Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression (DEPRECOVID)

• ClinicalTrials.gov Identifier: NCT04368208
• Recruitment Status: Completed
• First Posted: April 29, 2020
• Last Update Posted: January 26, 2021
• Sponsor: Poitiers University Hospital
• Information provided by (Responsible Party): Poitiers University Hospital

Study Description

Brief Summary:

Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health.

The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression.

It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.

Condition or disease	Intervention/treatment
Postnatal Depression	Other: Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery

Study Design

• Study Type: Observational
• Actual Enrollment: 501 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression
• Actual Study Start Date: April 29, 2020
• Actual Primary Completion Date: October 21, 2020
• Actual Study Completion Date: November 27, 2020

Groups and Cohorts

Intervention Details:

• Other: Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery
  The Edinburgh questionnaire is a self questionnaire validated for postnatal depression between 4 and 6 weeks postnatal
  Other Names:

  • Assessment of satisfaction about childbirth using the WOMBLSQ4 questionnaire within the week after delivery
  • Retrospective assessment of prenatal anxiety within the week after the delivery
  • Assessment of pelvic floor disorders using the PFDI questionnaire between 4 and 6 weeks after delivery
  • Assessment of self rated health for the woman and the child using the WHO question about self rated health between 4 and 6 weeks after delivery

Outcome Measures

Primary Outcome Measures :

1. Report postnatal depression between 4 of 6 weeks during the covid 19 pandemia [ Time Frame: 4-6 weeks postpartum ]
   proportion of women with an Edinburgh score higher than 12 between 4 and 6 weeks postpartum

Secondary Outcome Measures :

1. Report factors associated with postnatal depression between 4 of 6 weeks during the covid 19 pandemia [ Time Frame: 4-6 weeks postpartum ]
   Existence of an association with postnatal depression and these factors: socio demographic women's characteristics, modalities of pregnancy management, satisfaction and experience about delivery, postnatal pelvic floor disorders, self rated health for the woman and the child, modalities of delivery, prenatal anxiety
2. Describe the experience and the satisfaction about delivery during the covid 19 pandemia [ Time Frame: within the week after delivery ]
   Scale from 0 to 10 of satisfaction ; answers to the WOMBLSQ4 questionnaire about childbirth experience and satisfaction

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Sampling Method: Non-Probability Sample

Study Population

Women who deliver of a single baby, at term and in cephalic presentation whatever is the modalities of delivery (instrumental, cesarean, spontaneous delivery) will be included after their delivery.

Premature and non cephalic birth will be excluded because they are specific deliveries that may be assoictaed with a specific maternal anxietey. Women with psychiatric disorders are excluded since we investigated the occurrence of postnatal depression which is a psychiatric disorder.

Women without any internet access are excluded because women will have to fill online questionnaires. Finally women will be informed, as well as their doctors, in case of postnatal depression with an advice of planning a medical consultation.

Criteria

Inclusion Criteria:

• women older than 18 years
• women who deliver of a singleton, term neonate in cephalic presentation

Exclusion Criteria:

• women younger than 18 years
• women who deliver of a baby in non cephalic presentation
• women with pre term Birth
• women without any internet access
• women with psychiatric disorders
• women who do not understand french language
• women who refuse to be aware of the results of the postnatal depression screening and who refuse that her doctor be ware of the results

Contacts and Locations

Locations

France

Bertrand GACHON

Poitiers, France

Sponsors and Collaborators

Poitiers University Hospital

More Information

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT04368208
• Other Study ID Numbers: 2020-A01065-34
• First Posted: April 29, 2020
• Last Update Posted: January 26, 2021
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:

childbirth; covid 19; satisfaction

Additional relevant MeSH terms:

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