imPROving prenaTal carE During ConfinemenT

NCT04368832 | Completed

• 1 other identifier: 2020-A01023-36
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; COVID

Keywords

COVID-19; containment measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 Arms (2)

Experimental group

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

Other: Remote consultation

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)

Interventions

Remote consultation OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternité Régionale Universitaire de Nancy

Nancy, 54035, France

Location

Related Publications (1)

• 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.

  PMID: 35882366 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• Gaëlle Ambroise

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 30, 2020
• Study Start: April 25, 2020
• Primary Completion: November 17, 2020
• Study Completion: November 17, 2020
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

FR (1)