Trial Outcomes & Findings for Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health (NCT NCT02371356)

NCT ID: NCT02371356

Last Updated: 2020-03-18

Results Overview

Delivery prior to 37 completed weeks of gestational age

Recruitment status

COMPLETED

Target enrollment

91084 participants

Primary outcome timeframe

Through the end of pregnancy, an average of 40 weeks

Results posted on

2020-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Depressed, Medication Only Screen positive for depression and use only antidepressants during pregnancy	Depressed, Psychotherapy Only Screen positive for depression and receive psychotherapy only	Depressed, Medication & Psychotherapy Screen positive for depression and receive both antidepressants and psychotherapy	Depressed, Untreated Screen positive for depression and receive no treatment	Not Depressed Screen negative for depression and received no treatment
Overall Study STARTED	1320	7354	2804	7423	72183
Overall Study COMPLETED	1320	7354	2804	7423	72183
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depressed, Medication Only n=1320 Participants Screen positive for depression and use only antidepressants during pregnancy	Depressed, Psychotherapy Only n=7354 Participants Screen positive for depression and receive psychotherapy only	Depressed, Medication & Psychotherapy n=2804 Participants Screen positive for depression and receive both antidepressants and psychotherapy	Depressed, Untreated n=7423 Participants Screen positive for depression and receive no treatment	Not Depressed n=72183 Participants Screen negative for depression and received no treatment	Total n=91084 Participants Total of all reporting groups
Age, Customized Maternal Age · 18-24 years	156 Participants n=5 Participants	1792 Participants n=7 Participants	400 Participants n=5 Participants	1123 Participants n=4 Participants	8987 Participants n=21 Participants	12458 Participants n=10 Participants
Age, Customized Maternal Age · 25-34 years	721 Participants n=5 Participants	4117 Participants n=7 Participants	1654 Participants n=5 Participants	4440 Participants n=4 Participants	46148 Participants n=21 Participants	57080 Participants n=10 Participants
Age, Customized Maternal Age · 35+ years	443 Participants n=5 Participants	1445 Participants n=7 Participants	750 Participants n=5 Participants	1860 Participants n=4 Participants	17048 Participants n=21 Participants	21546 Participants n=10 Participants
Sex: Female, Male Female	1320 Participants n=5 Participants	7354 Participants n=7 Participants	2804 Participants n=5 Participants	7423 Participants n=4 Participants	72183 Participants n=21 Participants	91084 Participants n=10 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	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized Maternal Race/ethnicity · White	813 Participants n=5 Participants	2638 Participants n=7 Participants	1610 Participants n=5 Participants	2257 Participants n=4 Participants	26385 Participants n=21 Participants	33703 Participants n=10 Participants
Race/Ethnicity, Customized Maternal Race/ethnicity · Asian	103 Participants n=5 Participants	1147 Participants n=7 Participants	165 Participants n=5 Participants	1957 Participants n=4 Participants	19697 Participants n=21 Participants	23069 Participants n=10 Participants
Race/Ethnicity, Customized Maternal Race/ethnicity · African-American	55 Participants n=5 Participants	945 Participants n=7 Participants	248 Participants n=5 Participants	577 Participants n=4 Participants	3773 Participants n=21 Participants	5598 Participants n=10 Participants
Race/Ethnicity, Customized Maternal Race/ethnicity · Hispanic	283 Participants n=5 Participants	2200 Participants n=7 Participants	621 Participants n=5 Participants	2208 Participants n=4 Participants	18545 Participants n=21 Participants	23857 Participants n=10 Participants
Race/Ethnicity, Customized Maternal Race/ethnicity · Other/multiple/unknown	66 Participants n=5 Participants	424 Participants n=7 Participants	160 Participants n=5 Participants	424 Participants n=4 Participants	3783 Participants n=21 Participants	4857 Participants n=10 Participants
Region of Enrollment United States	1320 Participants n=5 Participants	7354 Participants n=7 Participants	2804 Participants n=5 Participants	7423 Participants n=4 Participants	72183 Participants n=21 Participants	91084 Participants n=10 Participants

PRIMARY outcome

Timeframe: Through the end of pregnancy, an average of 40 weeks

Delivery prior to 37 completed weeks of gestational age

Outcome measures

Outcome measures
Measure	Depressed, Medication Only n=1320 Participants Screen positive for depression and use only antidepressants during pregnancy	Depressed, Psychotherapy Only n=7354 Participants Screen positive for depression and receive psychotherapy only	Depressed, Medication & Psychotherapy n=2804 Participants Screen positive for depression and receive both antidepressants and psychotherapy	Depressed, Untreated n=7423 Participants Screen positive for depression and receive no treatment	Not Depressed n=72183 Participants Screen negative for depression and received no treatment
Preterm Delivery Preterm	139 Participants	556 Participants	272 Participants	569 Participants	4164 Participants
Preterm Delivery Not preterm	1181 Participants	6798 Participants	2532 Participants	6854 Participants	68019 Participants

PRIMARY outcome

Timeframe: Through the end of pregnancy, an average of 40 weeks

Population: Those with missing birth weight information were excluded from the analysis of low birth weight

Birth weight \<2500 grams