ClinicalTrials.gg
CompletedNCT05399784Updated Aug 2, 2023

Postpartum Visit Timing and the Effect on Visit Attendance

An interventional study of Early postpartum visit and Standard postpartum visit in Postpartum Disorder, Postpartum Depression and Postpartum Weight Retention, sponsored by Women and Infants Hospital of Rhode Island. Completed at 1 site in United States. Open to female participants aged 13 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-02.

Primary conditionDepression, PostpartumRegistry: Puerperal DisordersReclassifiedWhy we changed it
Registry
Puerperal Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression, Postpartum
Why
  1. The study's listed conditions name Depression, Postpartum, a narrower term within Puerperal Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
13 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Postpartum Disorder
  • Postpartum Depression
  • Postpartum Weight Retention
  • Breastfeeding
  • Satisfaction, Patient
  • Trust
03

In context

Depression, Postpartum Reclassified

569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.

This study's enrollment of 162 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.

Compared within Depression, Postpartum, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Puerperal Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
13 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

High risk pregnancy defined as one or more of the following:

  • chronic hypertension
  • gestational hypertension
  • preeclampsia
  • eclampsia
  • third degree perineal laceration
  • fourth degree perineal laceration
  • blood product transfusion
  • intensive care unit admission
  • who were prescribed anxiolytic or antidepressant medications in the antepartum period
05

Study design

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

Study arms

  • Experimental
    Early & Often Postpartum Care

    Visit at 2-3 and 6 weeks postpartum.

    Behavioral: Early postpartum visit · Behavioral: Standard postpartum visit

  • Placebo comparator
    Standard Postpartum Care

    Visit at 6 weeks postpartum.

    Behavioral: Standard postpartum visit

Interventions

  • BehavioralEarly postpartum visit

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

  • BehavioralStandard postpartum visit

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 3 months

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 3 months

07

Study locations

1 site
  • Women & Infants Hospital
    Providence, Rhode Island 02905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05399784
Lead sponsor
Women and Infants Hospital of Rhode Island
Responsible party
Sponsor
First posted
Jun 1, 2022
Start date
Feb 1, 2021
Primary completion
Apr 1, 2023
Completion
Jun 1, 2023
Last update
Aug 2, 2023

Study contacts

Martha B Kole-White, MD
principal investigator · Women & Infants Hospital

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 Jul 2023. You cannot join it, but the record below documents what was studied.

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