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imPROving prenaTal carE During ConfinemenT (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368832
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, 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.

Condition or disease Intervention/treatment
Pregnancy Related COVID 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.

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: ImPROving prenaTal carE During ConfinemenT: Impact of Confinement on the Quality of Prenatal Care Perceived in Low-risk Pregnancy
Actual Study Start Date : April 25, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : September 30, 2021

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)



Primary Outcome Measures :
  1. Score of perceived quality of prenatal care [ Time Frame: 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 ]
    score obtained with the Quality of prenatal care questionnaire (QPCQ) as close as possible after release from containment


Secondary Outcome Measures :
  1. Level of stress during pregnancy [ Time Frame: 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 ]
    Perceived stress measured with Perceived Stress Scale-10 (PSS-10) scale

  2. level of health and digital literacy [ Time Frame: 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 evaluated with Health Literacy Questionnaire (HLQ) and eHealth Literacy Questionnaire (eHLQ) questionnaire

  3. Obstetrical outcomes [ Time Frame: Through study completion, an average of 6 months, ie at the end of postpartum care hospitalization ]
    core set of outcomes for maternity care

  4. Characteristics of medical supervision during pregnancy [ Time Frame: Through study completion, an average of 6 months, ie throughout the period of pregnancy ]
    Number of remote, face-to-face or emergency consultations during pregnancy and requester of each consultation (patient or practitioner)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368832


Locations
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France
Maternité Régionale Universitaire de Nancy
Nancy, France, 54035
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Gaëlle Ambroise CHRU Nancy
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04368832    
Other Study ID Numbers: 2020-A01023-36
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
COVID-19
containment measures