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
- Are there results?
- None posted in the registry
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
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Visit Timing and the Effect on Visit Attendance
- ClinicalTrials.gov ID
- NCT05399784
- Acronym / sponsor ID
- Kole_ConstanceHowesGrant_2020
- Conditions
- Postpartum Disorder, Postpartum Depression, Postpartum Weight Retention, Breastfeeding, Satisfaction, Patient, Trust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early & Often Postpartum Care | Experimental | Behavioral: Early postpartum visit, Behavioral: Standard postpartum visitVisit at 2-3 and 6 weeks postpartum. |
| Standard Postpartum Care | Placebo comparator | Behavioral: Standard postpartum visitVisit at 6 weeks postpartum. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- chronic hypertension
- gestational hypertension
- preeclampsia
- eclampsia
- third degree perineal laceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early postpartum visitThe early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum. | Behavioural | Early & Often Postpartum Care |
| Standard postpartum visitThe standard postpartum visit will occur at 35 to 56 days postpartum. | Behavioural | Early & Often Postpartum Care, Standard Postpartum Care |
Primary outcome
Number of postpartum visits attended
Time frame: 3 months
The number of times a patient attends a postpartum visit in the first 12 weeks postpartum will be counted
4 secondary outcomes
Number of recommended items covered during postpartum care
Time frame: 3 months
Trust in physician scale
Time frame: 3 months
Short Assessment of Patient Satisfaction
Time frame: 3 months
Number of emergency room visits
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha B Kole-White, MD principal investigator
Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of postpartum visits attended (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.