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

Withdrawn

Conditions: prenatal anxiety/depression
prenatal stressful emotions
10028920
10037173

Registration Number: NL-OMON33601

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Pregnant women with a significant level of anxiety (6 item STAI ><=42) or at least moderate depressive symptoms (Edinburgh Postnatal Depression Scale ><=12) will be included in the trial.

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

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>