Postpartum CareNCT03296774
Healthy Beyond Pregnancy: Improving Postpartum Care
A study testing Healthy Beyond Pregnancy in people with Postpartum Care, run by University of Pittsburgh.
Trial summary
Minority women and women of lower socioeconomic status are at significantly increased risk of unintended pregnancies, short inter-pregnancy interval, and short duration of breastfeeding. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Care
- What is being tested?
- Healthy Beyond Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 30 May 2017
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum 6-72 hours from delivery, aged 18-50, receipt of prenatal care through the Magee-Womens Hospital outpatient clinic and UPMC for You Medicaid insurance.
Who cannot join
- Delivery less than 24 weeks, fetal or neonatal death, non-English speaking, no text-enabled phone
About this study
Official title: Healthy Beyond Pregnancy: A Pilot Usability and Feasibility Trial
Minority women and women of lower socioeconomic status are at significantly increased risk of unintended pregnancies, short inter-pregnancy interval, and short duration of breastfeeding. The consequences of poorly timed pregnancies and short duration of breastfeeding for the health of mothers, infants and children are well documented.
To decrease rates of poorly timed pregnancies, increase breastfeeding duration and address other postpartum concerns women must be engaged in their postpartum care outside of the traditional postpartum visit. In addition to contraceptive counseling and breastfeeding support, providers discuss a number of important maternal and child health issues at the postpartum visit. These include (1) screening and referral for postpartum mood disorders (2) screening for cardiometabolic consequences of pregnancy complications, (3) discussing inter-conception care and (4) connecting women with a primary care provider. Thus, as recommended by numerous professional societies, the standard postpartum visit at 4 to 6 weeks after delivery has considerable value to women's postpartum care.
Read more
Attendance rates for the postpartum visit are markedly lower for women with limited resources contributing to racial and economic health disparities. Despite receiving excellent prenatal care, only 40% of the economically disadvantaged women who receive prenatal care at the Magee outpatient clinic return for their postpartum visit. These parallel national trends, where 60% of women with Medicaid insurance return for a postpartum checkup compared with over 82% of women with private insurance. Medicaid programs serve pregnant women who are particularly vulnerable to poor health outcomes and thus this gap is critical. Additionally, minority women disproportionally receive Medicaid and thus interventions that focus on Medicaid recipients have the potential to address racial as well as economic disparities. These data demonstrate that the current care model does not engage all women to make good health care decision postpartum and is disproportionately failing our most vulnerable moms and babies.
Empirically derived concepts from behavioral economics can be leveraged to design interventions that support participants to make better health decisions and may be particularly useful for postpartum care.
The feasibility trial will focus on four tenants of behavioral economics-bounded rationality (information overload), status quo bias (lack of self-control), hovering (limited attention), and framed incentives-- that have been successfully used to tackle stubborn health problems such as smoking and obesity. Importantly, unlike tobacco cessation or weight loss, many aspects of postpartum care such as compliance with the visit or uptake of LARC, do not require on-going action on part of the patient and thus may be particularly amenable to the lessons of behavioral economics.
Specific Aim 1: To conduct a pilot trial evaluating the feasibility and acceptability of a future randomized trial to determine the efficacy of Healthy Beyond Pregnancy on adherence with the postpartum visit.
Specific Aim 2: To determine the impact of Healthy Beyond Pregnancy on adherence with the postpartum visit.
- Conditions
- Postpartum Care
- Being tested
- Healthy Beyond Pregnancy, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Beyond PregnancyBehavioural
Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.
Usual CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Usual postpartum care Receives: Behavioral: Usual Care |
| Healthy Beyond Pregnancy | Experimental | Web-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care. Receives: Behavioral: Healthy Beyond Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible participants who consent and complete study intervention
Assess the feasibility of a larger randomized controlled trial
Measured: 1-4 days postpartum
Secondary outcomes (1)
Adherence with postpartum visit- number of participants who return for postpartum visit.
Did participant come for postpartum visit
Measured: 21-56 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Nov 2016
- Primary completion15 Feb 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum CareStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296774
- Sponsor's protocol ID
- PRO16090292
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Himes KP, Donovan H, Wang S, Weaver C, Grove JR, Facco FL. Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial. JMIR Hum Factors. 2017 Oct 10;4(4):e26. doi: 10.2196/humanfactors.7964.
PubMed 29017990
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Beyond Pregnancy: A Pilot Usability and Feasibility Trial
- ClinicalTrials.gov ID
- NCT03296774
- Acronym / sponsor ID
- PRO16090292
- Conditions
- Postpartum Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 28 Sep 2017 (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.
Minority women and women of lower socioeconomic status are at significantly increased risk of unintended pregnancies, short inter-pregnancy interval, and short duration of breastfeeding. The consequences of poorly timed pregnancies and short duration of breastfeeding for the health of mothers, infants and children are well documented.
To decrease rates of poorly timed pregnancies, increase breastfeeding duration and address other postpartum concerns women must be engaged in their postpartum care outside of the traditional postpartum visit. In addition to contraceptive counseling and breastfeeding support, providers discuss a number of important maternal and child health issues at the postpartum visit. These include (1) screening and referral for postpartum mood disorders (2) screening for cardiometabolic consequences of pregnancy complications, (3) discussing inter-conception care and (4) connecting women with a primary care provider. Thus, as recommended by numerous professional societies, the standard postpartum visit at 4 to 6 weeks after delivery has considerable value to women's postpartum care.
Attendance rates for the postpartum visit are markedly lower for women with limited resources contributing to racial and economic health disparities. Despite receiving excellent prenatal care, only 40% of the economically disadvantaged women who receive prenatal care at the Magee outpatient clinic return for their postpartum visit. These parallel national trends, where 60% of women with Medicaid insurance return for a postpartum checkup compared with over 82% of women with private insurance. Medicaid programs serve pregnant women who are particularly vulnerable to poor health outcomes and thus this gap is critical. Additionally, minority women disproportionally receive Medicaid and thus interventions that focus on Medicaid recipients have the potential to address racial as well as economic disparities. These data demonstrate that the current care model does not engage all women to make good health care decision postpartum and is disproportionately failing our most vulnerable moms and babies.
Empirically derived concepts from behavioral economics can be leveraged to design interventions that support participants to make better health decisions and may be particularly useful for postpartum care.
The feasibility trial will focus on four tenants of behavioral economics-bounded rationality (information overload), status quo bias (lack of self-control), hovering (limited attention), and framed incentives-- that have been successfully used to tackle stubborn health problems such as smoking and obesity. Importantly, unlike tobacco cessation or weight loss, many aspects of postpartum care such as compliance with the visit or uptake of LARC, do not require on-going action on part of the patient and thus may be particularly amenable to the lessons of behavioral economics.
Specific Aim 1: To conduct a pilot trial evaluating the feasibility and acceptability of a future randomized trial to determine the efficacy of Healthy Beyond Pregnancy on adherence with the postpartum visit.
Specific Aim 2: To determine the impact of Healthy Beyond Pregnancy on adherence with the postpartum visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: Usual CareUsual postpartum care |
| Healthy Beyond Pregnancy | Experimental | Behavioral: Healthy Beyond PregnancyWeb-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Postpartum 6-72 hours from delivery, aged 18-50, receipt of prenatal care through the Magee-Womens Hospital outpatient clinic and UPMC for You Medicaid insurance.
Key exclusion criteria (1 listed)
- Delivery less than 24 weeks, fetal or neonatal death, non-English speaking, no text-enabled phone
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 |
|---|---|---|
| Healthy Beyond PregnancyWeb-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care. | Behavioural | Healthy Beyond Pregnancy |
| Usual Care | Behavioural | Usual Care |
Primary outcome
Number of eligible participants who consent and complete study intervention
Time frame: 1-4 days postpartum
Assess the feasibility of a larger randomized controlled trial
1 secondary outcome
Adherence with postpartum visit- number of participants who return for postpartum visit.
Time frame: 21-56 days after delivery
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 18 Nov 2023.
- Derived from this study: PubMed 29017990Himes KP, Donovan H, Wang S, Weaver C, Grove JR, Facco FL. Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial. JMIR Hum Factors. 2017 Oct 10;4(4):e26. doi: 10.2196/humanfactors.7964.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Beyond Pregnancy in people with Postpartum Care, run by University of Pittsburgh.
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 1 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Number of eligible participants who consent and complete study intervention (time frame: 1-4 days postpartum). 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 NCT03296774, which also lists 1 linked publication.
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 18 Nov 2023.