Skip to main content
OpenTrials
Completed

NCT Number: NCT04348929

Birth Experience During COVID-19 Confinement

Different studies have demonstrated that the absence of companionship during labor and childbirth may be responsible for a negative birth experience, an increased risk of postnatal depression and/or post traumatic stress disorders. These situation may also have a negative impact on mother-child interaction, on marital and family relationship and on the rate of maternal suicide in postpartum. However, these previous results cannot be extrapolated in the current context where the absence of the companionship is imposed by the confinement framework. The objective of the CONFINE study is to assess, for the first time, the birth experience of women in the context of limited social support in the immediate post-partum period due to confinement, as well as the associated over-risk of mental disorders, compared to a post-partum without social restriction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postpartum Depression COVID-19 Coronaviridae Infections Coronavirus Infections Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Mental Disorders Mood Disorders Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Complications Puerperal Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54000, France

About this study

The primary objective is to compare, in immediate post-partum, the maternal sense of control during childbirth between a group of women who gave birth during confinement ("confinement" group) versus a group of women who gave birth after confinement but in the context of epidemic ("epidemic" group) versus a group of control women ("control" group; excluding confinement and context of epidemic).

The secondary objectives are:

  • To compare, at two months post-partum, the maternal sense of control during childbirth between the three groups.
  • To compare, at two months of post-partum, scoring of self-questionnaire Edinburg Postnatale Depression Scale (EPDS) for the post-natal depression between the three groups.
  • To compare at two months of post-partum, scoring of self-questionnaire Impact of Event Scale - Revised (IES-R) for posttraumatic stress disorder, between the three groups.
  • To compare, at two months of post-partum, the breastfeeding between the three groups.
  • To compare, at two months of post-partum, the quality of life (SF-12) between the three groups.
  • To compare the evolution of quality of life at two months of post-partum between the three groups.
  • To compare the rate of post-natal depression between the three groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Woman who is >= 18 years old
  • Woman having just given birth from 37 weeks of gestation (singleton pregnancy)
  • Woman affiliated to a social security
  • Woman with a level of understanding of written French sufficient to answer the questionnaires.
  • Woman having received complete information on the organization of the research and having given her informed consent in written form.

Specific inclusion criteria according to the group For "confinement"group : Delivery during covid-19 confinement period

For "epidemic" group: Delivery after confinement period and before the withdrawal of sanitary measures implemented (mask, social distancing, limited visits during post-partum immediate)

For "control" group: Start of pregnancy after confinement and delivery after the withdrawal of all sanitary measures (mask, social distancing, limited visits during post-partum immediate)

Exclusion criteria

  • Major mentioned in articles L.1121-6 and L-1121-8 of Health Public Code.
  • Woman with psychiatric disorders such as depressive syndrome
  • Woman considered positive for covid-19 and treated as such at the time of delivery (regardless of test result)
  • Newborn with congenital abnormalities
  • Stillbirth

Treatment and study plan

self-administered questionnaires

Other

Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home)

Primary outcomes

  1. "Labor Agentry Scale questionnaire" score in immediate post-partum (duration of hospital stay)

    Time frame: through study completion, an average of 16 months

Secondary outcomes

  1. "Labor Agentry Scale questionnaire" score at two months after birth

    Time frame: through study completion, an average of 16 months

  2. Edinburg Postnatale Depression Scale questionnaire" score at two months after birth

    Time frame: through study completion, an average of 16 months

    To detect suspicion of Post-Partum Depression

  3. "Impact of Event Scale - Revised questionnaire" score at two months after birth

    Time frame: through study completion, an average of 16 months

    To detect suspicion of Post traumatic stress syndrome

  4. Breastfeeding statement at two months after birth

    Time frame: through study completion, an average of 16 months

  5. "SF-12 Quality of life questionnaire" score at two months after birth

    Time frame: through study completion, an average of 16 months

  6. "SF-12 Quality of life questionnaire" score in immediate post-partum

    Time frame: through study completion, an average of 16 months

  7. Diagnosis of post-natal depression (made by a specialist)

    Time frame: through study completion, an average of 16 months

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)

Acronym: CONFINE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.