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Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS (PROMISES)

Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS (PROMISES) - Maternity intervention for stressful emotions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38046
Enrollment
300
Registered
2009-10-13
Start date
2009-10-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prenatal anxiety/depression prenatal stressful emotions

Interventions

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Behavioral/emotional problems at age 1.5 as assessed by the total problems scale of the Child Behavior Check List 1.5 - 5 years.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)