Mother to Child TransmissionNCT07195058
Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study
A study testing Trauma Informed Obstetric Care (TIOC) in people with Mother to Child Transmission and Breast Feeding, run by Columbia University at 1 site in Argentina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother to Child Transmission, Breast Feeding, Trauma
- What is being tested?
- Trauma Informed Obstetric Care (TIOC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 23 May 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who are <19 weeks pregnant
- Nulliparous (no previous live births)
- 18 or more years of age
- Carrying a single fetus
- Can speak Spanish
Who cannot join
- Any current psychiatric diagnosis or treatment
- Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Materno Infantil Ramon Sardá
Buenos Aires, Buenos Aires F.D., C1246ABQ
Sergio Casini
About this study
Official title: Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical 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.
Read the detailed description
Infants of women who have experienced trauma have up to five times the risk of health and developmental problems. Low-income women are more likely to experience trauma, a factor in the intergenerational transmission of racial and socioeconomic inequities in health and development. In women with trauma histories, pregnancy and the period after the baby is born can be particularly stressful. A new way of improving pregnancy and early childhood outcomes in women with trauma histories is to train obstetric clinicians in the delivery of obstetric care attuned to the unique needs of women with histories of childhood abuse. Models of trauma-informed obstetric and gynecological care (TIOC) have been developed, however, none of these TIOC models have been formally tested for effectiveness. This study aims to develop and test a model of TIOC in a public hospital in Argentina that serves women who experience a high degree of disadvantage.
- Conditions
- Mother to Child Transmission, Breast Feeding, Trauma
- Being tested
- Trauma Informed Obstetric Care (TIOC)
- Keywords
- Adverse childhood experiences (ACE), Edinburgh Postnatal Depression Scale (EPDS), Perceived Stress Scale (PSS), Maternal antenatal attachment scale (MAAS), Social Support Questionnaire (SSQ), Prenatal Distress Questionnaire (NuPDQ), Iowa Infant Feeding scale (IIFAS), Trauma Informed Care
- Medical subject headings
- Breast Feeding, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Informed Obstetric Care (TIOC)Behavioural
TIOC 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:
- Effects of trauma on physiological and psychological process relevant to pregnancy and childbirth.
- Body language and verbal language for safety, respect, and patient agency
- Recognizing and responding to distress and dissociation
| Study group | Role | What they receive |
|---|---|---|
| Trauma Informed Obstetric Care (TIOC) | Experimental | Women randomized to the trauma informed obstetric care (TIOC) intervention will be scheduled for all their prenatal appointments with obstetricians trained in the TIOC model. Additionally, the midwife on duty in the delivery ward will ensure that all items on a checklist of trauma-sensitive birth practices are followed during that participant's labor and delivery Receives: Behavioral: Trauma Informed Obstetric Care (TIOC) |
| Treatment as usual (TAU) | No intervention | Participants randomized to TAU will receive usual prenatal care, which includes a referral to psychological services when deemed necessary by the prenatal care provider. These participants' prenatal visits will not be scheduled with providers who have received TIOC training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-22 weeks gestation, 28-35 weeks gestation
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.
Measured: 8-22 weeks gestation, 28- 35 weeks gestation
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.
Measured: 8-22 weeks gestation, 28-35 weeks gestation
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.
Measured: 8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birth
Prenatal Distress Questionnaire (PDQ) Score
Pregnancy-specific distress will be measured by the PDQ. Scores range from a minimum of 0 to a maximum of 34. The total score reflects the level of prenatal distress, with higher scores indicating higher levels of prenatal stress.
Measured: 8-22 weeks gestation, and 28-35 weeks gestation
Secondary outcomes (4)
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.
Measured: 0-48 hours after birth
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.
Measured: 0-48 hours after birth
Gestational Age at Birth
Infant's gestational age at birth.
Measured: 0-48 hours after birth
Birthweight
Infant's weight at birth.
Measured: 0-48 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start23 May 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother to Child TransmissionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomized to intervention (care with clinicians trained in the TIOC model) or control (treatment as usual). Both groups will receive all study evaluations in parallel.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Materno Infantil Ramón Sardá
- Responsible party
- Principal investigator, Pamela Scorza, Columbia University
- Investigators
- Pamela Scorza, ScD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195058
- Sponsor's protocol ID
- AAAU8914
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07195058
- Acronym / sponsor ID
- AAAU8914
- Conditions
- Mother to Child Transmission, Breast Feeding, Trauma
- Keywords
- Adverse childhood experiences (ACE), Edinburgh Postnatal Depression Scale (EPDS), Perceived Stress Scale (PSS), Maternal antenatal attachment scale (MAAS), Social Support Questionnaire (SSQ), Prenatal Distress Questionnaire (NuPDQ), Iowa Infant Feeding scale (IIFAS), Trauma Informed Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Hospital Materno Infantil Ramón Sardá
- Study start
- 23 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infants of women who have experienced trauma have up to five times the risk of health and developmental problems. Low-income women are more likely to experience trauma, a factor in the intergenerational transmission of racial and socioeconomic inequities in health and development. In women with trauma histories, pregnancy and the period after the baby is born can be particularly stressful. A new way of improving pregnancy and early childhood outcomes in women with trauma histories is to train obstetric clinicians in the delivery of obstetric care attuned to the unique needs of women with histories of childhood abuse. Models of trauma-informed obstetric and gynecological care (TIOC) have been developed, however, none of these TIOC models have been formally tested for effectiveness. This study aims to develop and test a model of TIOC in a public hospital in Argentina that serves women who experience a high degree of disadvantage.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women will be randomized to intervention (care with clinicians trained in the TIOC model) or control (treatment as usual). Both groups will receive all study evaluations in parallel.
| Arm | Type | Receives |
|---|---|---|
| Trauma Informed Obstetric Care (TIOC) | Experimental | Behavioral: Trauma Informed Obstetric Care (TIOC)Women randomized to the trauma informed obstetric care (TIOC) intervention will be scheduled for all their prenatal appointments with obstetricians trained in the TIOC model. Additionally, the midwife on duty in the delivery ward will ensure that all items on a checklist of trauma-sensitive birth practices are followed during that participant's labor and delivery |
| Treatment as usual (TAU) | No intervention | –Participants randomized to TAU will receive usual prenatal care, which includes a referral to psychological services when deemed necessary by the prenatal care provider. These participants' prenatal visits will not be scheduled with providers who have received TIOC training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women who are <19 weeks pregnant
- Nulliparous (no previous live births)
- 18 or more years of age
- Carrying a single fetus
- Can speak Spanish
Key exclusion criteria (2 listed)
- Any current psychiatric diagnosis or treatment
- Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Informed Obstetric Care (TIOC)TIOC 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 | Behavioural | Trauma Informed Obstetric Care (TIOC) |
Primary outcome
Edinburgh Postnatal Depression Scale (EPDS) Score
Time frame: 8-22 weeks gestation, 28-35 weeks gestation
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.
Perceived Stress Scale (PSS) Score
Time frame: 8-22 weeks gestation, 28- 35 weeks gestation
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.
Maternal Antenatal Attachment Scale (MAAS) Score
Time frame: 8-22 weeks gestation, 28-35 weeks gestation
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.
CARE Scale Score
Time frame: 8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birth
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.
Prenatal Distress Questionnaire (PDQ) Score
Time frame: 8-22 weeks gestation, and 28-35 weeks gestation
Pregnancy-specific distress will be measured by the PDQ. Scores range from a minimum of 0 to a maximum of 34. The total score reflects the level of prenatal distress, with higher scores indicating higher levels of prenatal stress.
4 secondary outcomes
Childbirth Experiences Questionnaire Score
Time frame: 0-48 hours after birth
Iowa Infant Feeding Attitudes Scale Score
Time frame: 0-48 hours after birth
Gestational Age at Birth
Time frame: 0-48 hours after birth
Birthweight
Time frame: 0-48 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Scorza, ScD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Informed Obstetric Care (TIOC) in people with Mother to Child Transmission and Breast Feeding, run by Columbia University at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Scorza, ScD (646-246-1092, pls2122@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale (EPDS) Score (time frame: 8-22 weeks gestation, 28-35 weeks gestation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.