The Role of Sex Steroids and Serotonin Brain Dynamics in Perinatal Mental Health

Plain-language summary

This observational study investigates the role of sex steroid hormones and serotonin brain dynamics in mental health around the time of childbirth (perinatal mental health). Healthy pregnant women aged 18 to 40 who were planned to deliver by caesarean section were able to take part. This was a phase-not-applicable study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Vibe G Frøkjær, MD, PhD

Intervention

Pregnancy

Start date

1/24/2019

Estimated completion

12/1/2020

Countries

Denmark

Related genes

Locations

• Copenhagen, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Age 18-40 years
* Healthy pregnant women planned to deliver by caesarean section due to breech position of the fetus or previous caesarean section.

Exclusion Criteria:

* Current or previous severe psychiatric disorder such as psychotic disorders, eating disorder and bipolar disorder or current or previous psychiatric disorder requiring hospitalization.
* Current or previous neurological diseases, severe somatic disease, severe postpartum hemorrhage or use of medication that can interfere with study outcomes
* Severe disease or malformations in infants
* Obesity or underweight (pre-gestational BMI below 18 or above 35)
* Not fluent in Danish or severe visual or hearing impairments
* Earlier or present learning disabilities
* MRI contraindications (claustrophobia, metal implants)
* Previous exposure to radioactivity \> 10 millisievert (mSv) within the last year
* Alcohol or drug abuse