Maternal Mental Health Trial

• Status: Recruiting
• Trial end date: 2030-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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 depression are eligible to participate. Participants will be randomised to either estradiol patches (200 μg per day) or placebo patches for three weeks starting immediately postpartum.

The primary statistical analysis will be performed based on the intention-to-treat principle. A sample size of 220 will provide the trial with 80% power (alpha 0.05, beta 0.2) to detect a reduction in postpartum depression of 50% and to tolerate a drop-out of around 20%.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vibe G Frøkjær, MD, PhD
• Collaborators: Herlev Hospital; Hvidovre University Hospital
• Treatments: Estradiol

Criteria

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