CClinicalTrials.gg
CompletedNCT03296774Updated Nov 18, 2023

Healthy Beyond Pregnancy: Improving Postpartum Care

An interventional study of Healthy Beyond Pregnancy and Usual Care in Postpartum Care, sponsored by University of Pittsburgh. Completed. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Postpartum Care
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Delivery less than 24 weeks, fetal or neonatal death, non-English speaking, no text-enabled phone
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Placebo comparator
    Usual Care

    Usual postpartum care

    Behavioral: Usual Care

  • Experimental
    Healthy Beyond Pregnancy

    Web-based program for postpartum care and education and scheduling. Incentive for committing and returning for postpartum care.

    Behavioral: Healthy Beyond Pregnancy

Interventions

  • BehavioralHealthy Beyond Pregnancy

    Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.

  • BehavioralUsual Care
05

What researchers measure

Primary outcomes

  1. Number of eligible participants who consent and complete study intervention

    Assess the feasibility of a larger randomized controlled trial

    Time frame: 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

    Time frame: 21-56 days after delivery

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03296774
Lead sponsor
University of Pittsburgh
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Nov 1, 2016
Primary completion
Feb 15, 2017
Completion
May 30, 2017
Last update
Nov 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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