imPROving prenaTal carE During ConfinemenT (PROTECT)

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; COVID
• Intervention / Treatment: Other: Remote consultation

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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54035
    • Maternité Régionale Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; During prenatal monitoring, at least one consultation by remote consultation (phone or teleconsultation)	Other: Remote consultation; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of perceived quality of prenatal care	score obtained with the Quality of prenatal care questionnaire (QPCQ) as close as possible after release from containment	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of stress during pregnancy	Perceived stress measured with Perceived Stress Scale-10 (PSS-10) scale	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	level of health and digital literacy evaluated with Health Literacy Questionnaire (HLQ) and eHealth Literacy Questionnaire (eHLQ) questionnaire	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	core set of outcomes for maternity care	Through study completion, an average of 6 months, ie at the end of postpartum care hospitalization
Characteristics of medical supervision during pregnancy	Number of remote, face-to-face or emergency consultations during pregnancy and requester of each consultation (patient or practitioner)	Through study completion, an average of 6 months, ie throughout the period of pregnancy

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Gaëlle Ambroise, CHRU Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2020
• Primary Completion (ACTUAL): November 17, 2020
• Study Completion (ACTUAL): November 17, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (ACTUAL): April 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; containment measures
• Other Study ID Numbers: 2020-A01023-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No