Trial Outcomes & Findings for Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy (NCT NCT04566861)
NCT ID: NCT04566861
Last Updated: 2024-11-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
trimester 1, trimester 2, trimester 3, 6 weeks postpartum
Results posted on
2024-11-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
31
|
60
|
|
Overall Study
COMPLETED
|
17
|
19
|
42
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy
Baseline characteristics by cohort
| Measure |
Anxious Pregnant Women - Intervention Group
n=26 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=31 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=60 Participants
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.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.65 Years
n=5 Participants
|
24.74 Years
n=7 Participants
|
26.27 Years
n=5 Participants
|
25.73 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Pakistan
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Baseline Hospital Anxiety&Depression Score (HADS) of >=8 on the anxiety subscale for anxious group
|
26 participants
n=5 Participants
|
31 participants
n=7 Participants
|
0 participants
n=5 Participants
|
57 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: trimester 1, trimester 2, trimester 3, 6 weeks postpartumDifferences 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
Outcome measures
| Measure |
Anxious Pregnant Women - Intervention Group
n=26 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=31 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=60 Participants
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.
|
|---|---|---|---|
|
Peripheral Markers of Inflammation
Eotaxin at T1
|
157.87 pg/ml
Standard Deviation 65.20
|
178.82 pg/ml
Standard Deviation 75.27
|
140.11 pg/ml
Standard Deviation 66.73
|
|
Peripheral Markers of Inflammation
Eotaxin at T2
|
112.06 pg/ml
Standard Deviation 46.94
|
141.96 pg/ml
Standard Deviation 70.10
|
101.17 pg/ml
Standard Deviation 39.15
|
|
Peripheral Markers of Inflammation
Eotaxin at T3
|
58.00 pg/ml
Standard Deviation 23.23
|
72.12 pg/ml
Standard Deviation 25.54
|
55.80 pg/ml
Standard Deviation 24.26
|
|
Peripheral Markers of Inflammation
IL17A at T2
|
1.15 pg/ml
Standard Deviation 1.67
|
0.90 pg/ml
Standard Deviation 0.85
|
0.81 pg/ml
Standard Deviation 0.55
|
|
Peripheral Markers of Inflammation
IL17A at T3
|
1.19 pg/ml
Standard Deviation 1.29
|
1.12 pg/ml
Standard Deviation 7.98
|
1.26 pg/ml
Standard Deviation 3.05
|
|
Peripheral Markers of Inflammation
IL17A at PP
|
2.08 pg/ml
Standard Deviation 2.29
|
1.56 pg/ml
Standard Deviation 0.85
|
2.64 pg/ml
Standard Deviation 4.67
|
|
Peripheral Markers of Inflammation
IFN gamma at T1
|
8.85 pg/ml
Standard Deviation 15.44
|
6.77 pg/ml
Standard Deviation 7.98
|
5.27 pg/ml
Standard Deviation 3.49
|
|
Peripheral Markers of Inflammation
IFN gamma at PP
|
14.64 pg/ml
Standard Deviation 21.57
|
10.50 pg/ml
Standard Deviation 9.13
|
8.27 pg/ml
Standard Deviation 9.50
|
|
Peripheral Markers of Inflammation
IL6 at T3
|
0.63 pg/ml
Standard Deviation 0.27
|
0.55 pg/ml
Standard Deviation 0.32
|
0.64 pg/ml
Standard Deviation 0.48
|
|
Peripheral Markers of Inflammation
IL6 at PP
|
0.58 pg/ml
Standard Deviation 0.21
|
0.59 pg/ml
Standard Deviation 0.37
|
0.66 pg/ml
Standard Deviation 0.36
|
|
Peripheral Markers of Inflammation
IL8 at T2
|
1.69 pg/ml
Standard Deviation 0.67
|
2.12 pg/ml
Standard Deviation 1.27
|
1.91 pg/ml
Standard Deviation 0.81
|
|
Peripheral Markers of Inflammation
IL8 at T3
|
2.09 pg/ml
Standard Deviation 1.22
|
2.32 pg/ml
Standard Deviation 0.91
|
2.03 pg/ml
Standard Deviation 0.81
|
|
Peripheral Markers of Inflammation
IL10 at T1
|
0.17 pg/ml
Standard Deviation 0.10
|
0.23 pg/ml
Standard Deviation 0.36
|
0.20 pg/ml
Standard Deviation 0.13
|
|
Peripheral Markers of Inflammation
TNFalpha at T2
|
0.74 pg/ml
Standard Deviation 0.13
|
0.75 pg/ml
Standard Deviation 0.25
|
0.81 pg/ml
Standard Deviation 0.21
|
|
Peripheral Markers of Inflammation
TNFalpha at PP
|
1.29 pg/ml
Standard Deviation 0.44
|
1.11 pg/ml
Standard Deviation 0.26
|
1.12 pg/ml
Standard Deviation 0.27
|
|
Peripheral Markers of Inflammation
TNFalpha at T1
|
0.69 pg/ml
Standard Deviation 0.14
|
0.65 pg/ml
Standard Deviation 0.14
|
0.65 pg/ml
Standard Deviation 0.16
|
|
Peripheral Markers of Inflammation
TARC at T1
|
17.09 pg/ml
Standard Deviation 10.30
|
20.22 pg/ml
Standard Deviation 10.85
|
14.79 pg/ml
Standard Deviation 8.06
|
|
Peripheral Markers of Inflammation
TARC at T2
|
11.78 pg/ml
Standard Deviation 8.30
|
12.12 pg/ml
Standard Deviation 7.18
|
11.65 pg/ml
Standard Deviation 7.87
|
|
Peripheral Markers of Inflammation
TARC at T3
|
6.06 pg/ml
Standard Deviation 2.95
|
7.52 pg/ml
Standard Deviation 3.29
|
6.65 pg/ml
Standard Deviation 3.35
|
|
Peripheral Markers of Inflammation
TARC at PP
|
15.28 pg/ml
Standard Deviation 6.40
|
18.07 pg/ml
Standard Deviation 8.84
|
16.81 pg/ml
Standard Deviation 11.03
|
|
Peripheral Markers of Inflammation
MIP1alpha at T1
|
2.52 pg/ml
Standard Deviation 1.61
|
2.17 pg/ml
Standard Deviation 0.75
|
2.16 pg/ml
Standard Deviation 0.74
|
|
Peripheral Markers of Inflammation
MIP1alpha at T2
|
4.09 pg/ml
Standard Deviation 4.33
|
2.93 pg/ml
Standard Deviation 1.45
|
3.41 pg/ml
Standard Deviation 1.43
|
|
Peripheral Markers of Inflammation
MIP1alpha at T3
|
2.45 pg/ml
Standard Deviation 0.99
|
2.22 pg/ml
Standard Deviation 0.60
|
2.28 pg/ml
Standard Deviation 1.02
|
|
Peripheral Markers of Inflammation
MIP1alpha at PP
|
3.62 pg/ml
Standard Deviation 0.83
|
3.23 pg/ml
Standard Deviation 0.83
|
3.54 pg/ml
Standard Deviation 0.99
|
|
Peripheral Markers of Inflammation
MCP4 at T1
|
45.70 pg/ml
Standard Deviation 28.30
|
57.08 pg/ml
Standard Deviation 33.28
|
42.32 pg/ml
Standard Deviation 20.64
|
|
Peripheral Markers of Inflammation
MCP4 at T2
|
35.46 pg/ml
Standard Deviation 24.07
|
41.26 pg/ml
Standard Deviation 20.78
|
33.27 pg/ml
Standard Deviation 16.69
|
|
Peripheral Markers of Inflammation
MCP4 at T3
|
25.89 pg/ml
Standard Deviation 13.96
|
30.10 pg/ml
Standard Deviation 14.83
|
22.86 pg/ml
Standard Deviation 8.61
|
|
Peripheral Markers of Inflammation
MCP4 at PP
|
72.87 pg/ml
Standard Deviation 27.65
|
67.84 pg/ml
Standard Deviation 25.82
|
65.53 pg/ml
Standard Deviation 29.78
|
|
Peripheral Markers of Inflammation
Eotaxin at PP
|
222.59 pg/ml
Standard Deviation 91.64
|
187.66 pg/ml
Standard Deviation 78.50
|
182.52 pg/ml
Standard Deviation 73.72
|
|
Peripheral Markers of Inflammation
IL17A at T1
|
1.01 pg/ml
Standard Deviation 1.26
|
1.28 pg/ml
Standard Deviation 1.44
|
1.06 pg/ml
Standard Deviation 1.14
|
|
Peripheral Markers of Inflammation
IFN gamma at T2
|
6.09 pg/ml
Standard Deviation 4.07
|
7.57 pg/ml
Standard Deviation 9.55
|
6.07 pg/ml
Standard Deviation 3.98
|
|
Peripheral Markers of Inflammation
IFN gamma at T3
|
4.67 pg/ml
Standard Deviation 3.61
|
4.44 pg/ml
Standard Deviation 2.34
|
4.53 pg/ml
Standard Deviation 3.35
|
|
Peripheral Markers of Inflammation
TNFalpha at T3
|
0.94 pg/ml
Standard Deviation 0.23
|
0.86 pg/ml
Standard Deviation 0.22
|
0.98 pg/ml
Standard Deviation 0.33
|
|
Peripheral Markers of Inflammation
IL6 at T1
|
0.38 pg/ml
Standard Deviation 0.13
|
0.39 pg/ml
Standard Deviation 0.22
|
0.42 pg/ml
Standard Deviation 0.19
|
|
Peripheral Markers of Inflammation
IL12P70 at T2
|
0.04 pg/ml
Standard Deviation 0.03
|
0.05 pg/ml
Standard Deviation 0.04
|
0.07 pg/ml
Standard Deviation 0.04
|
|
Peripheral Markers of Inflammation
IL12P70 at T3
|
0.05 pg/ml
Standard Deviation 0.03
|
0.04 pg/ml
Standard Deviation 0.04
|
0.05 pg/ml
Standard Deviation 0.03
|
|
Peripheral Markers of Inflammation
IL6 at T2
|
0.44 pg/ml
Standard Deviation 0.19
|
0.44 pg/ml
Standard Deviation 0.40
|
0.48 pg/ml
Standard Deviation 0.24
|
|
Peripheral Markers of Inflammation
IL8 at T1
|
1.94 pg/ml
Standard Deviation 0.62
|
2.09 pg/ml
Standard Deviation 1.04
|
1.89 pg/ml
Standard Deviation 0.72
|
|
Peripheral Markers of Inflammation
IL8 at PP
|
3.28 pg/ml
Standard Deviation 1.40
|
3.45 pg/ml
Standard Deviation 0.92
|
3.33 pg/ml
Standard Deviation 1.68
|
|
Peripheral Markers of Inflammation
IL10 at T2
|
0.16 pg/ml
Standard Deviation 0.06
|
0.21 pg/ml
Standard Deviation 0.14
|
0.26 pg/ml
Standard Deviation 0.36
|
|
Peripheral Markers of Inflammation
IL10 at T3
|
0.26 pg/ml
Standard Deviation 0.20
|
0.19 pg/ml
Standard Deviation 0.09
|
0.25 pg/ml
Standard Deviation 0.31
|
|
Peripheral Markers of Inflammation
IL10 at PP
|
0.30 pg/ml
Standard Deviation 0.35
|
0.22 pg/ml
Standard Deviation 0.15
|
0.21 pg/ml
Standard Deviation 0.20
|
|
Peripheral Markers of Inflammation
IL12P70 at T1
|
0.04 pg/ml
Standard Deviation 0.03
|
0.05 pg/ml
Standard Deviation 0.03
|
0.51 pg/ml
Standard Deviation 0.03
|
|
Peripheral Markers of Inflammation
IL12P70 at PP
|
0.05 pg/ml
Standard Deviation 0.05
|
0.04 pg/ml
Standard Deviation 0.06
|
0.06 pg/ml
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: trimester 2, trimester 3, 6 weeks postpartumPopulation: 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).
Outcome measures
| Measure |
Anxious Pregnant Women - Intervention Group
n=21 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=25 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=50 Participants
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.
|
|---|---|---|---|
|
Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
Allopregnanolone at T3
|
2.825177 log (ng/ml)
Standard Deviation 0.995552
|
3.149545 log (ng/ml)
Standard Deviation 0.3715666
|
3.048794 log (ng/ml)
Standard Deviation 0.3715666
|
|
Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
Allopregnanolone at T2
|
-0.3796214 log (ng/ml)
Standard Deviation 0.7621596
|
-0.3828328 log (ng/ml)
Standard Deviation 0.8335611
|
-0.2820709 log (ng/ml)
Standard Deviation 0.9410302
|
|
Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
Allopregnanolone at W6
|
-0.592519 log (ng/ml)
Standard Deviation 0.5954829
|
-0.6423627 log (ng/ml)
Standard Deviation 0.5764104
|
-0.7948805 log (ng/ml)
Standard Deviation 0.4380674
|
PRIMARY outcome
Timeframe: Trimester 2Population: 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.
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.
Outcome measures
| Measure |
Anxious Pregnant Women - Intervention Group
n=19 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=21 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=41 Participants
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.
|
|---|---|---|---|
|
Allopregnanolone Levels Predicting Postpartum Depression
Allopregnanolone at T2 in women with PPD
|
-0.004127186 log (ng/ml)
Standard Deviation 0.7631303
|
-0.8292861 log (ng/ml)
Standard Deviation 0.7694288
|
—
|
|
Allopregnanolone Levels Predicting Postpartum Depression
Allopregnanolone at T2 in women without PPD
|
-0.4591347 log (ng/ml)
Standard Deviation 0.7616261
|
-0.08843005 log (ng/ml)
Standard Deviation 0.7569726
|
-0.1739193 log (ng/ml)
Standard Deviation 0.9115309
|
PRIMARY outcome
Timeframe: trimester 2, trimester 3, 6 weeks postpartumPopulation: Trimester 2, 3, 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))
Outcome measures
| Measure |
Anxious Pregnant Women - Intervention Group
n=21 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=25 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=50 Participants
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.
|
|---|---|---|---|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_EOTAXIN
|
0.607838873 p value
|
0.508436643 p value
|
0.731221724 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_IFNgam
|
0.943495625 p value
|
0.962951805 p value
|
0.32767424 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_IL10
|
0.442764509 p value
|
0.852343415 p value
|
0.251810201 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_IL12P70
|
0.043026211 p value
|
0.182583506 p value
|
0.032112919 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_IL17A
|
0.994071069 p value
|
0.628278059 p value
|
0.155033717 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_IL6
|
0.661240061 p value
|
0.433900134 p value
|
0.101928485 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_IL8
|
0.58507263 p value
|
0.377422318 p value
|
0.000902406 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_MCP4
|
0.253876939 p value
|
0.975614712 p value
|
0.261553 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_MIP1alp
|
0.211464436 p value
|
0.219395666 p value
|
0.757648777 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_TARC
|
0.044208627 p value
|
0.09877797 p value
|
0.482216914 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T2 Allo and T2_TNFalp
|
0.620118634 p value
|
0.452187217 p value
|
0.389716682 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_EOTAXIN
|
0.438406999 p value
|
0.484822182 p value
|
0.644129208 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_IFNgam
|
0.404728602 p value
|
0.373945489 p value
|
0.747287036 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_IL10
|
0.119629591 p value
|
0.335957072 p value
|
0.299247829 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_IL12P70
|
0.933378078 p value
|
0.337344443 p value
|
0.898094409 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_IL17A
|
0.771455608 p value
|
0.280587079 p value
|
0.412507598 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_IL6
|
0.663796915 p value
|
0.083926433 p value
|
0.526805187 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_IL8
|
0.681722947 p value
|
0.570578156 p value
|
0.447858 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_MCP4
|
0.725048008 p value
|
0.420134106 p value
|
0.090351732 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_MIP1alp
|
0.40714722 p value
|
0.241913557 p value
|
0.454254606 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_TARC
|
0.12961388 p value
|
0.420828347 p value
|
0.604242922 p value
|
|
Allopregnanolone (ALLO) and Immune Function
T3 Allo and T3_TNFalp
|
0.25342432 p value
|
0.921598373 p value
|
0.981377152 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_EOTAXIN
|
0.056363143 p value
|
0.488055787 p value
|
0.00049734 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_IFNgam
|
0.778831242 p value
|
0.493655855 p value
|
0.019717559 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_IL10
|
0.380554726 p value
|
0.706511155 p value
|
0.038619177 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_IL12P70
|
0.434897804 p value
|
0.707672478 p value
|
0.086203475 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_IL17A
|
0.803123246 p value
|
0.514072112 p value
|
0.132466231 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_IL6
|
0.653576209 p value
|
0.999655946 p value
|
0.174873815 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_IL8
|
0.965403419 p value
|
0.224965514 p value
|
0.183430195 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_MCP4
|
0.752085053 p value
|
0.54436977 p value
|
0.42633973 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_MIP1alp
|
0.134643876 p value
|
0.277197163 p value
|
0.571967334 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_TARC
|
0.065203743 p value
|
0.923420368 p value
|
0.922589566 p value
|
|
Allopregnanolone (ALLO) and Immune Function
W6 Allo and W6_TNFalp
|
0.286463458 p value
|
0.694997299 p value
|
0.965333979 p value
|
SECONDARY outcome
Timeframe: at birthPopulation: The number analyzed is different than the overall number because data was not collected.
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.
Outcome measures
| Measure |
Anxious Pregnant Women - Intervention Group
n=26 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=31 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=60 Participants
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.
|
|---|---|---|---|
|
Birth Outcomes
preterm birth
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Birth Outcomes
small for gestational age
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Birth Outcomes
low birth weight
|
11 Participants
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: The number analyzed is different than the overall number because data was not collected.
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
Outcome measures
| Measure |
Anxious Pregnant Women - Intervention Group
n=26 Participants
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=31 Participants
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.
|
Non-anxious Pregnant Women - Healthy Control
n=60 Participants
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.
|
|---|---|---|---|
|
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
communication below cut-off score
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
gross motor below cut-off score
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
fine motor below cut-off score
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
personal-social below cut-off score
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
problem solving below cut-off score
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Anxious Pregnant Women - Intervention Group
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Anxious Pregnant Women - Enhanced Usual Care Group
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-anxious Pregnant Women - Healthy Control
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anxious Pregnant Women - Intervention Group
n=26 participants at risk
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.
|
Anxious Pregnant Women - Enhanced Usual Care Group
n=31 participants at risk
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.
|
Non-anxious Pregnant Women - Healthy Control
n=60 participants at risk
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.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Still birth
|
3.8%
1/26 • Number of events 1 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
3.2%
1/31 • Number of events 1 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
1.7%
1/60 • Number of events 1 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
30.8%
8/26 • Number of events 8 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
38.7%
12/31 • Number of events 12 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
28.3%
17/60 • Number of events 17 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
|
Pregnancy, puerperium and perinatal conditions
Child death
|
0.00%
0/26 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
3.2%
1/31 • Number of events 1 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
3.3%
2/60 • Number of events 2 • 5 months
We only had still births, miscarriages and child deaths of the participants who were giving births
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pamela Surkan
Johns Hopkins Bloomberg School of Public Health
Phone: 4105027396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place