Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorColumbia University
About this trial
The study will test trauma-informed obstetric care training and supervision for obstetric clinicians in relation to prenatal mental health and attachment formation (early predictors of child development) in women presenting for prenatal care in a public hospital in Buenos Aires, Argentina.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women who are <19 weeks pregnant
Nulliparous (no previous live births)
18 or more years of age
Carrying a single fetus
Disqualifiers
Any current psychiatric diagnosis or treatment
Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Trauma Informed Obstetric Care (TIOC)
BehavioralTIOC providers will receive a training that was developed for this study. Elements of trauma-informed care described in the literature -combined with the experience of the study team, with deep expertise in trauma-informed obstetric care, were used to create three training modules, each of which includes didactics and role-plays to help participants practice and embody skills they learn. The three modules are: 1. Effects of trauma on physiological and psychological process relevant to pregnancy and childbirth. 2. Body language and verbal language for safety, respect, and patient agency 3. Recognizing and responding to distress and dissociation
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Trauma Informed Obstetric Care (TIOC)Experimental treatment 1 intervention
Group B: Treatment as usual (TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Edinburgh Postnatal Depression Scale (EPDS) Score
Depression and anxiety symptoms during pregnancy will be measured by the EPDS. The scores range from a minimum of 0 to a maximum of 30. The total score reflects the level of depression, with higher scores indicating higher depression.
Time frame
8-22 weeks gestation, 28-35 weeks gestation2
Perceived Stress Scale (PSS) Score
Perceived stress during pregnancy will be measured by the PSS. Scores range from a minimum of 0 to a maximum 40. The total score reflects the level of stress during pregnancy, with higher scores indicating higher stress.
Time frame
8-22 weeks gestation, 28- 35 weeks gestation3
Maternal Antenatal Attachment Scale (MAAS) Score
Maternal Attachment Feelings toward fetus during pregnancy will be measured by the MAAS. Scores range from a minimum of 19 to a maximum of 95. The total score reflects maternal attachment, with higher scores indicating higher maternal-fetal attachment.
Time frame
8-22 weeks gestation, 28-35 weeks gestation4
CARE Scale Score
The mother's experience of care provided will be measured by the CARE Scale. Scores range from a minimum of 10 to a maximum of 50. The total score reflects the level of perceived empathy, with higher scores indicating higher empathy.
Time frame
8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birthSecondary outcomes
1
Childbirth Experiences Questionnaire Score
The mother's experience of childbirth will be measured with the Childbirth Experiences Questionnaire. The total score ranges from 1 to 4, with 1 indicating positive experiences of childbirth and 4 indicating negative experiences of childbirth.
Time frame
0-48 hours after birth2
Iowa Infant Feeding Attitudes Scale Score
The mother's attitudes and attention towards infant feeding will be measured using the Iowa Infant Feeding Attitudes Scale. Scores range from a minimum of 17 to a maximum 85, with a higher score indicating more positive attitudes toward breastfeeding.
Time frame
0-48 hours after birth3
Gestational Age at Birth
Infant's gestational age at birth.
Time frame
0-48 hours after birth4
Birthweight
Infant's weight at birth.
Time frame
0-48 hours after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Hospital Materno Infantil Ramón Sardá
Collaborator
Source ClinicalTrials.gov