face-to-face consultations adapted to confinement (absence of clinical signs or notion of travel, occupation, contact, clustering (TOCC), no attendant, limited movements inside the hospital and precautions of "droplet" and "contact" type)

No interventions assigned to this group

Interventions

Remote consultation

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Mme Gaëlle AMBROISE

Mrs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaëlle Ambroise

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

Maternité Régionale Universitaire de Nancy

Nancy, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35882366 (View on PubMed)

Other Identifiers

2020-A01023-36

Identifier Type: -

Identifier Source: org_study_id