Utility of early, short psychological care for women who experience early miscarriage: protocol for the randomized, controlled MisTher trial.

BACKGROUND: Around one in ten women will have a miscarriage in their lifetime. Miscarriage is often considered a trivial event by caregivers, but it is associated with a high burden of psychological morbidity, especially during the first 6 months. There is no validated psychological management strategy for women who have had a miscarriage. The MisTher study aims to evaluate the utility of early, short psychological care for women who have had early miscarriage, in terms of anxiety, depression and post-traumatic stress disorder. METHODS: This is a prospective, multicenter, randomized, controlled, superiority study. In total, 932 women who have experienced early miscarriage (spontaneous interruption of pregnancy prior to 14 weeks of gestation) will be randomly assigned to either the intervention or the control group. The intervention consists of 4 teleconsultations of 45 min with a psychologist. All women, regardless of their allocated group, will be encouraged to seek an early consultation with a general practitioner or midwife. The primary endpoint will be anxiety at 3 months after randomization evaluated using State Trait Anxiety Inventory. The secondary endpoints will be anxiety at 6 months evaluated using State Trait Anxiety Inventory, depression at 3 and 6 months evaluated with the Beck Depression Inventory, and post-traumatic stress disorder at 3 and 6 months, evaluated using the Posttraumatic stress disorder Checklist Scale. DISCUSSION: This project will validate the importance of early psychological management, based on primary care and accessible to most women, via teleconsultation, in reducing the frequency of psychological disorders after early miscarriage. Our results should provide a basis for new recommendations for the management of women who have experienced miscarriage, notably by recommending the involvement of trained psychologists in the management pathway for these women. TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov: NCT05653414. December 15th, 2022.

Pregnancy denial and early infant development: a case-control observational prospective study.

BACKGROUND: The denial of pregnancy is the non-recognition of the state of the current pregnancy by a pregnant woman. It lasts for a few months or for the whole pregnancy, with generally few physical transformations. In this study, we will consider the denial of pregnancy as a late declaration of pregnancy (beyond 20 weeks of gestation) as well as a lack of objective perceptions of this pregnancy. The main objective of this study is to explore the relationship between pregnancy denial and the development of the infant (attachment pattern of the infant, early interactions of mother-infant dyads, and early development of the infant). METHODS: The design is a case-control prospective study, which will compare two groups of mother-infant dyads: a "case" group with maternal denials of pregnancy and a "control" group without denials of pregnancy. A total of 140 dyads (mother + infant) will be included in this study (70 cases and 70 controls) and followed for 18 months. The setting is a national recruitment setting with 10 centers distributed all over France. The follow-up of the "cases" and the "controls" will be identical and will occur over 5 visits. It will include measures of the infant attachment pattern, the quality of early mother-infant interaction and infant development. DISCUSSION: This study aims to examine the pathogenesis of pregnancy denial as well as its consequences on early infant development and early mother-infant interaction. TRIAL REGISTRATION: Clinical Trial Number: NCT02867579 on the date of 16 August 2016 (retrospectively registered).