Trial Outcomes & Findings for Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders (NCT NCT03808909)
NCT ID: NCT03808909
Last Updated: 2022-11-30
Results Overview
Number of participants who complete the 2 week follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
2 week postpartum follow-up assessment
Results posted on
2022-11-30
Participant Flow
Participant milestones
| Measure |
Doula
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
Participants will not be assigned a doula.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
1
|
|
Overall Study
COMPLETED
|
9
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Doula
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
Participants will not be assigned a doula.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Baseline characteristics by cohort
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Percent Drinking Days
|
0 Percent of days
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent of days
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Percent of days
STANDARD_DEVIATION 0 • n=5 Participants
|
|
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
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
1 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Edinburgh Postpartum Depression Scale
|
12.11 units on a scale
STANDARD_DEVIATION 5.6667 • n=5 Participants
|
18 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
12.70 units on a scale
STANDARD_DEVIATION 5.65784 • n=5 Participants
|
|
PTSD Checklist - 5 (PCL-5)
|
35.56 units on a scale
STANDARD_DEVIATION 23.591 • n=5 Participants
|
23 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
34.30 units on a scale
STANDARD_DEVIATION 22.593 • n=5 Participants
|
|
Percent Substance Use Days
|
52.75 Percent of days
STANDARD_DEVIATION 56.372 • n=5 Participants
|
0 Percent of days
STANDARD_DEVIATION 0 • n=7 Participants
|
47.47 Percent of days
STANDARD_DEVIATION 55.704 • n=5 Participants
|
|
NIH Toolbox Emotional Support
|
33.00 units on a scale
STANDARD_DEVIATION 6.727 • n=5 Participants
|
9 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
30.60 units on a scale
STANDARD_DEVIATION 9.891 • n=5 Participants
|
|
NIH Toolbox Friendship Support
|
17.89 units on a scale
STANDARD_DEVIATION 5.578 • n=5 Participants
|
8 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
16.90 units on a scale
STANDARD_DEVIATION 6.118 • n=5 Participants
|
|
NIH Toolbox Instrumental Support
|
29.22 units on a scale
STANDARD_DEVIATION 5.740 • n=5 Participants
|
8 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
27.10 units on a scale
STANDARD_DEVIATION 8.621 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 week postpartum follow-up assessmentNumber of participants who complete the 2 week follow-up
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Number of Participants Who Remain in the Study
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: birthNumber of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Alternative Birth Outcome
C-section
|
2 Participants
|
1 Participants
|
|
Alternative Birth Outcome
Preterm Birth
|
1 Participants
|
0 Participants
|
|
Alternative Birth Outcome
Fetal Demise
|
0 Participants
|
0 Participants
|
|
Alternative Birth Outcome
Stillbirth
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 week postpartum follow-up assessmentPTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Postpartum Posttraumatic Stress Disorder Checklist
|
21.38 score on a scale
Standard Deviation 20.007
|
50 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 2 week postpartum follow-up assessmentPopulation: Participants who were assigned a doula were included in this analysis
Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
Participants will not be assigned a doula.
|
|---|---|---|
|
Participant Satisfaction
Percent of participants who found it very helpful emotionally to have a doula during labor/delivery
|
89 percentage of participants
|
—
|
|
Participant Satisfaction
Percent of participants who found it very helpful physically to have a doula during labor/delivery
|
89 percentage of participants
|
—
|
|
Participant Satisfaction
Percent of participants who found it very helpful socially to have a doula during labor/delivery
|
100 percentage of participants
|
—
|
|
Participant Satisfaction
Percent of participants who would want a doula at another birth
|
100 percentage of participants
|
—
|
|
Participant Satisfaction
Percent of participants who felt having a doula made pregnancy much easier
|
89 percentage of participants
|
—
|
|
Participant Satisfaction
Percent of participants who felt the doula understood their needs very well
|
89 percentage of participants
|
—
|
|
Participant Satisfaction
Percent of participants who were very satisfied with the doula experience
|
100 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 week postpartum follow-up assessmentUsing the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up.
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Percentage of Days With Drinking or Substance Use
|
19.85 percentage of days
Standard Deviation 44.509
|
0 percentage of days
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: queries feelings during labor and birth but is administered at 2 week follow-upMother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Mother's Autonomy During Birth
|
30.8889 score on a scale
Standard Deviation 11.66667
|
38 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 week postpartum follow-up assessmentEdinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Postpartum Depression
|
8.56 score on a scale
Standard Deviation 6.579
|
18 score on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 week postpartum follow-up assessmentUsing a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Breastfeeding Update
Breastfeeding intent
|
3 Participants
|
1 Participants
|
|
Breastfeeding Update
Breastfeeding initiation
|
9 Participants
|
1 Participants
|
|
Breastfeeding Update
Breastfeeding at discharge
|
9 Participants
|
1 Participants
|
|
Breastfeeding Update
Exclusive breastfeeding
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: neonatalNAS diagnosis
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Neonatal Abstinence Syndrome
|
6 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from birth through study completion, an average of 3 monthsAverage length of time that the infant remains hospitalized in the NICU after the birth
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Length of NICU Stay
|
11.56 Days
Standard Deviation 14.32
|
4 Days
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 week postpartum follow-up assessmentAverage score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120
Outcome measures
| Measure |
Doula
n=9 Participants
Participants will be assigned a doula.
Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
|
Control
n=1 Participants
Participants will not be assigned a doula.
|
|---|---|---|
|
Social Support - NIH Toolbox
|
82.3333 score on a scale
Standard Deviation 19.62142
|
25 score on a scale
Standard Deviation 0
|
Adverse Events
Doula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Doula
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
Pilar Sanjuan
University of New Mexico, Health Sciences Center
Phone: 505/272-7055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place