A Study of Postpartum Depression, Nutrition, and Neonatal Physical Development.

JRCT ID: jRCT1030230692

Registered date:12/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Postpartum depression
• Date of first enrollment: 12/03/2024
• Target sample size: 45
• Study type: Interventional
• Intervention(s): For cases in which depression was observed in observational studies, a multidisciplinary team (PMST) intervention including maternal and neonatal nutritional management (symptoms of depression, nutritional status of mother and neonate, and psychosocial factors are assessed over time and information is shared, followed by standard psychiatric treatment according to patient and family needs (according to the Japan Depression Society guidelines ), nutritional guidance, and social support according to the needs of the patient and family. The PMST intervention will be conducted in collaboration with community health nurses and midwives (if necessary, to establish a support system for childcare and mothers after discharge from the hospital), and the effects of the PMST intervention on depressive symptoms will be clarified through a before-and-after comparison using HAMD scores as the primary outcome measure. In addition, maternal nutritional assessment, blood tests, and newborn physical growth assessment will be continued and compared with normal Japanese newborn development.

Outcome(s)

• Primary Outcome: Hamilton Depression Rating Scale

Secondary Outcome

Structured Clinical Interview for DSM-5; semi-structured interview by SCID
Physical measurements such as maternal height, weight, Body Mass Index, triceps subcutaneous fat thickness, brachialis muscle circumference, and brachialis muscle area calculated from these measurements.
Blood tests (total plasma protein, albumin, and total cholesterol), blood counts, and additional tests (fatty acids; EPA, DHA, vitamins; B1, B6, B12, folic acid, amino acids and proteins; tryptophan, homocysteine, ferritin, inorganic substances; Fe, Zn, Mg, Cu, Se, etc.)
Neonatal physical growth assessment (height, weight, head position, chest circumference)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female
• Include criteria: Patients diagnosed as "depressed" in a previous observational study on postpartum depression, nutrition and neonatal physical development.

Exclude criteria

Persons with impaired consciousness.
Patients whose depression cannot be assessed by questionnaires or interviews due to serious physical illness.
Patients with psychiatric disorders other than depression, such as schizophrenia.
Other subjects deemed inappropriate by the Principal Investigator or co-investigators.

Related Information

• Primary Sponsor: Yamamoto Kenji