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Clinical Trials/NCT04257552
NCT04257552CompletedNot Applicable

Care After Pregnancy Study (CAPS): Randomized Controlled Trial of Patient Engagement After Pregnancy

University of Pittsburgh1 site in 1 country128 target enrollmentStarted: February 3, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Locations
1
Primary Endpoint
Number of Participants Using a Non-barrier Method of Contraception

Study Overview

Brief Summary

The overarching hypothesis of our research agenda is that an intervention that engages economically disadvantaged women in personalized postpartum care will promote equality in maternal child health. As a first step to test our hypothesis the investigators propose the following aims:

Specific Aim 1: Measure the impact of Healthy Beyond Pregnancy on key components of postpartum care, including use of effective contraception at three and six months postpartum and breastfeeding duration at three and six months.

Specific Aim 2: Determine if Healthy Beyond Pregnancy improves adherence to health screening and linkage to follow-up care for women with cardio-metabolic complications of pregnancy.

Detailed Description

There are profound economic inequalities in a wide range of important maternal and child health outcomes ranging from neonatal death to maternal morbidity and mortality. The overarching scientific premise for our proposal is that these inequalities stem in part from poor engagement in postpartum care by economically disadvantaged women. The investigators hypothesize that an innovative intervention grounded in empirically derived tenets of behavioral economics that includes the critical components of the American College of Obstetricians and Gynecologists (ACOG) new vision for postpartum care will narrow gaps in important maternal child health outcomes.

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 untimed pregnancies and short duration of breastfeeding for the health of mothers, infants and children are well documented. In addition to significant health implications, these inequalities have important economic ramifications. The cost of births from unintended pregnancies in 2006 was estimated at $11 billion in maternity and infant care. This does not include cost of abortion care, lost productivity, and government assistance.

Providers have effective postpartum strategies to reduce the risk of poorly timed pregnancies and low breastfeeding rates.

Short interval or poorly timed pregnancies: Women have a range of effective contraceptive options, however, not initiating contraception postpartum remains common. The provision of long-acting reversible contraception (LARC) including intrauterine devices (IUDs) and hormonal implants has been shown to decrease short interval pregnancies and the associated risk of preterm birth. Importantly, given the array of contraceptive options available to women, it is important to make LARC accessible while empowering women to choose a method that is effective and acceptable to them. This highlights the need for solutions to engage women in patient centered comprehensive contraceptive decision-making in the postpartum period.

Short Breastfeeding Duration: A number of strategies have been shown to increase breastfeeding success. Most relevant to our proposal is that efforts to educate women about the benefits of breastfeeding, weekly text reminders in the immediate postpartum period, and access to a lactation consultant have all improved both duration and exclusivity of breastfeeding. Importantly, three recent trials demonstrated significant increases in exclusive breastfeeding from eight weeks to six months postpartum among women who received weekly-automated text message breastfeeding support. These interventions may be particularly relevant to our target population, as low-income, non-Hispanic Black women between 18-29 years send and receive text messages more frequently than any other demographic.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Investigator)

Masking Description

Investigators are unaware of study arm.

Eligibility Criteria

Ages
12 Years to 50 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Insured by a PA Medicaid insurance
  • •Pregnancy care in the Magee Womens Hospital Outpatient Clinic

Exclusion Criteria

  • •Delivery less than 24 weeks
  • •Fetal or neonatal demise
  • •Women who had a postpartum tubal ligation
  • •Women less than 18 year of age

Arms & Interventions

Attention Control Group

Active Comparator

If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.

Intervention: Attention Control (Other)

Pre-Scheduled Postpartum Visit:

Active Comparator

If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.

Intervention: Pre-Scheduled Postpartum Visit (Behavioral)

Healthy Beyond Pregnancy

Experimental

Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.

Intervention: Healthy Beyond Pregnancy (Behavioral)

Outcomes

Primary Outcomes

Number of Participants Using a Non-barrier Method of Contraception

Time Frame: 6 months after delivery

Effective contraception (non-barrier method)

Adherence of Postpartum Visit

Time Frame: 12 weeks after deliery

Attendance at postpartum visit (yes/no)

Number of Participants Using a Non-barrier Method of Contraception

Time Frame: 3 months after delivery

Effective contraception (non-barrier method)

Secondary Outcomes

  • The Number of Participants Who Given Their Infant Breast Milk(6 months after delivery)
  • The Number of Participants Who Given Their Infant Breast Milk(1 week after delivery)
  • The Number of Participants Who Given Their Infant Breast Milk(1 month after delivery)
  • The Number of Participants Who Given Their Infant Breast Milk(3 months after delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katherine Himes

Associate Professor of Medicine

University of Pittsburgh

Study Sites (1)

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