Preterm Birth
Conditions
Brief summary
The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.
Detailed description
The study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant NHB women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. Consenting participants will be randomized to the intervention or an active control. The intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the IP3, 2) structured encouragement via text messages and 3) employment law education sheet. The powerpoints will also be available for review on our you-tube channel for intervention patients. The active control arm includes: 1) a narrated powerpoint describing the Duke Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e. it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index. The team will collect feedback on the intervention based on an intake questionnaire and an exit interview. Information will also be collected on adherence to the IP3 based on review of the participant's medical record. The primary aim of the study is to evaluation feasibility and acceptability. These endpoints will be measured via enrollment and participant feedback during the exit interview.
Interventions
BEHAVIORALIntervention Arm Weekly IP3 text messages
Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.
OTHERActive Control Arm General pregnancy text messages
Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention Arm vs. Active Control Arm
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* self described race as Non-Hispanic Black * history of prior singleton preterm delivery (before 37 weeks gestation) * current singleton gestation
Exclusion criteria
* women with anomalous fetuses * age below 18\] * non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Number of Recruited Eligible Patients Enrolled | study duration (approximately 14 months) | Enrollment target of 30% of eligible patients recruited. |
| Acceptability as Measured by Number of Participants Who Completed the Study | study duration (approximately 14 months) | Completion target of 80% participants retained in study protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | protocol completion (approximately 1 year) | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive). |
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain | protocol completion (approximately 1 year) | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient). |
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | protocol completion (approximately 1 year) | The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative). |
| Change in Maternal Social Support Scale (MSSS) | baseline to protocol completion (approximately 1 year) | The MSSS is a six-question scale that quantifies a pregnant woman's social support. Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale. The total possible score for the scale is between 6 and 30, with higher scores indicating increased support. |
| IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance | approximately 1 year | — |
| Birth Weight in Grams | approximately 40 weeks | — |
| Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | approximately 40 weeks | — |
| Length of Delivery Hospital Admission in Days | approximately 40 weeks | — |
| Gestational Age at Delivery in Weeks | approximately 40 weeks | — |
| Pregnancy Specific Anxiety (PSA) | baseline, 28 weeks | Pregnancy specific anxiety is a 4-question scale. Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5. Higher scores are negative and denote increased anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm: Weekly IP3 Text Messages * A narrated powerpoint presentation describing the logistical details and medical rationale for components of the IP3. Participants will view the chapters of the presentation that are relevant to their specific IP3. There are a total of 4 possible chapters (lifestyle modifications, cervix length screening/cerclage, progesterone therapy, low dose aspirin). Each chapter of the presentation is \
10 - 15 min in length. Each chapter also includes a 4- 5 questions pre-test and the same questions are delivered as a post-test after the presentation.
* Print materials including a letter explaining the importance of prenatal care for preterm birth prevention to employers.
* Text messages sent weekly to encourage the patient to continue with their IP3 and provide basic pregnancy information
* Formal letter of encouragement from provider at 28 weeks gestation
Intervention Arm Weekly IP3 text messages: Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3. | 14 |
| Control Arm: General Pregnancy Text Messages * a pre-intervention questionnaire
* a narrated powerpoint with general information about the clinic
* a post-presentation questionnaire
* text messages sent approximately weekly with general pregnancy information (e.g. today your baby is about the size of an apple)
* an exit interview
Active Control Arm General pregnancy text messages: Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information. | 16 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Arm: Weekly IP3 Text Messages | Total | Control Arm: General Pregnancy Text Messages |
|---|---|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 5.3 | 31.5 years STANDARD_DEVIATION 6.2 | 32.1 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 30 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Female | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
Acceptability as Measured by Number of Participants Who Completed the Study
Completion target of 80% participants retained in study protocol.
Time frame: study duration (approximately 14 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients Recruited | Acceptability as Measured by Number of Participants Who Completed the Study | 12 Participants |
| Control Arm: General Pregnancy Text Messages | Acceptability as Measured by Number of Participants Who Completed the Study | 16 Participants |
Primary
Feasibility as Measured by Number of Recruited Eligible Patients Enrolled
Enrollment target of 30% of eligible patients recruited.
Time frame: study duration (approximately 14 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients Recruited | Feasibility as Measured by Number of Recruited Eligible Patients Enrolled | 30 Participants |
Secondary
Birth Weight in Grams
Time frame: approximately 40 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients Recruited | Birth Weight in Grams | 2442.5 grams | Standard Deviation 1255.9 |
| Control Arm: General Pregnancy Text Messages | Birth Weight in Grams | 2607.9 grams | Standard Deviation 750.6 |
Secondary
Change in Maternal Social Support Scale (MSSS)
The MSSS is a six-question scale that quantifies a pregnant woman's social support. Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale. The total possible score for the scale is between 6 and 30, with higher scores indicating increased support.
Time frame: baseline to protocol completion (approximately 1 year)
Population: Participants who completed the MSSS questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients Recruited | Change in Maternal Social Support Scale (MSSS) | 0.1 score on a scale | Standard Deviation 1.5 |
| Control Arm: General Pregnancy Text Messages | Change in Maternal Social Support Scale (MSSS) | -1.4 score on a scale | Standard Deviation 2.4 |
Secondary
Gestational Age at Delivery in Weeks
Time frame: approximately 40 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients Recruited | Gestational Age at Delivery in Weeks | 34.0 weeks | Standard Deviation 6.1 |
| Control Arm: General Pregnancy Text Messages | Gestational Age at Delivery in Weeks | 35.7 weeks | Standard Deviation 3.5 |
Secondary
Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain
The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive).
Time frame: protocol completion (approximately 1 year)
Population: Participants who completed the IPC-18 questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | Lack of clarity | 1.6 score on a scale | Standard Deviation 0.6 |
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | Elicits concern | 4.6 score on a scale | Standard Deviation 0.6 |
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | Explain results | 4.5 score on a scale | Standard Deviation 0.6 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | Lack of clarity | 1.6 score on a scale | Standard Deviation 1.1 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | Elicits concern | 4.7 score on a scale | Standard Deviation 0.6 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain | Explain results | 4.6 score on a scale | Standard Deviation 0.7 |
Secondary
Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain
The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient).
Time frame: protocol completion (approximately 1 year)
Population: Participants who completed the IPC-18 questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain | 4.4 score on a scale | Standard Deviation 1.1 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain | 4.8 score on a scale | Standard Deviation 0.4 |
Secondary
Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain
The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' Item responses are averaged, not summed; thus, scores have a possible range of 1-5. All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative).
Time frame: protocol completion (approximately 1 year)
Population: Participants who completed the IPC-18 questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | Emotional support | 4.7 score on a scale | Standard Deviation 0.5 |
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | Discrimination due to race/ethnicity | 1.5 score on a scale | Standard Deviation 0.7 |
| Eligible Patients Recruited | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | Disrespectful to office staff | 1.2 score on a scale | Standard Deviation 0.3 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | Emotional support | 4.8 score on a scale | Standard Deviation 0.4 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | Discrimination due to race/ethnicity | 1.3 score on a scale | Standard Deviation 0.8 |
| Control Arm: General Pregnancy Text Messages | Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain | Disrespectful to office staff | 1.1 score on a scale | Standard Deviation 0.5 |
Secondary
IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance
Time frame: approximately 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients Recruited | IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance | 1 Participants |
| Control Arm: General Pregnancy Text Messages | IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance | 3 Participants |
Secondary
Length of Delivery Hospital Admission in Days
Time frame: approximately 40 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eligible Patients Recruited | Length of Delivery Hospital Admission in Days | 2 days |
| Control Arm: General Pregnancy Text Messages | Length of Delivery Hospital Admission in Days | 3 days |
Secondary
Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)
Time frame: approximately 40 weeks
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Eligible Patients Recruited | Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | 5 Neonates |
| Control Arm: General Pregnancy Text Messages | Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | 4 Neonates |
Secondary
Pregnancy Specific Anxiety (PSA)
Pregnancy specific anxiety is a 4-question scale. Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5. Higher scores are negative and denote increased anxiety.
Time frame: baseline, 28 weeks
Population: Participants who completed the PSA questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Patients Recruited | Pregnancy Specific Anxiety (PSA) | Baseline | 2.6 score on a scale | Standard Deviation 1 |
| Eligible Patients Recruited | Pregnancy Specific Anxiety (PSA) | 28 Weeks | 2.3 score on a scale | Standard Deviation 0.9 |
| Control Arm: General Pregnancy Text Messages | Pregnancy Specific Anxiety (PSA) | Baseline | 2.4 score on a scale | Standard Deviation 0.9 |
| Control Arm: General Pregnancy Text Messages | Pregnancy Specific Anxiety (PSA) | 28 Weeks | 2.3 score on a scale | Standard Deviation 0.6 |