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Postpartum CareNCT03296774

Healthy Beyond Pregnancy: Improving Postpartum Care

A study testing Healthy Beyond Pregnancy in people with Postpartum Care, run by University of Pittsburgh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT03296774
Study groupRoleWhat they receive
Usual CarePlacebo comparatorUsual postpartum care
Receives: Behavioral: Usual Care
Healthy Beyond PregnancyExperimentalWeb-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.

  1. 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)
  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.

  1. First posted28 Sep 2017
  2. Study start1 Nov 2016
  3. Primary completion15 Feb 2017
  4. Study completion30 May 2017

Resources

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)
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

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.

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