Abstract

Insomnia is common during pregnancy and has been associated with poor maternal and infant outcomes. We evaluated the effect of cognitive behavioral therapy for insomnia (CBTI) during pregnancy on obstetric outcomes, and hypothesized that treatment would result in better obstetric outcomes. This is a pre-planned secondary analysis of obstetric outcomes from a randomized controlled trial (RCT) of CBTI during pregnancy where the primary outcome was the Insomnia Severity Index (ISI). Eligibility for the RCT were a diagnosis of Insomnia Disorder based on Diagnostic and Statistical Manual for Mental Disorders 5th edition criteria, and gestational age of 18-32 weeks at enrollment. Women with comorbid sleep disorders, psychiatric disorders including major depressive disorder, and concomitant treatments that could impact sleep were ineligible. Women were randomized to 5 individual therapy sessions of CBTI or a control treatment. ISI was measured at baseline, weekly during treatment, and monthly post treatment. Obstetric outcomes were extracted from charts and included birthweight, gestational age at delivery, mode of delivery, hypertensive disorders and gestational diabetes, and were compared with ISI scores. 154 women were analyzed. Women whose insomnia remitted (ISI< 8 post-treatment) had a later gestational age at delivery (39.51+1.23 vs. 38.79+2.18 weeks; p=.035); there were no differences in birthweight, operative vaginal delivery, hypertensive disorders or gestational diabetes. Although CBTI resulted in better insomnia outcome (Manber R. et al., Obstet Gynecol 2019), obstetric outcomes were similar between treatment arms (p-values >0.3). Women who underwent cesarean for any reason (29%) had a higher ISI at baseline (15.13+4.23 vs. 17.05+4.55; p=0.019). Lower ISI scores at baseline and insomnia remittance resulted in better obstetric outcomes. Assessment for and treatment of insomnia disorder during pregnancy is important. Future adequately powered studies of CBTI should identify moderators and mediators of its effects on obstetric outcomes.

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