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Maternal Mental Health Trial

RecruitingPhase 1, Phase 2Ages 18 Years - 45 YearsFemaleVibe G Frøkjær, MD, PhD
NCT04685148 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Perinatal depression affects 10-15% of women postpartum and has a recurrence rate of 40%. Women who develop perinatal depression might be particularly susceptible to the rapid and large changes in sex steroid hormones, particularly estradiol, across pregnancy to postpartum. This trial aims 1) to evaluate the preventive effect of transdermal estradiol treatment in the immediate postpartum on depressive episodes in a subgroup of women at high-risk for perinatal depression, and 2) to determine if a set of biomarker gene transcripts can identify this subgroup and thus form the basis for future personalised prevention or treatment. The MAMA Trial is a double-blind, 1:1 randomised, placebo-controlled trial. The trial involves maternity wards at three university hospitals in the Capital Region of Denmark. Women who are singleton pregnant in the third trimester with a prior history of perinatal

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📋 Eligibility rules (as published)
Inclusion Criteria: * Singleton pregnant * Prior history of perinatal depression * Age between 18 and 45 years Exclusion Criteria: * Moderate to severe depression with onset during pregnancy * Severe psychiatric disorders (e.g. disorders with psychotic symptoms, schizophrenia, bipolar disorders, inpatient eating disorders and inpatient obsessive-compulsive disorders) * Previous suicide attempts without having a depressive episode * Prior history or ongoing neurological disorders (e.g. migraine or epilepsy) * Severe somatic illness * Prior history or ongoing cancer * Prior history of venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or thrombophilia, or other risk factors clinically assessed after thrombophilia screening * Deep vein thrombosis or pulmonary embolism in current pregnancy * Pregnancy-induced hypertension or preeclampsia * Pre-existing atherosclerosis or well-known cardiovascular risk factors (e.g. diabetes, hypertension) * Other contraindication for oestrogen treatment (e.g. acute liver failure, severe varicose veins) * Use of psychotropic pharmacology, except for short-term sleep support treatment * Non-fluent in Danish or pronounced vision or hearing loss * Body Mass Index (BMI) \>35 kg/m2 * Ongoing alcohol or drug abuse * Severe postpartum haemorrhage (\>1500 ml) * Severe illness in the infant or perinatal death
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What it tests

  • Transdermal patch estradiol
  • Transdermal patch placebo
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Where

1 site
Neurobiology Researc hUnit
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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