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Postpartum DisorderNCT05399784

Postpartum Visit Timing and the Effect on Visit Attendance

A study testing Early postpartum visit and Standard postpartum visit in people with Postpartum Disorder and Postpartum Depression, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

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

The objective of this study is to assess if the addition of an early postpartum visit improves attendance at postpartum visits. We seek to evaluate if an additional early postpartum visit improves patient education, satisfaction, or trust in the clinicians during the postpartum period; all of which may ultimately… Read more about this study

Who is it for?
Ages 13 to 50 years, women only
What is being tested?
Early postpartum visit and Standard postpartum visit
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 siteUnited States
Study dates
1 Feb 2021to 1 Jun 2023
Phase
Interventional

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 13 to 50 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • age 13 to 50 years old
  • literacy in English or Spanish
  • receipt of prenatal care at the Obstetrics and Gynecology Care Center of Women \& Infants Hospital
  • delivery at Women \& Infants Hospital during the study time period

Who cannot join

  • High risk pregnancy defined as one or more of the following:
  • chronic hypertension
  • gestational hypertension
  • preeclampsia
  • eclampsia
  • third degree perineal laceration
Show all 10Show fewer
  • fourth degree perineal laceration
  • blood product transfusion
  • intensive care unit admission
  • who were prescribed anxiolytic or antidepressant medications in the antepartum period

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Women & Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

The objective of this study is to assess if the addition of an early postpartum visit improves attendance at postpartum visits. We seek to evaluate if an additional early postpartum visit improves patient education, satisfaction, or trust in the clinicians during the postpartum period; all of which may ultimately facilitate improved outcomes. Additionally, we seek to explore patient preferences for postpartum care delivery.

Read the detailed description

Maternal mortality in the United States is currently at a record high of 17 deaths per 100,000 live births and the majority of pregnancy related deaths occur in the postpartum period due to complications from chronic disease exacerbation, pregnancy-related hypertension, or psychiatric conditions that lead to suicide. Optimal postpartum care would reduce mortality risk, but numerous studies have demonstrated current care is inadequate. Up to 40% of women do not attend their postpartum visit at 4-6 weeks after delivery and the 15-minute visit is too short to achieve the comprehensive goals that the American College of Obstetricians and Gynecologists (ACOG) sets for this visit: a full assessment of physical, social, and psychological well-being. In addressing the current gap between optimal and actual care, ACOG recently recommended that practitioners shift from the standard, single six-week postpartum visit to two postpartum visits, the first within three weeks of delivery. While this change is intended to address current sub-optimal outcomes, the effects of this change are entirely unknown.

The long term goal of our program is to improve postpartum care for women in Rhode Island. The primary objective of this project is to determine if the ACOG proposed additional postpartum visit within three weeks of delivery improves attendance to postpartum appointments compared to routine postpartum care. Additionally, we intend to examine whether having two scheduled postpartum visits (one within three weeks and the other at the standard 4-6 week postpartum time point) which we describe as "early and often" postpartum care-improves patient knowledge, satisfaction and trust in clinicians compared to routine care as well as explore patient preferences for postpartum care. Our central hypothesis is that early and often postpartum care will lead to improved patient visit attendance compared to routine care.

Being tested
Early postpartum visit, Standard postpartum visit
Medical subject headings
Puerperal Disorders, Depression, Postpartum, Gestational Weight Gain, Breast Feeding, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early postpartum visitBehavioural

    The early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum.

  • Standard postpartum visitBehavioural

    The standard postpartum visit will occur at 35 to 56 days postpartum.

Study groups in NCT05399784
Study groupRoleWhat they receive
Early & Often Postpartum CareExperimentalVisit at 2-3 and 6 weeks postpartum.
Receives: Behavioral: Early postpartum visit; Behavioral: Standard postpartum visit
Standard Postpartum CarePlacebo comparatorVisit at 6 weeks postpartum.
Receives: Behavioral: Standard postpartum visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of postpartum visits attended

    The number of times a patient attends a postpartum visit in the first 12 weeks postpartum will be counted

    Measured: 3 months

Secondary outcomes (4)
  1. Number of recommended items covered during postpartum care

    Patients will complete a survey (created for this study) and identify how many key postpartum items were discussed during their postpartum care.

    Measured: 3 months

  2. Trust in physician scale

    The Trust in Physicians scale is a reliable and valid measure of a patients trust in their clinician and has been shown to be distinct from patient satisfaction

    Measured: 3 months

  3. Short Assessment of Patient Satisfaction

    The Short Assessment of Patient Satisfaction (SAPS) is a short, reliable, valid, seven item scale to assess patients satisfaction with medical treatment and care

    Measured: 3 months

  4. Number of emergency room visits

    Emergency room utilization will be determined via the electronic medical record. The number of visits in the first 3 months postpartum will be recorded.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start1 Feb 2021
  3. Primary completion1 Apr 2023
  4. Study completion1 Jun 2023

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05399784
Sponsor's protocol ID
Kole_ConstanceHowesGrant_2020
Status last verified
Jul 2023
First submitted
20 Oct 2021
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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