The purpose of this study is to test a new treatment for preventing childbirth-related mental illness in postpartum mothers. The treatment is aimed at enhancing maternal bonding, reducing postpartum depression (PPD) and anxiety in mothers at risk, and promoting child development. To this end, the investigators will test the clinical utility of intranasal (IN) oxytocin (OXT) administered to mothers during the first postpartum days.
Postpartum depression (PPD) is a debilitating disorder which imposes a threat to mother and infant health. An estimated 600,000 American women suffer from PPD annually, making it one of the most frequent complications of pregnancy. Available secondary preventive interventions are often ineffective, which calls for identifying novel means for prevention. Impaired mother-infant bonding is a hallmark of PPD. Depressed mothers may have difficulties developing maternal feelings and providing sensitive care. In turn, impaired bonding may worsen mother's depression. Conventional pharmacotherapy does not help with bonding impairment. This study will attempt to fill in the current gap in effective preventive interventions for pregnant mothers at risk. Evidence in postpartum mothers indicates that high peripartum OXT levels are associated with enhanced maternal behavior and low levels with depression. Data also indicates that in depressed mothers, OXT levels may decrease during the first days following childbirth rather than increase as is the norm. Therefore, the investigators will test the therapeutic effects of OXT in women at risk for PPD. It is hypothesized that administration of IN-OXT (total daily dose 48 IU) over the course of four days from as early as day one postpartum in comparison to placebo will 1) enhance mother-infant bonding, 2) reduce depressive and anxiety symptoms at 5 days postpartum, and 3) facilitate child development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
56
Massachusetts General Hosptial
Boston, Massachusetts, United States
Treatment Effect on Mother-infant Bonding
Day 5 postpartum: Self-report assessment of maternal bonding (Maternal Attachment Inventory, higher scores means better outcome, range 26 -104) 2 months postpartum: Quantitative observational assessment of mother-infant bonding (Coding Interactive Behavior; mean score represents mean score of the study sample. Negative bonding includes age-appropriate items on maternal intrusiveness, infant withdrawal, and dyad negative sub-scales, higher scores indicate higher levels of negative bonding behavior (deviation above the mean represent worse outcome); positive bonding includes maternal sensitivity, maternal limit setting, infant involvement, and dyad reciprocity sub-scales, higher scores indicate higher levels of bonding behavior, deviation above the mean represent better outcome); and repeat of self-report (MAI)
Time frame: 5 days and 2 months postpartum (on average)
Treatment Effect on Maternal Depression Symptoms
Self-reported assessment of severity of maternal depression symptoms (Edinburgh Postnatal Depression Scale, higher scores mean worse outcome, range 0 - 30).
Time frame: Baseline and 5 days postpartum
Treatment Effect on Maternal Anxiety Symptoms
Self-reported severity of maternal anxiety symptoms (Brief Symptom Inventory, Anxiety sub-scale, higher scores means worse outcome, range 0 - 24).
Time frame: Baseline and 5 days postpartum
Child Development
Quantitative observational assessment of infant communication, cognitive, and motor development (Bayley Scales of Infant Development, screening, higher scores better outcome, ranges for each subscale are reported for infants 1-6 months old (items are scored either 0 or 1) - communication scale range 0-4, cognitive scale range 0-7, motor scale range 0-12; note: Bayley Scales can be performed for up to 42 months old infants; developmentally advanced infants may achieve scores above the reported range scale above)
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Time frame: 2 months postpartum (on average)