An interventional study of Intervention Arm Weekly IP3 text messages and Active Control Arm General pregnancy text messages in Preterm Birth, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 30 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
* 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
Behavioral: Intervention Arm Weekly IP3 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
Other: Active Control Arm General pregnancy 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.
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.
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)
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)
IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance
Time frame: approximately 1 year
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
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)
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)
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)
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)
Gestational Age at Delivery in Weeks
Time frame: approximately 40 weeks
Birth Weight in Grams
Time frame: approximately 40 weeks
Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)
Time frame: approximately 40 weeks
Length of Delivery Hospital Admission in Days
Time frame: approximately 40 weeks
| Milestone | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Started | 14 | 16 |
| Completed | 12 | 16 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Enrollment target of 30% of eligible patients recruited.
| Participants | Eligible Patients Recruited |
|---|---|
| Feasibility as Measured by Number of Recruited Eligible Patients Enrolled | 30 |
Completion target of 80% participants retained in study protocol.
| Participants | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Acceptability as Measured by Number of Participants Who Completed the Study | 12 | 16 |
| Participants | Intervention Arm: Weekly IP3 Text Messages | 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 | 1 | 3 |
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.
| score on a scale | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Baseline | 2.6 ± 1.0 | 2.4 ± 0.9 |
| 28 Weeks | 2.3 ± 0.9 | 2.3 ± 0.6 |
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).
| score on a scale | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Lack of clarity | 1.6 ± 0.6 | 1.6 ± 1.1 |
| Elicits concern | 4.6 ± 0.6 | 4.7 ± 0.6 |
| Explain results | 4.5 ± 0.6 | 4.6 ± 0.7 |
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).
| score on a scale | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain | 4.4 ± 1.1 | 4.8 ± 0.4 |
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).
| score on a scale | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Emotional support | 4.7 ± 0.5 | 4.8 ± 0.4 |
| Discrimination due to race/ethnicity | 1.5 ± 0.7 | 1.3 ± 0.8 |
| Disrespectful to office staff | 1.2 ± 0.3 | 1.1 ± 0.5 |
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.
| score on a scale | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Change in Maternal Social Support Scale (MSSS) | 0.1 ± 1.5 | -1.4 ± 2.4 |
| weeks | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Gestational Age at Delivery in Weeks | 34.0 ± 6.1 | 35.7 ± 3.5 |
| grams | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Birth Weight in Grams | 2442.5 ± 1255.9 | 2607.9 ± 750.6 |
| Neonates | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU) | 5 | 4 |
| days | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages |
|---|---|---|
| Length of Delivery Hospital Admission in Days | 2 (2 to 3) | 3 (2 to 3) |
Collected over Approximately 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm: Weekly IP3 Text Messages | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Control Arm: General Pregnancy Text Messages | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages | Total |
|---|---|---|---|
| Mean | 30.9 ± 5.3 | 32.1 ± 7.0 | 31.5 ± 6.2 |
| Sex: Female, Male(Participants) | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 14 | 16 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 16 | 30 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Intervention Arm: Weekly IP3 Text Messages | Control Arm: General Pregnancy Text Messages | Total |
|---|---|---|---|
| United States | 14 | 16 | 30 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Feb 2020 to primary completion in Apr 2021, 14 months.
Results were first posted in Nov 2022, 1 year 7 months after primary completion.
Of 753 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 14 months is below that.
Counting every sponsor, half of 775 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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