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Maternal Mental Health Trial

NCT04685148 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-09-23

No results posted yet for this study

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%.

Conditions

Interventions

DRUG

Transdermal patch estradiol

Estradiol patches (200 μg per day by transdermal delivery) will be administered at day 0 (+1) to day 21 postpartum.

DRUG

Transdermal patch placebo

Placebo patches will be administered at day 0 (+1) to day 21 postpartum.

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Vibe G Frøkjær, MD, PhD

    lead OTHER

Principal Investigators

  • Vibe Gedsø Frøkjær, MD, PhD · Neurobiology Research Unit, copenhagen University hospital, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685148 on ClinicalTrials.gov