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.
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
- Conditions the study is for
- Postpartum Disorder, Postpartum Depression, Postpartum Weight Retention
- What is being tested?
- Early postpartum visit and Standard postpartum visit
- Type of treatment
- Lifestyle or therapy programme
- 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
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- 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
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.
- Conditions
- Postpartum Disorder, Postpartum Depression, Postpartum Weight Retention, Breastfeeding, Satisfaction, Patient, Trust
- 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 group | Role | What they receive |
|---|---|---|
| Early & Often Postpartum Care | Experimental | Visit at 2-3 and 6 weeks postpartum. Receives: Behavioral: Early postpartum visit; Behavioral: Standard postpartum visit |
| Standard Postpartum Care | Placebo comparator | Visit 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.
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)
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
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
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
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.
- First posted1 Jun 2022
- Study start1 Feb 2021
- Primary completion1 Apr 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha B Kole-White, MD, Principal investigator, Women & Infants Hospital
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