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PROMISES


Pregnancy Outcomes after Maternity Intervention for Stressful Emotions

 

Go to the Promises website
Go to the
P5D website


Introduction
PROMISES stands for Pregnancy Outcomes after Maternity Intervention for Stressful Emotions. In other words, how is the development of the children of women who have suffered from symptoms of depression and/or anxiety during pregnancy? And what will happen regarding the psychosocial development of the child and the mother when we offer therapy to these women, during pregnancy?

Rationale:
There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. To date, however, no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease.

Objective:
To assess the effects of Cognitive Behavioral Therapy (CBT) in pregnant women with symptoms of anxiety or depression on the child's behavioral/emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of CBT relative to usual care.

Study design:
Single blind randomized controlled trial.

Study population:
300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women we will be able to demonstrate effect sizes of 0.35 or over on the total problems scale of the CBCL 1.5-5 with alpha 5% and power (1-beta) 80%.

Intervention:
10-14 individual CBT sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week), or care as usual.

Main study parameters/endpoints:
Primary:

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

Secondary:

  • 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).

Procedure of the research
Gynecologists/midwives/research nurses offer an information package about the screening study (P5D) to every pregnant woman during the first or second consult (before 15 weeks of pregnancy). This package contains a brochure showing information about the research and a questionnaire. This questionnaire holds, among others, questions about anxiety and depression complaints, social support and personality.
When the participant scores above the cut-off value for at least moderate levels of anxiety or depression (STAI 13, EPDS 12), she receives an information leaflet and a card to indicate whether they want to participate. Meanwhile, the gynecologist or nurse provides information on the PROMISES study and gives the opportunity to ask questions about the research. All women have a period of two weeks to think about their participation. When they send the card back, the research team of the UMC Groningen makes an appointment to answer (more) questions and to take a diagnostic interview.
In short, except from the inclusion, the complete study will be executed by the UMC Groningen.

Exclusion criteria:
Women fulfilling one or more of the following criteria will be excluded from participation:

  1. Multiple pregnancies. 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
  6. Having a psychiatric history on bipolar disorder, psychoses and manic disorder. 
  7. IVF history

Time schedule:
After inclusion, follow-up takes 6 months during pregnancy and 18 months following delivery, 24 months in total.

Investigators
C. Beijers, Msc.
J.L. Meijer, Msc.
T. Verbeek, BSc.

Projectleader
Dr. H. Burger, M.D., Ph.D., UMC Groningen

Contact
Universitair Medisch Centrum Groningen
Afdeling Epidemiologie
HPC: FA40
Postbus 30001
9700 RB Groningen
Mail:
promises@studies-obsgyn.nl
Tel: 050-3611450