Trial Outcomes & Findings for Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic (NCT NCT04385238)

Results Overview

Post-traumatic Stress Disorder (PTSD) Symptoms will be assessed by the Impact of Events Scale-6. This scale includes a total of six items: two items from each of the three subscales of the measure, namely intrusion, hyperarousal and avoidance. Participants will be asked to report their PTSD symptoms in the past 7 days on a Likert Scale ranging from 0 (not at all) to 4 (extremely).

Recruitment status

COMPLETED

Target enrollment

6894 participants

Primary outcome timeframe

Anytime during pregnancy or within 6 months after given birth.

Results posted on

2021-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Pregnant Women Pregnant women who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.	Post-partum Women Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.
Overall Study STARTED	5712	1182
Overall Study COMPLETED	5712	1182
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Health and Wellbeing of Pregnant and Post-Partum Women During the COVID-19 Pandemic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Women n=5712 Participants Pregnant women who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.	Post-partum Women n=1182 Participants Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.	Total n=6894 Participants Total of all reporting groups
Age, Continuous	31.2 years STANDARD_DEVIATION 4.1 • n=5 Participants	31.7 years STANDARD_DEVIATION 4.9 • n=7 Participants	31.3 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	5712 Participants n=5 Participants	1182 Participants n=7 Participants	6894 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1288 Participants n=5 Participants	131 Participants n=7 Participants	1419 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4424 Participants n=5 Participants	1051 Participants n=7 Participants	5475 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Anytime during pregnancy or within 6 months after given birth.

Post-traumatic Stress Disorder (PTSD) Symptoms will be assessed by the Impact of Events Scale-6. This scale includes a total of six items: two items from each of the three subscales of the measure, namely intrusion, hyperarousal and avoidance. Participants will be asked to report their PTSD symptoms in the past 7 days on a Likert Scale ranging from 0 (not at all) to 4 (extremely).

Outcome measures

Outcome measures
Measure	Pregnant Women n=5712 Participants Pregnant women who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.	Post-partum Women n=1182 Participants Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.
Number of Participants With Symptoms of Post-traumatic Stress Disorder	1028 Participants	532 Participants

PRIMARY outcome

Timeframe: Anytime during pregnancy or within 6 months after given birth.

Symptoms of anxiety and depression will be measured by the Patient Health Questionnaire-4 (PHQ-4) which combines two ultrabrief screeners: the PHQ-2 and the Generalised Anxiety Disorder Scale. Participants will be asked to report their symptoms of depression and anxiety in the past 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day) for a maximum score of 12.

Outcome measures

Outcome measures
Measure	Pregnant Women n=5712 Participants Pregnant women who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.	Post-partum Women n=1182 Participants Women who gave birth within the last 6 months who are 18 years of age or older. This is an online survey with no intervention.: As this is an online survey about health and wellbeing, there is no intervention.
Number of Participants With Symptoms of Anxiety and Depression	1200 Participants	438 Participants

Adverse Events

Pregnant Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-partum Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sonia Hernandez-Diaz

Harvard T.H. Chan School of Public Health

Phone: 6174323942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60