Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship

• Conditions: Covid19; Delivery; Trauma

• Registration Number: NCT04609501
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females. In this study, we aimed to evaluate the relations between the fear of COVID-19 and postnatal depression symptoms.

Detailed Description

This is a multicenter prospective cohort study of childbearing women during COVID-19. Participants completed a comprehensive online questionnaire including demographic, socioeconomic, obstetric, and postnatal mental-health questionnaires. Data were verified with each center's perinatal database and information regarding physiological stress during pregnancy/birth was also collected. Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale and postnatal depression was evaluated using the EPDS. Pre-existing maternal disability was defined as prior physiological or psychological chronic health condition.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 440

Inclusion Criteria

• women who delivered during the Covid-19 pandemic at the site, since 01-March-2020

Exclusion Criteria

• women age 18 and below
• Gestational age under 34 weeks
• Intra Uterine Fetal Demise
• Ante-partum Fetal Demise
• Maternal post partum death

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relations between fear of COVID-19 and postnatal depression symptoms.	1 year after delivery	Postnatal depression was evaluated using the EPDS.
Evaluation of COVID-19 during pregnancy	1 year after delivery	Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center; 🇮🇱 Hadera, Israel