The OptiMUM-study: EMDR therapy in pregnant women with posttraumatic stress disorder after previous childbirth and pregnant women with fear of childbirth: design of a multicentre randomized controlled trial

Background: Approximately 3% of women develop posttraumatic stress disorder (PTSD) after giving birth, and 7.5% of pregnant women show a pathological fear of childbirth (FoC). FoC or childbirth-related PTSD during (a subsequent) pregnancy can lead to a request for an elective caesarean section as well as adverse obstetrical and neonatal outcomes. For PTSD in general, and several subtypes of specific phobia, eye movement desensitization and reprocessing (EMDR) therapy has been proven effective, but little is known about the effects of applying EMDR during pregnancy. Objective: To describe the protocol of the OptiMUM-study. The main aim of the study is to determine whether EMDR therapy is an effective and safe treatment for pregnant women with childbirth-related PTSD or FoC. In addition, the cost-effectiveness of this approach will be analysed. Method: The single-blind OptiMUM-study consists of two two-armed randomized controlled trials (RCTs) with overlapping design. In several hospitals and community midwifery practices in Amsterdam, the Netherlands, all eligible pregnant women with a gestational age between eight and 20 weeks will be administered the Wijma delivery expectations questionnaire (WDEQ) to asses FoC. Multiparous women will also receive the PTSD checklist for DSM-5 (PCL-5) to screen for possible PTSD. The clinician administered PTSD scale (CAPS-5) will be used for assessing PTSD according to DSM-5 in women scoring above the PCL-5 cut-off value. Fifty women with childbirth-related PTSD and 120 women with FoC will be randomly allocated to either EMDR therapy carried out by a psychologist or care-as-usual. Women currently undergoing psychological treatment or women younger than 18 years will not be included. Primary outcome measures are severity of childbirth-related PTSD or FoC symptoms. Secondary outcomes are percentage of PTSD diagnoses, percentage caesarean sections, subjective childbirth experience, obstetrical and neonatal complications, and health care costs. Results: The results are meant to provide more insight about the safety and possible effectiveness of EMDR therapy during pregnancy for women with PTSD or FoC. Conclusion: This study is the first RCT studying efficacy and safety of EMDR in pregnant women with PTSD after childbirth or Fear of Childbirth.