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Maternal Mental Health (MAMA) Study. Short time treatment with female sex hormone to prevent postpartum depression in a high-risk group
EU CTIS ID: 2024-518028-63-00
What this study is testing
To evaluate if short-term estradiol administration relative to placebo in the immediate postpartum period (day 0 to day 21) prevents depressive episodes in women with a history of postpartum depression
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women between 18 and 45 years and pregnant in the third trimester.
- Previously perinatal depression with the onset of depressive episode in pregnancy or within 6 months of birth or untreated depressive episode assessed by retrospective interview by healthcare professional.
You likely can't join if
- Antidepressant treatment by inclusion in the study.
- Pregnancy-related hypertension or preeclampsia.
- Manifest atherosclerosis or known cardiovascular risk factors (including diabetes, hypertension).
- Other contraindication for estrogen treatment (e.g. acute liver disease, varicicated varicencies).
- Use of psychotropic pharmacology, except for short-term sleep support treatment, which is likely to influence the results of the study.
- Non-fluent in Danish or pronounced vision or hearing loss.
See the full eligibility criteria
- Women between 18 and 45 years and pregnant in the third trimester.
- Previously perinatal depression with the onset of depressive episode in pregnancy or within 6 months of birth or untreated depressive episode assessed by retrospective interview by healthcare professional.
- Antidepressant treatment by inclusion in the study.
- Pregnancy-related hypertension or preeclampsia.
- Manifest atherosclerosis or known cardiovascular risk factors (including diabetes, hypertension).
- Other contraindication for estrogen treatment (e.g. acute liver disease, varicicated varicencies).
- Use of psychotropic pharmacology, except for short-term sleep support treatment, which is likely to influence the results of the study.
- Non-fluent in Danish or pronounced vision or hearing loss.
- Current or previous learning difficulties.
- BMI >35 kg/m2.
- Current alcohol or drug abuse.
- Multiple pregnancy.
- Severe postpartum haemorrhage (>1500 ml).
- Moderate to severe depression developed in pregnancy before day 0 postpartum.
- Serious illness or neonatal death in the child.
- Severe mental illness, e.g. diseases of the schizophrenic spectrum, psychotic conditions, inpatient active eating disorder or hospitalising OCD, and bipolar affective disorder.
- Previous suicide attempts outside the depressive episode.
- Present or previous neurological disease including migraines and epilepsy.
- Severe medical disease.
- Past or ongoing cancer.
- Previous venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or known thrombophilic diseases and risk factors clinically assessed after thrombophilic screening.
- Deep vein thrombosis or pulmonary embolism in current pregnancy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.