Premature BirthNCT04093492
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
A study testing Preemie Prep for Parents (P3) Outpatient Mobile Intervention and ACOG links in people with Premature Birth and Decision Making, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Decision Making, Prenatal Care
- What is being tested?
- Preemie Prep for Parents (P3) Outpatient Mobile Intervention and ACOG links
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman or her partner
- At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications.
- Gestational age of 16-21 weeks at recruitment.
- Owns a smartphone.
- Able to speak English
Who cannot join
- Pregnancies with known significant birth defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.
Read the detailed description
This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making.
Participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age.
At study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.
- Being tested
- Preemie Prep for Parents (P3) Outpatient Mobile Intervention, ACOG links
- Keywords
- gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation
- Medical subject headings
- Premature Birth, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemie Prep for Parents (P3) Outpatient Mobile InterventionOther
The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.
ACOG linksOther
Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.
| Study group | Role | What they receive |
|---|---|---|
| Preemie Prep for Parents (P3) Outpatient Mobile Intervention | Experimental | The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants. Receives: Other: Preemie Prep for Parents (P3) Outpatient Mobile Intervention |
| ACOG links | Active comparator | Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists. Receives: Other: ACOG links |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Prematurity Knowledge Questionnaire
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items. Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.
Measured: Assessed at participant's 25th week of pregnancy.
Parent Prematurity Knowledge Questionnaire
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items. Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.
Measured: Assessed at participant's 30th week of pregnancy.
Parent Prematurity Knowledge Questionnaire
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.
Measured: Assessed at participant's 34th week of pregnancy.
Preparation for Decision Making Scale
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
Measured: Assessed at participant's 25th week of pregnancy.
Preparation for Decision Making Scale
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
Measured: Assessed at participant's 30th week of pregnancy.
Preparation for Decision Making Scale
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
Measured: Assessed at participant's 34th week of pregnancy.
Secondary outcomes (6)
Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Measured: Assessed at baseline
Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Measured: Assessed at participant's 25th week of pregnancy.
Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Measured: Assessed at participant's 30th week of pregnancy.
Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Measured: Assessed at participant's 34th week of pregnancy.
Decision Self-Efficacy
Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy.
Measured: Assessed at baseline
Decision Self-Efficacy
Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of decision self-efficacy.
Measured: Assessed at 34 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start3 Feb 2020
- Primary completion1 Sep 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mir A Basir, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093492
- Sponsor's protocol ID
- PRO00033902
- Other IDs
- R21HD092664
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2019
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basir MA, McDonnell SM, Brazauskas R, Kim UO, Ahamed SI, McIntosh JJ, Pizur-Barnekow K, Pitt MB, Kruper A, Leuthner SR, Flynn KE. Effect of fathers in Preemie Prep for Parents (P3) program on couple's preterm birth preparedness. Patient Educ Couns. 2025 Mar;132:108599. doi: 10.1016/j.pec.2024.108599. Epub 2024 Dec 4.
PubMed 39647248McDonnell SM, Flynn KE, McIntosh JJ, Brazauskas R, Kim UO, Ahamed SI, Basir MA. Video Education in Early Pregnancy and Parent Knowledge of Neonatal Resuscitation Options: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2344645. doi: 10.1001/jamanetworkopen.2023.44645.
PubMed 38010656Flynn KE, McDonnell SM, Brazauskas R, Ahamed SI, McIntosh JJ, Pitt MB, Pizur-Barnekow K, Kim UO, Kruper A, Leuthner SR, Basir MA. Smartphone-Based Video Antenatal Preterm Birth Education: The Preemie Prep for Parents Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 31;177(9):921-9. doi: 10.1001/jamapediatrics.2023.1586. Online ahead of print.
PubMed 37523163
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education
- ClinicalTrials.gov ID
- NCT04093492
- Acronym / sponsor ID
- PRO00033902
- Keywords
- gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.
Detailed description
This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making.
Participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age.
At study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preemie Prep for Parents (P3) Outpatient Mobile Intervention | Experimental | Other: Preemie Prep for Parents (P3) Outpatient Mobile InterventionThe P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants. |
| ACOG links | Active comparator | Other: ACOG linksParticipants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant woman or her partner
- At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications.
- Gestational age of 16-21 weeks at recruitment.
- Owns a smartphone.
- Able to speak English
Key exclusion criteria (1 listed)
- Pregnancies with known significant birth defects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preemie Prep for Parents (P3) Outpatient Mobile InterventionThe P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants. | Other | Preemie Prep for Parents (P3) Outpatient Mobile Intervention |
| ACOG linksParticipants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists. | Other | ACOG links |
Primary outcome
Parent Prematurity Knowledge Questionnaire
Time frame: Assessed at participant's 25th week of pregnancy.
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items. Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.
Parent Prematurity Knowledge Questionnaire
Time frame: Assessed at participant's 30th week of pregnancy.
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items. Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.
Parent Prematurity Knowledge Questionnaire
Time frame: Assessed at participant's 34th week of pregnancy.
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.
Preparation for Decision Making Scale
Time frame: Assessed at participant's 25th week of pregnancy.
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
Preparation for Decision Making Scale
Time frame: Assessed at participant's 30th week of pregnancy.
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
Preparation for Decision Making Scale
Time frame: Assessed at participant's 34th week of pregnancy.
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
6 secondary outcomes
Anxiety
Time frame: Assessed at baseline
Anxiety
Time frame: Assessed at participant's 25th week of pregnancy.
Anxiety
Time frame: Assessed at participant's 30th week of pregnancy.
Anxiety
Time frame: Assessed at participant's 34th week of pregnancy.
Decision Self-Efficacy
Time frame: Assessed at baseline
Decision Self-Efficacy
Time frame: Assessed at 34 weeks of pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39647248Basir MA, McDonnell SM, Brazauskas R, Kim UO, Ahamed SI, McIntosh JJ, Pizur-Barnekow K, Pitt MB, Kruper A, Leuthner SR, Flynn KE. Effect of fathers in Preemie Prep for Parents (P3) program on couple's preterm birth preparedness. Patient Educ Couns. 2025 Mar;132:108599. doi: 10.1016/j.pec.2024.108599. Epub 2024 Dec 4.
- Derived from this study: PubMed 38010656McDonnell SM, Flynn KE, McIntosh JJ, Brazauskas R, Kim UO, Ahamed SI, Basir MA. Video Education in Early Pregnancy and Parent Knowledge of Neonatal Resuscitation Options: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2344645. doi: 10.1001/jamanetworkopen.2023.44645.
- Derived from this study: PubMed 37523163Flynn KE, McDonnell SM, Brazauskas R, Ahamed SI, McIntosh JJ, Pitt MB, Pizur-Barnekow K, Kim UO, Kruper A, Leuthner SR, Basir MA. Smartphone-Based Video Antenatal Preterm Birth Education: The Preemie Prep for Parents Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 31;177(9):921-9. doi: 10.1001/jamapediatrics.2023.1586. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preemie Prep for Parents (P3) Outpatient Mobile Intervention and ACOG links in people with Premature Birth and Decision Making, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Prematurity Knowledge Questionnaire (time frame: Assessed at participant's 25th week of pregnancy.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093492, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.