The aim of this study is to investigate the effect of guided tapering in early pregnancy as compared to continuation of SSRIs during pregnancy. We will study effects on both mother and child with a pragmatic approach.
ID
Source
Brief title
Condition
- Other condition
- Maternal complications of pregnancy
- Mood disorders and disturbances NEC
Synonym
Health condition
effecten op kind na de geboorte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Risk of relapse of maternal depressive disorder (as defined by the Structured
Clinical Interview for DSM disorders) during pregnancy and up to 3 months
postnatal.
Secondary outcome
Mother:
- Time to relapse of depressive disorder up to 3 months after delivery.
- SSRI use and dosage, psychiatric co-medication (e.g. benzodiazepines),
adherence to preventive cognitive therapy
- Side effects of (tapering of) medication (checklist)
- Hazardous behavior (e.g. use of alcohol/drugs, suicidality)
- Stress, depressive symptoms, anxiety and childhood trauma
- Direct medical costs (until 3 months postpartum), indirect costs (with
adjustment for pregnancy leave period), quality of life effects mother
- Obstetric complications during pregnancy and delivery (spontaneous abortion,
referral midwife to obstetrician, preeclampsia [ISSHP definition], assisted
delivery, induced labour for maternal indication [premature, term delivery],
epidural anaesthesia for pain, caesarean section)
Child:
- Specific: child condition at birth (poor neonatal adaptation defined as:
5-min Apgar <7 and/or admission to pediatric ward/NICU)
- General: gestational age at birth, birth weight, head circumference at birth;
these measures also expressed as deviance scores/percentiles
- Neuromotor development (General Movements [GM])
- Child behavior (Child Behaviour Check List at 18 months; parental and
caregiver report)
- Direct medical costs, quality of life (proxy)
- Information from CJG about child behaviour at 2 years
Background summary
About 2% of pregnant women in the Netherlands use Selective Serotonin Reuptake
Inhibitors (SSRIs) during their pregnancy for symptoms of depression and/or
anxiety. SSRI use in pregnancy is controversial. On the one hand SSRIs may be
toxic to the intrauterine developing child, on the other hand, relapse of
depression and/or anxiety during pregnancy holds risks for both mother and
child. Among patients and professionals there is an urgent need for evidence
from randomized studies to make rational decisions regarding continuation or
tapering of SSRIs during pregnancy. No such studies exist to date.
Study objective
The aim of this study is to investigate the effect of guided tapering in early
pregnancy as compared to continuation of SSRIs during pregnancy. We will study
effects on both mother and child with a pragmatic approach.
Study design
A pragmatic, multicenter, randomized controlled trial with a 1:1 allocation.
Intervention
1. Preventive cognitive therapy with guided tapering of SSRIs
2. Continuation of SSRIs
Study burden and risks
Burden is minimal and consist of repeated questionnaires, a blood withdrawal
and a home visit 12 weeks after delivery. Both groups encounter the risk of
depressive relaps.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
< 16 weeks pregnant
SSRI use for depressive symptoms
Exclusion criteria
Multiple pregnancies
Severe medical conditions
Current relapse of depression
Current other severe psychiatric disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50164.078.14 |