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Pregnancy Outcomes after Maternity Intervention for Stressful EmotionS - study(PROMISES)

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33601
Enrollment
300
Registered
2010-01-04
Start date
Unknown
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: Pregnant women with a significant level of anxiety (6 item STAI >

Exclusion criteria

Exclusion criteria: Women fulfilling one or more of the following criteria will be excluded from participation: 1. Multiple pregnancy. We decided to exclude women with multiple pregnancies as they have a markedly increased obstetric risk; inclusion will threaten the homogeneity of the study population and thereby decrease the sensitivity to detect effects. 2. High suicidal risk according to the suicidality subscale score on the MINI (defined as a positive response on the question on concrete suicide plans) 3. Presently receiving psychotherapy 4. Substantial physical disease or illegal substance abuse 5. No mastery of the Dutch language

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)