Anxiety
Conditions
Keywords
randomized controlled trial, inflammation, hormones
Brief summary
As a supplement to the ongoing randomized evaluation of the Cognitive Behavioral Therapy (CBT) anxiety prevention intervention in Pakistan (R01-MH111859), the investigators propose to explore potential biological mechanisms (related to inflammation and endocrine functioning) of antenatal anxiety through additional data collection with 300 pregnant women.
Detailed description
This study will leverage the ongoing randomized evaluation of the CBT anxiety prevention intervention in Pakistan (R01-MH111859) to explore potential biological mechanisms. This CBT intervention targets both sub-threshold anxiety symptoms and generalized anxiety disorder (GAD) in early- to mid- pregnancy, aiming to both prevent and treat Common Mental Disorders (CMDs) (GAD and major depressive episodes (MDE)) as well as improve birth outcomes. The study team proposes to additionally study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), the study will also include 100 healthy women without anxiety or depression. The aims are to 1) characterize the immune phenotype of anxious women across the peripartum, specifically by measuring the relation among anxiety symptoms and peripheral markers of inflammation within and across women (both anxious and healthy) and between those receiving the intervention and control; 2) determine the relation between levels of allopregnanolone (ALLO) in pregnancy and concurrent anxiety symptoms and future symptoms of postpartum depression (PPD), 3) examine the relation between changes in immune functioning and ALLO levels in anxious pregnancy across time, 4) examine whether immune function and/or ALLO are mediators or moderators of the association between antenatal anxiety and preterm birth and/or small-for-gestational age, and 5) examine the effects of both anxiety and the intervention (including biomarkers) on infant development at six weeks postpartum.
Interventions
BEHAVIORALCognitive Behavioral Therapy (CBT) for anxiety during pregnancy
Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety.
Sponsors
Human Development Research Foundation, Pakistan
Rawalpindi Medical College, Pakistan
University of Liverpool
National Institute of Mental Health (NIMH)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principal investigators and outcomes assessors will be blind to the randomization status of the 200 anxious women assigned to the intervention and enhanced usual care groups.
Intervention model description
Within women in a larger randomized trial (randomized to the intervention or enhanced care group), we propose to study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), we will also include 100 healthy women without anxiety or depression. These enrollment goals were modified after interruptions by the Covid-19 pandemic.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ability to understand spoken Urdu * pregnant, ≤22 weeks' gestation * age ≥18 years * residence ≤20 km of Holy Family Hospital * intent to reside in the study areas until the completion of the study
Exclusion criteria
* Current anemia * Current major depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation * Self-report of past or current significant learning disability * Self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug) * medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101) * ICU admission indicated by diagnosis (not only for assessment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Markers of Inflammation | trimester 1, trimester 2, trimester 3, 6 weeks postpartum | Differences in levels of peripheral inflammatory markers and change in these markers across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious and healthy women, and between intervention and control women. Markers include IFNgamma, IL6, IL8, IL10, IL12p70, TNFalpha, IL17A, TARC, MIP1alpha, MCP4, Eotaxin |
| Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | trimester 2, trimester 3, 6 weeks postpartum | Measure differences in level of allopregnanolone (mean) at each time point and across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious women and healthy women, and between intervention and control. The results are measured by log-transformed values of the concentration of each cytokine in the plasma, in ng/mL (nanogram per milliliter). |
| Allopregnanolone Levels Predicting Postpartum Depression | Trimester 2 | Differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression (PPD). The results are measured by log-transformed values of the concentration of allopregnanolone in the plasma, in ng/ml (nanogram per milliliter. Women who have Allopregnanolone (ALLO) levels and developed PPD are analyzed. |
| Allopregnanolone (ALLO) and Immune Function | trimester 2, trimester 3, 6 weeks postpartum | Measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time (trimester 2 (T2), trimester 3 (T3) and 6 weeks postpartum (W6)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth Outcomes | at birth | Differences in birth outcomes (preterm birth, small for gestational age, low birth weight) between women with high inflammatory markers vs. those low in inflammatory markers, and also between anxious and healthy women. |
| Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | 6 weeks postpartum | Measure infant neuro-development using Ages & Stages Questionnaire to measure differences in infant neurodevelopment (communication, gross motor, fine motor, personal-social and problem solving) using a standardized questionnaire between those high in inflammatory markers vs. those low, and also between anxious and healthy women communication cut-off score 22.77 gross motor cut-off score 41.84 fine motor cut-off score 30.16 personal-social cut-off score 24.62 problem solving cut-off score 33.71 Number of participants with impaired neuron-developmental infants (below cut-off scores) are reported below |
Countries
Pakistan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anxious Pregnant Women - Intervention Group 100 pregnant women who have at least mild anxiety will be randomized to the intervention group where they will receive six one-on-one core sessions of Cognitive Behavioral Therapy during pregnancy (plus possible booster sessions)
Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy: Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety. | 26 |
| Anxious Pregnant Women - Enhanced Usual Care Group 100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits. | 31 |
| Non-anxious Pregnant Women - Healthy Control 100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. They will not receive intervention sessions but will receive transportation vouchers to come to the hospital and facilitation by study staff to attend to their regular antenatal care visits. | 60 |
| Total | 117 |
Baseline characteristics
| Characteristic | Anxious Pregnant Women - Intervention Group | Anxious Pregnant Women - Enhanced Usual Care Group | Non-anxious Pregnant Women - Healthy Control | Total |
|---|---|---|---|---|
| Age, Continuous | 25.65 Years | 24.74 Years | 26.27 Years | 25.73 Years |
| Baseline Hospital Anxiety&Depression Score (HADS) of >=8 on the anxiety subscale for anxious group | 26 participants | 31 participants | 0 participants | 57 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 31 Participants | 60 Participants | 117 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Pakistan | 26 Participants | 31 Participants | 60 Participants | 117 Participants |
| Sex: Female, Male Female | 26 Participants | 31 Participants | 60 Participants | 117 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 31 | 0 / 60 |
| other Total, other adverse events | 0 / 26 | 0 / 31 | 0 / 60 |
| serious Total, serious adverse events | 9 / 26 | 14 / 31 | 20 / 60 |
Outcome results
Primary
Allopregnanolone (ALLO) and Immune Function
Measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time (trimester 2 (T2), trimester 3 (T3) and 6 weeks postpartum (W6))
Time frame: trimester 2, trimester 3, 6 weeks postpartum
Population: Trimester 2, 3, postpartum
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL8 | 0.965403419 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_TARC | 0.12961388 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_TNFalp | 0.620118634 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL10 | 0.442764509 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_MIP1alp | 0.40714722 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_EOTAXIN | 0.438406999 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_TARC | 0.065203743 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL8 | 0.681722947 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IFNgam | 0.404728602 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL6 | 0.653576209 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL6 | 0.663796915 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL10 | 0.119629591 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL12P70 | 0.043026211 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL17A | 0.771455608 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL12P70 | 0.933378078 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_EOTAXIN | 0.607838873 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL17A | 0.803123246 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL17A | 0.994071069 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_TNFalp | 0.286463458 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL12P70 | 0.434897804 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL6 | 0.661240061 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_MCP4 | 0.752085053 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL10 | 0.380554726 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL8 | 0.58507263 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_MCP4 | 0.725048008 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IFNgam | 0.778831242 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_MCP4 | 0.253876939 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IFNgam | 0.943495625 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_EOTAXIN | 0.056363143 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_MIP1alp | 0.211464436 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_MIP1alp | 0.134643876 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_TNFalp | 0.25342432 p value |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_TARC | 0.044208627 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL8 | 0.377422318 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_MCP4 | 0.420134106 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_EOTAXIN | 0.508436643 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IFNgam | 0.962951805 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL10 | 0.852343415 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL12P70 | 0.182583506 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL17A | 0.628278059 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL6 | 0.433900134 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_MCP4 | 0.975614712 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_MIP1alp | 0.219395666 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_TARC | 0.09877797 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_TNFalp | 0.452187217 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_EOTAXIN | 0.484822182 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IFNgam | 0.373945489 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL10 | 0.335957072 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL12P70 | 0.337344443 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL17A | 0.280587079 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL6 | 0.083926433 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL8 | 0.570578156 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_MIP1alp | 0.241913557 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_TARC | 0.420828347 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_TNFalp | 0.921598373 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_EOTAXIN | 0.488055787 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IFNgam | 0.493655855 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL10 | 0.706511155 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL12P70 | 0.707672478 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL17A | 0.514072112 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL6 | 0.999655946 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL8 | 0.224965514 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_MCP4 | 0.54436977 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_MIP1alp | 0.277197163 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_TARC | 0.923420368 p value |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_TNFalp | 0.694997299 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_TNFalp | 0.965333979 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_TNFalp | 0.981377152 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_MCP4 | 0.261553 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL8 | 0.183430195 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_EOTAXIN | 0.00049734 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL8 | 0.000902406 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_EOTAXIN | 0.731221724 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IFNgam | 0.019717559 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL6 | 0.101928485 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_TARC | 0.922589566 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL10 | 0.038619177 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL17A | 0.155033717 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_MCP4 | 0.42633973 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL12P70 | 0.086203475 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL12P70 | 0.032112919 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_MIP1alp | 0.571967334 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL12P70 | 0.898094409 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL10 | 0.299247829 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL17A | 0.132466231 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL17A | 0.412507598 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IFNgam | 0.747287036 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IL10 | 0.251810201 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL6 | 0.526805187 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_EOTAXIN | 0.644129208 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_MCP4 | 0.090351732 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_IL8 | 0.447858 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_TNFalp | 0.389716682 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | W6 Allo and W6_IL6 | 0.174873815 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_MIP1alp | 0.454254606 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_TARC | 0.482216914 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_IFNgam | 0.32767424 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T3 Allo and T3_TARC | 0.604242922 p value |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone (ALLO) and Immune Function | T2 Allo and T2_MIP1alp | 0.757648777 p value |
Primary
Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
Measure differences in level of allopregnanolone (mean) at each time point and across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious women and healthy women, and between intervention and control. The results are measured by log-transformed values of the concentration of each cytokine in the plasma, in ng/mL (nanogram per milliliter).
Time frame: trimester 2, trimester 3, 6 weeks postpartum
Population: trimester 2, trimester 3, 6 weeks postpartum
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxious Pregnant Women - Intervention Group | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at T3 | 2.825177 log (ng/ml) | Standard Deviation 0.995552 |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at T2 | -0.3796214 log (ng/ml) | Standard Deviation 0.7621596 |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at W6 | -0.592519 log (ng/ml) | Standard Deviation 0.5954829 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at T3 | 3.149545 log (ng/ml) | Standard Deviation 0.3715666 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at T2 | -0.3828328 log (ng/ml) | Standard Deviation 0.8335611 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at W6 | -0.6423627 log (ng/ml) | Standard Deviation 0.5764104 |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at T2 | -0.2820709 log (ng/ml) | Standard Deviation 0.9410302 |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at W6 | -0.7948805 log (ng/ml) | Standard Deviation 0.4380674 |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum | Allopregnanolone at T3 | 3.048794 log (ng/ml) | Standard Deviation 0.3715666 |
Primary
Allopregnanolone Levels Predicting Postpartum Depression
Differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression (PPD). The results are measured by log-transformed values of the concentration of allopregnanolone in the plasma, in ng/ml (nanogram per milliliter. Women who have Allopregnanolone (ALLO) levels and developed PPD are analyzed.
Time frame: Trimester 2
Population: Trimester 2. The numbers of analyzed data is lower than the overall number since not every women who had ALLO had also data available for PPD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxious Pregnant Women - Intervention Group | Allopregnanolone Levels Predicting Postpartum Depression | Allopregnanolone at T2 in women with PPD | -0.004127186 log (ng/ml) | Standard Deviation 0.7631303 |
| Anxious Pregnant Women - Intervention Group | Allopregnanolone Levels Predicting Postpartum Depression | Allopregnanolone at T2 in women without PPD | -0.4591347 log (ng/ml) | Standard Deviation 0.7616261 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone Levels Predicting Postpartum Depression | Allopregnanolone at T2 in women with PPD | -0.8292861 log (ng/ml) | Standard Deviation 0.7694288 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Allopregnanolone Levels Predicting Postpartum Depression | Allopregnanolone at T2 in women without PPD | -0.08843005 log (ng/ml) | Standard Deviation 0.7569726 |
| Non-anxious Pregnant Women - Healthy Control | Allopregnanolone Levels Predicting Postpartum Depression | Allopregnanolone at T2 in women without PPD | -0.1739193 log (ng/ml) | Standard Deviation 0.9115309 |
Primary
Peripheral Markers of Inflammation
Differences in levels of peripheral inflammatory markers and change in these markers across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious and healthy women, and between intervention and control women. Markers include IFNgamma, IL6, IL8, IL10, IL12p70, TNFalpha, IL17A, TARC, MIP1alpha, MCP4, Eotaxin
Time frame: trimester 1, trimester 2, trimester 3, 6 weeks postpartum
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL8 at T2 | 1.69 pg/ml | Standard Deviation 0.67 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | Eotaxin at T3 | 58.00 pg/ml | Standard Deviation 23.23 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MIP1alpha at T1 | 2.52 pg/ml | Standard Deviation 1.61 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL8 at T1 | 1.94 pg/ml | Standard Deviation 0.62 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | Eotaxin at PP | 222.59 pg/ml | Standard Deviation 91.64 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TNFalpha at T3 | 0.94 pg/ml | Standard Deviation 0.23 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL6 at T3 | 0.63 pg/ml | Standard Deviation 0.27 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL17A at T1 | 1.01 pg/ml | Standard Deviation 1.26 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL12P70 at T3 | 0.05 pg/ml | Standard Deviation 0.03 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL6 at T2 | 0.44 pg/ml | Standard Deviation 0.19 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL17A at T2 | 1.15 pg/ml | Standard Deviation 1.67 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MIP1alpha at T2 | 4.09 pg/ml | Standard Deviation 4.33 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL6 at T1 | 0.38 pg/ml | Standard Deviation 0.13 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL17A at T3 | 1.19 pg/ml | Standard Deviation 1.29 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TARC at T2 | 11.78 pg/ml | Standard Deviation 8.3 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IFN gamma at PP | 14.64 pg/ml | Standard Deviation 21.57 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL17A at PP | 2.08 pg/ml | Standard Deviation 2.29 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL12P70 at T2 | 0.04 pg/ml | Standard Deviation 0.03 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IFN gamma at T3 | 4.67 pg/ml | Standard Deviation 3.61 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IFN gamma at T1 | 8.85 pg/ml | Standard Deviation 15.44 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MIP1alpha at T3 | 2.45 pg/ml | Standard Deviation 0.99 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IFN gamma at T2 | 6.09 pg/ml | Standard Deviation 4.07 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL6 at PP | 0.58 pg/ml | Standard Deviation 0.21 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL12P70 at T1 | 0.04 pg/ml | Standard Deviation 0.03 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MIP1alpha at PP | 3.62 pg/ml | Standard Deviation 0.83 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TNFalpha at T2 | 0.74 pg/ml | Standard Deviation 0.13 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL10 at PP | 0.30 pg/ml | Standard Deviation 0.35 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MCP4 at T1 | 45.70 pg/ml | Standard Deviation 28.3 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TARC at T3 | 6.06 pg/ml | Standard Deviation 2.95 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL10 at T3 | 0.26 pg/ml | Standard Deviation 0.2 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MCP4 at T2 | 35.46 pg/ml | Standard Deviation 24.07 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TARC at T1 | 17.09 pg/ml | Standard Deviation 10.3 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL10 at T2 | 0.16 pg/ml | Standard Deviation 0.06 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MCP4 at T3 | 25.89 pg/ml | Standard Deviation 13.96 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TNFalpha at T1 | 0.69 pg/ml | Standard Deviation 0.14 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL10 at T1 | 0.17 pg/ml | Standard Deviation 0.1 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | MCP4 at PP | 72.87 pg/ml | Standard Deviation 27.65 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TARC at PP | 15.28 pg/ml | Standard Deviation 6.4 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL8 at PP | 3.28 pg/ml | Standard Deviation 1.4 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | Eotaxin at T1 | 157.87 pg/ml | Standard Deviation 65.2 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | TNFalpha at PP | 1.29 pg/ml | Standard Deviation 0.44 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL8 at T3 | 2.09 pg/ml | Standard Deviation 1.22 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | Eotaxin at T2 | 112.06 pg/ml | Standard Deviation 46.94 |
| Anxious Pregnant Women - Intervention Group | Peripheral Markers of Inflammation | IL12P70 at PP | 0.05 pg/ml | Standard Deviation 0.05 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL12P70 at T3 | 0.04 pg/ml | Standard Deviation 0.04 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TARC at T1 | 20.22 pg/ml | Standard Deviation 10.85 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TARC at T2 | 12.12 pg/ml | Standard Deviation 7.18 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TARC at T3 | 7.52 pg/ml | Standard Deviation 3.29 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TARC at PP | 18.07 pg/ml | Standard Deviation 8.84 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MIP1alpha at T1 | 2.17 pg/ml | Standard Deviation 0.75 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MIP1alpha at T2 | 2.93 pg/ml | Standard Deviation 1.45 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MIP1alpha at T3 | 2.22 pg/ml | Standard Deviation 0.6 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MIP1alpha at PP | 3.23 pg/ml | Standard Deviation 0.83 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MCP4 at T1 | 57.08 pg/ml | Standard Deviation 33.28 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MCP4 at T2 | 41.26 pg/ml | Standard Deviation 20.78 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MCP4 at T3 | 30.10 pg/ml | Standard Deviation 14.83 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | MCP4 at PP | 67.84 pg/ml | Standard Deviation 25.82 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | Eotaxin at T1 | 178.82 pg/ml | Standard Deviation 75.27 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | Eotaxin at T2 | 141.96 pg/ml | Standard Deviation 70.1 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | Eotaxin at T3 | 72.12 pg/ml | Standard Deviation 25.54 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | Eotaxin at PP | 187.66 pg/ml | Standard Deviation 78.5 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL17A at T1 | 1.28 pg/ml | Standard Deviation 1.44 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL17A at T2 | 0.90 pg/ml | Standard Deviation 0.85 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL17A at T3 | 1.12 pg/ml | Standard Deviation 7.98 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL17A at PP | 1.56 pg/ml | Standard Deviation 0.85 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IFN gamma at T1 | 6.77 pg/ml | Standard Deviation 7.98 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IFN gamma at T2 | 7.57 pg/ml | Standard Deviation 9.55 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IFN gamma at T3 | 4.44 pg/ml | Standard Deviation 2.34 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IFN gamma at PP | 10.50 pg/ml | Standard Deviation 9.13 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL6 at T1 | 0.39 pg/ml | Standard Deviation 0.22 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL6 at T2 | 0.44 pg/ml | Standard Deviation 0.4 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL6 at PP | 0.59 pg/ml | Standard Deviation 0.37 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL8 at T1 | 2.09 pg/ml | Standard Deviation 1.04 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL8 at T2 | 2.12 pg/ml | Standard Deviation 1.27 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL8 at T3 | 2.32 pg/ml | Standard Deviation 0.91 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL8 at PP | 3.45 pg/ml | Standard Deviation 0.92 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL10 at T1 | 0.23 pg/ml | Standard Deviation 0.36 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL10 at T2 | 0.21 pg/ml | Standard Deviation 0.14 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL10 at T3 | 0.19 pg/ml | Standard Deviation 0.09 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL10 at PP | 0.22 pg/ml | Standard Deviation 0.15 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL12P70 at T1 | 0.05 pg/ml | Standard Deviation 0.03 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL12P70 at T2 | 0.05 pg/ml | Standard Deviation 0.04 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL6 at T3 | 0.55 pg/ml | Standard Deviation 0.32 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | IL12P70 at PP | 0.04 pg/ml | Standard Deviation 0.06 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TNFalpha at T1 | 0.65 pg/ml | Standard Deviation 0.14 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TNFalpha at T2 | 0.75 pg/ml | Standard Deviation 0.25 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TNFalpha at T3 | 0.86 pg/ml | Standard Deviation 0.22 |
| Anxious Pregnant Women - Enhanced Usual Care Group | Peripheral Markers of Inflammation | TNFalpha at PP | 1.11 pg/ml | Standard Deviation 0.26 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TARC at PP | 16.81 pg/ml | Standard Deviation 11.03 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL8 at T2 | 1.91 pg/ml | Standard Deviation 0.81 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | Eotaxin at T1 | 140.11 pg/ml | Standard Deviation 66.73 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TNFalpha at PP | 1.12 pg/ml | Standard Deviation 0.27 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL8 at T3 | 2.03 pg/ml | Standard Deviation 0.81 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MCP4 at PP | 65.53 pg/ml | Standard Deviation 29.78 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL12P70 at PP | 0.06 pg/ml | Standard Deviation 0.09 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL8 at PP | 3.33 pg/ml | Standard Deviation 1.68 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MCP4 at T3 | 22.86 pg/ml | Standard Deviation 8.61 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TARC at T3 | 6.65 pg/ml | Standard Deviation 3.35 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL10 at T1 | 0.20 pg/ml | Standard Deviation 0.13 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MCP4 at T2 | 33.27 pg/ml | Standard Deviation 16.69 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TNFalpha at T3 | 0.98 pg/ml | Standard Deviation 0.33 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL10 at T2 | 0.26 pg/ml | Standard Deviation 0.36 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MCP4 at T1 | 42.32 pg/ml | Standard Deviation 20.64 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TNFalpha at T1 | 0.65 pg/ml | Standard Deviation 0.16 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL10 at T3 | 0.25 pg/ml | Standard Deviation 0.31 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MIP1alpha at PP | 3.54 pg/ml | Standard Deviation 0.99 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TARC at T2 | 11.65 pg/ml | Standard Deviation 7.87 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL10 at PP | 0.21 pg/ml | Standard Deviation 0.2 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MIP1alpha at T3 | 2.28 pg/ml | Standard Deviation 1.02 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL6 at T3 | 0.64 pg/ml | Standard Deviation 0.48 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IFN gamma at T1 | 5.27 pg/ml | Standard Deviation 3.49 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL12P70 at T1 | 0.51 pg/ml | Standard Deviation 0.03 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IFN gamma at T2 | 6.07 pg/ml | Standard Deviation 3.98 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL17A at PP | 2.64 pg/ml | Standard Deviation 4.67 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MIP1alpha at T2 | 3.41 pg/ml | Standard Deviation 1.43 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IFN gamma at T3 | 4.53 pg/ml | Standard Deviation 3.35 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL17A at T3 | 1.26 pg/ml | Standard Deviation 3.05 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TNFalpha at T2 | 0.81 pg/ml | Standard Deviation 0.21 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IFN gamma at PP | 8.27 pg/ml | Standard Deviation 9.5 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL17A at T2 | 0.81 pg/ml | Standard Deviation 0.55 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL12P70 at T2 | 0.07 pg/ml | Standard Deviation 0.04 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL6 at T1 | 0.42 pg/ml | Standard Deviation 0.19 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL17A at T1 | 1.06 pg/ml | Standard Deviation 1.14 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | MIP1alpha at T1 | 2.16 pg/ml | Standard Deviation 0.74 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL6 at T2 | 0.48 pg/ml | Standard Deviation 0.24 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | Eotaxin at PP | 182.52 pg/ml | Standard Deviation 73.72 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | TARC at T1 | 14.79 pg/ml | Standard Deviation 8.06 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL6 at PP | 0.66 pg/ml | Standard Deviation 0.36 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | Eotaxin at T3 | 55.80 pg/ml | Standard Deviation 24.26 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL12P70 at T3 | 0.05 pg/ml | Standard Deviation 0.03 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | IL8 at T1 | 1.89 pg/ml | Standard Deviation 0.72 |
| Non-anxious Pregnant Women - Healthy Control | Peripheral Markers of Inflammation | Eotaxin at T2 | 101.17 pg/ml | Standard Deviation 39.15 |
Secondary
Birth Outcomes
Differences in birth outcomes (preterm birth, small for gestational age, low birth weight) between women with high inflammatory markers vs. those low in inflammatory markers, and also between anxious and healthy women.
Time frame: at birth
Population: The number analyzed is different than the overall number because data was not collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anxious Pregnant Women - Intervention Group | Birth Outcomes | small for gestational age | 5 Participants |
| Anxious Pregnant Women - Intervention Group | Birth Outcomes | preterm birth | 5 Participants |
| Anxious Pregnant Women - Intervention Group | Birth Outcomes | low birth weight | 11 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Birth Outcomes | small for gestational age | 6 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Birth Outcomes | preterm birth | 3 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Birth Outcomes | low birth weight | 8 Participants |
| Non-anxious Pregnant Women - Healthy Control | Birth Outcomes | preterm birth | 3 Participants |
| Non-anxious Pregnant Women - Healthy Control | Birth Outcomes | low birth weight | 13 Participants |
| Non-anxious Pregnant Women - Healthy Control | Birth Outcomes | small for gestational age | 8 Participants |
Secondary
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
Measure infant neuro-development using Ages & Stages Questionnaire to measure differences in infant neurodevelopment (communication, gross motor, fine motor, personal-social and problem solving) using a standardized questionnaire between those high in inflammatory markers vs. those low, and also between anxious and healthy women communication cut-off score 22.77 gross motor cut-off score 41.84 fine motor cut-off score 30.16 personal-social cut-off score 24.62 problem solving cut-off score 33.71 Number of participants with impaired neuron-developmental infants (below cut-off scores) are reported below
Time frame: 6 weeks postpartum
Population: The number analyzed is different than the overall number because data was not collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anxious Pregnant Women - Intervention Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | personal-social below cut-off score | 1 Participants |
| Anxious Pregnant Women - Intervention Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | fine motor below cut-off score | 1 Participants |
| Anxious Pregnant Women - Intervention Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | communication below cut-off score | 0 Participants |
| Anxious Pregnant Women - Intervention Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | gross motor below cut-off score | 3 Participants |
| Anxious Pregnant Women - Intervention Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | problem solving below cut-off score | 1 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | fine motor below cut-off score | 0 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | communication below cut-off score | 0 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | gross motor below cut-off score | 2 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | personal-social below cut-off score | 0 Participants |
| Anxious Pregnant Women - Enhanced Usual Care Group | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | problem solving below cut-off score | 0 Participants |
| Non-anxious Pregnant Women - Healthy Control | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | problem solving below cut-off score | 0 Participants |
| Non-anxious Pregnant Women - Healthy Control | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | personal-social below cut-off score | 0 Participants |
| Non-anxious Pregnant Women - Healthy Control | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | communication below cut-off score | 0 Participants |
| Non-anxious Pregnant Women - Healthy Control | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | fine motor below cut-off score | 0 Participants |
| Non-anxious Pregnant Women - Healthy Control | Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3) | gross motor below cut-off score | 1 Participants |