Preterm BirthNCT04663607
Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth
A study testing Use of PretermConnect App in people with Preterm Birth, run by Stanford University at 2 sites in United States.
Trial summary
Preterm births are defined as delivery prior to 37 weeks gestation and account for 35% of infant deaths in the first year of life. Early preterm birth are deliveries prior to 32 weeks gestation and account for more than 70% of neonatal deaths and 36.1% of overall infant mortality. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Use of PretermConnect App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2021to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals with a mobile phone capable of downloading apps from the Apple App Store or Google Play.
- Participants must consent to the study.
- Women whose child is in the neonatal intensive care unit/nursery because the infant was born preterm.
- Women 16-50 years of age
- Women who can read, write and understand English
- Site-specific additional recruitment criteria
- UPMC Children's Hospital of Pittsburgh: Mothers whose babies have been in the neonatal intensive care unit for more than one month.
- UPMC Magee-Womens Hospital: Mothers who have had a preterm baby of <36 weeks.
Who cannot join
- For this initial study, those who do not have a mobile phone will be excluded. (This exclusion will not affect the inclusion of minorities as minorities Internet use via mobile platforms is equal to or greater than whites; hence we are not excluding minorities, based on the PEW Research Center study (PEW Internet Spring Tracking Survey, April 17-May 19, 2013)).
- Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Randomized Controlled Trial Using Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth
Preterm births are defined as delivery prior to 37 weeks gestation and account for 35% of infant deaths in the first year of life. Early preterm birth are deliveries prior to 32 weeks gestation and account for more than 70% of neonatal deaths and 36.1% of overall infant mortality. Women who have delivered a preterm infant and who have a short pregnancy interval (time between giving birth and subsequent conception) have an increased risk of preterm birth in subsequent pregnancies. The investigators hope to understand if a mobile health strategy can be used to reduce spontaneous preterm births via improved patient engagement, care coordination, and adherence to recommended care vs a traditional paper-based health strategy.
Read the detailed description
The investigators hope to learn how to engage pregnant women at risk for preterm births and reduce the incidence of preterm births through this study. The goal of this study is to reduce the risk of recurrent preterm births for the participating mothers and healthy development of their infants. The investigators hope that this study will accomplish the following for the mothers: Utilize technology to strengthen knowledge of healthy behaviors; Improve adherence to both behavioral and medical interventions that specifically aimed at reducing the risk of spontaneous recurrent preterm births; Develop a platform that can capture participant behavior regarding the participant's lifestyle, environment, social factors, and personal health status; Allow participants to be co-creators of content, thus creating a support network. The investigators hope to achieve improvements in the following primary outcome: Inter-pregnancy interval and the following secondary outcomes: postpartum depression, infant-mother bonding and breast milk feeding between the control and the intervention groups. Ultimately, the investigators hope improvements in these outcomes will improve secondary prevention of preterm births and ultimately reduce infant mortality.
Additionally, PretermConnect will monitor mothers on their social circumstances, such as housing and food insecurity, family employment status, and perceived importance of recommended care for the baby's and the participant's own health.
The investigators also want to observe if a mobile-delivered health management approach can be more effective than a traditional paper-based health management plan in reducing the incidence of subsequent preterm births amongst individuals who have already had at least one preterm birth.
- Conditions
- Preterm Birth
- Being tested
- Use of PretermConnect App
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of PretermConnect AppBehavioural
Participants will receive health education via a mobile app, PretermConnect, in addition to the standard of care, and complete additional surveys on the social determinants of health
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive paper-based health education as part of standard of care |
| PretermConnect App | Experimental | Participants will receive health education via a mobile app, PretermConnect Receives: Behavioral: Use of PretermConnect App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpregnancy interval
Time interval from most recent birth to next conception
Measured: 12-months
Secondary outcomes (3)
Breastmilk feeding
Number of participants feeding baby breastmilk by bottle or breast
Measured: 12-months
Postpartum depression
Number of participants that screen for postpartum depression
Measured: 12-months
Mother-infant bonding
Score on mother-infant bonding questionnaire (score range is 10-50; higher scores indicate higher level of bonding)
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start7 Oct 2021
- Primary completion22 Jun 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Jason Wang, Stanford University
- Investigators
- C. Jason Wang, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663607
- Sponsor's protocol ID
- 54976
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2020
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Using Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth
- ClinicalTrials.gov ID
- NCT04663607
- Acronym / sponsor ID
- 54976
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Children's Hospital of Philadelphia
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm births are defined as delivery prior to 37 weeks gestation and account for 35% of infant deaths in the first year of life. Early preterm birth are deliveries prior to 32 weeks gestation and account for more than 70% of neonatal deaths and 36.1% of overall infant mortality. Women who have delivered a preterm infant and who have a short pregnancy interval (time between giving birth and subsequent conception) have an increased risk of preterm birth in subsequent pregnancies. The investigators hope to understand if a mobile health strategy can be used to reduce spontaneous preterm births via improved patient engagement, care coordination, and adherence to recommended care vs a traditional paper-based health strategy.
Detailed description
The investigators hope to learn how to engage pregnant women at risk for preterm births and reduce the incidence of preterm births through this study. The goal of this study is to reduce the risk of recurrent preterm births for the participating mothers and healthy development of their infants. The investigators hope that this study will accomplish the following for the mothers: Utilize technology to strengthen knowledge of healthy behaviors; Improve adherence to both behavioral and medical interventions that specifically aimed at reducing the risk of spontaneous recurrent preterm births; Develop a platform that can capture participant behavior regarding the participant's lifestyle, environment, social factors, and personal health status; Allow participants to be co-creators of content, thus creating a support network. The investigators hope to achieve improvements in the following primary outcome: Inter-pregnancy interval and the following secondary outcomes: postpartum depression, infant-mother bonding and breast milk feeding between the control and the intervention groups. Ultimately, the investigators hope improvements in these outcomes will improve secondary prevention of preterm births and ultimately reduce infant mortality.
Additionally, PretermConnect will monitor mothers on their social circumstances, such as housing and food insecurity, family employment status, and perceived importance of recommended care for the baby's and the participant's own health.
The investigators also want to observe if a mobile-delivered health management approach can be more effective than a traditional paper-based health management plan in reducing the incidence of subsequent preterm births amongst individuals who have already had at least one preterm birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive paper-based health education as part of standard of care |
| PretermConnect App | Experimental | Behavioral: Use of PretermConnect AppParticipants will receive health education via a mobile app, PretermConnect |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Individuals with a mobile phone capable of downloading apps from the Apple App Store or Google Play.
- Participants must consent to the study.
- Women whose child is in the neonatal intensive care unit/nursery because the infant was born preterm.
- Women 16-50 years of age
- Women who can read, write and understand English
Key exclusion criteria (2 listed)
- For this initial study, those who do not have a mobile phone will be excluded. (This exclusion will not affect the inclusion of minorities as minorities Internet use via mobile platforms is equal to or greater than whites; hence we are not excluding minorities, based on the PEW Research Center study (PEW Internet Spring Tracking Survey, April 17-May 19, 2013)).
- Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.
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 |
|---|---|---|
| Use of PretermConnect AppParticipants will receive health education via a mobile app, PretermConnect, in addition to the standard of care, and complete additional surveys on the social determinants of health | Behavioural | PretermConnect App |
Primary outcome
Interpregnancy interval
Time frame: 12-months
Time interval from most recent birth to next conception
3 secondary outcomes
Breastmilk feeding
Time frame: 12-months
Postpartum depression
Time frame: 12-months
Mother-infant bonding
Time frame: 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- 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.
C. Jason Wang, MD, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of PretermConnect App in people with Preterm Birth, run by Stanford University at 2 sites 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 8 inclusion and 2 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interpregnancy interval (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.