Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 80 of 136 for:    (domestic or partner) AND (violence OR abuse)

Tennessee Connections for Better Birth Outcomes (BBO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00502697
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : March 16, 2016
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Blue Cross Blue Shield
Nurses for Newborns Foundation
Information provided by (Responsible Party):
Melanie Lutenbacher, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Preterm Birth
Interventions Behavioral: Targeted Nurse Home Visits
Other: Conventional prenatal/postpartum care
Enrollment 236
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 122 114
Completed 109 102
Not Completed 13 12
Reason Not Completed
Withdrawal by Subject             3             1
disenrolled due to pregnancy loss             3             5
found not to meet eligibility criteria             3             4
did not meet assignment criteria             4             2
Arm/Group Title Treatment Group Control Group Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 109 102 211
Hide Baseline Analysis Population Description
We analyzed data for participants who remained in the study for at least four weeks following enrollment. The final sample totaled 211 women: 109 intervention and 102 controls.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 102 participants 211 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
109
 100.0%
102
 100.0%
211
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 102 participants 211 participants
27.4  (5.5) 27.8  (5.2) 27.6  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 102 participants 211 participants
Female
109
 100.0%
102
 100.0%
211
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 102 participants 211 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
41
  37.6%
34
  33.3%
75
  35.5%
White
67
  61.5%
67
  65.7%
134
  63.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.9%
1
   1.0%
2
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants 102 participants 211 participants
109 102 211
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 102 participants 211 participants
Married or Partnered 78 75 153
Divorced or Separated 4 8 12
Never Married 27 19 46
Type of insurance  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 102 participants 211 participants
Medicaid 64 62 126
Private/Champus 44 36 80
None/self pay 0 3 3
Unknown or not reported 1 1 2
Level of education in years  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 102 participants 211 participants
13.2  (2.5) 13.4  (2.6) 13.3  (2.6)
Gestational age at enrollment in weeks  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 109 participants 102 participants 211 participants
15.43  (4.57) 15.29  (4.57) 15.43  (4.57)
1.Primary Outcome
Title Infant Gestational Age
Hide Description Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.
Time Frame Time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis used with all participants that birth information could be obtained.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 108 102
Median (Inter-Quartile Range)
Unit of Measure: weeks
38.14
(36.57 to 39.29)
38.14
(36.29 to 39.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Maternal Length of Stay at Delivery
Hide Description Number of maternal hospital days associated with delivery
Time Frame Hospital discharge point following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 101 93
Median (Full Range)
Unit of Measure: days
2
(1 to 12)
3
(0 to 40)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/114 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/114 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Melanie Lutenbacher, PhD, MSN, FAAN
Organization: Vanderbilt University
Phone: 615-343-3314
Responsible Party: Melanie Lutenbacher, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00502697     History of Changes
Other Study ID Numbers: 070684
First Submitted: July 16, 2007
First Posted: July 18, 2007
Results First Submitted: April 13, 2015
Results First Posted: March 16, 2016
Last Update Posted: April 7, 2017