Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS (PROMISES)

Completed

• Conditions: prenatal anxiety/depression; prenatal stressful emotions; 10028920; 10037173

• Registration Number: NL-OMON38046
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

Having at least moderate depression and/or anxiety symptoms during pregnancy.

Exclusion Criteria

Women fulfilling one or more of the following criteria will be excluded from participation:
1. High suicidal risk according to the suicidality subscale score on the MINI (defined as a positive response on the question on concrete suicide plans)
2. Presently receiving psychotherapy at a higher than twice a month rate
3. Substantial physical disease or illegal substance abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Behavioral/emotional problems at age 1.5 as assessed by the total problems<br /><br>scale of the Child Behavior Check List 1.5 - 5 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Mental, psychomotor and behavioral development of the child at age 18 months<br /><br>according to the Bayley scales<br /><br>- Maternal anxiety and depression during pregnancy and 6 weeks postnatal<br /><br>- Maternal attachment style<br /><br>- Neonatal outcomes: birth weight, gestational age and Apgar score<br /><br>- Health care consumption and general health status (economic evaluation).</p><br>