Trial Outcomes & Findings for Tennessee Connections for Better Birth Outcomes (NCT NCT00502697)
NCT ID: NCT00502697
Last Updated: 2017-04-07
Results Overview
Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
236 participants
Primary outcome timeframe
Time of delivery
Results posted on
2017-04-07
Participant Flow
The sample consisted of pregnant women receiving prenatal care with a (physician or nurse-midwife) at a large regional medical center in the Southeastern U.S. from April, 2007 through January, 2010.
Participant milestones
| Measure |
Intervention Group
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
|
Control Group
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care.
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
114
|
|
Overall Study
COMPLETED
|
109
|
102
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
Intervention Group
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
|
Control Group
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
disenrolled due to pregnancy loss
|
3
|
5
|
|
Overall Study
found not to meet eligibility criteria
|
3
|
4
|
|
Overall Study
did not meet assignment criteria
|
4
|
2
|
Baseline Characteristics
Tennessee Connections for Better Birth Outcomes
Baseline characteristics by cohort
| Measure |
Treatment Group
n=109 Participants
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
|
Control Group
n=102 Participants
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
27.8 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
27.6 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=5 Participants
|
102 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Marital Status
Married or Partnered
|
78 participants
n=5 Participants
|
75 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Marital Status
Divorced or Separated
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Marital Status
Never Married
|
27 participants
n=5 Participants
|
19 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Type of insurance
Medicaid
|
64 participants
n=5 Participants
|
62 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Type of insurance
Private/Champus
|
44 participants
n=5 Participants
|
36 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Type of insurance
None/self pay
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Type of insurance
Unknown or not reported
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Level of education in years
|
13.2 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
13.3 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Gestational age at enrollment in weeks
|
15.43 weeks
STANDARD_DEVIATION 4.57 • n=5 Participants
|
15.29 weeks
STANDARD_DEVIATION 4.57 • n=7 Participants
|
15.43 weeks
STANDARD_DEVIATION 4.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: Time of deliveryPopulation: ITT analysis used with all participants that birth information could be obtained.
Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.
Outcome measures
| Measure |
Intervention Group
n=108 Participants
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
|
Control Group
n=102 Participants
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care.
|
|---|---|---|
|
Infant Gestational Age
|
38.14 weeks
Interval 36.57 to 39.29
|
38.14 weeks
Interval 36.29 to 39.14
|
SECONDARY outcome
Timeframe: Hospital discharge point following deliveryPopulation: Of the 211 participants, data on length of stay at delivery were available for 194 women. The most common reason for the lack of this information was that the birth did not take place at the study's medical center.
Number of maternal hospital days associated with delivery
Outcome measures
| Measure |
Intervention Group
n=101 Participants
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
|
Control Group
n=93 Participants
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care.
|
|---|---|---|
|
Maternal Length of Stay at Delivery
|
2 days
Interval 1.0 to 12.0
|
3 days
Interval 0.0 to 40.0
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melanie Lutenbacher, PhD, MSN, FAAN
Vanderbilt University
Phone: 615-343-3314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place