Hypertension in PregnancyNCT06054841
Reshaping Postpartum Follow-up
A study testing Postpartum follow up card in people with Hypertension in Pregnancy and Gestational Diabetes, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy, Gestational Diabetes, Cervical Dysplasia
- What is being tested?
- Postpartum follow up card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 1 Mar 2025
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects >=18 years of age
- Ability to read English or Spanish
- Delivered via vaginal delivery or c-section within the past 48 hours
- Able to consent for themselves
Who cannot join
- Received antepartum care at a facility outside of the Medstar system or plans to continue care with a facility outside of the Medstar system
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Reshaping Postpartum Follow-up in Women With High Risk Pregnancies
The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge.
The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.
- Being tested
- Postpartum follow up card, Control
- Keywords
- Postpartum followup, hypertensive disorders of pregnancy, eclampsia, pre-eclampsia, pap smear, gestational diabetes
- Medical subject headings
- Hypertension, Pregnancy-Induced, Diabetes, Gestational, Uterine Cervical Dysplasia, Eclampsia, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum follow up cardBehavioural
The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. The back of the card will list relevant phone numbers to assist patients with scheduling.
ControlOther
No deviation from standard discharge education
| Study group | Role | What they receive |
|---|---|---|
| Follow up cards | Experimental | Subjects will receive a personalized postpartum health card with recommendations for follow up based on their comorbid conditions in pregnancy. They will receive education about these comorbid conditions when they receive their cards. Receives: Behavioral: Postpartum follow up card |
| Standard education | Placebo comparator | Subjects will receive standard postpartum education as it is routinely performed by nurses prior to discharge. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure check
Rate of attendance at a blood pressure check one week postpartum
Measured: 6 months
Two hour glucose tolerance test
Rate of completion of two hour glucose tolerance test at six weeks postpartum
Measured: 6 months
Secondary outcomes (2)
Cervical cancer screening
Rate of completion of postpartum pap smear or colposcopy as indication
Measured: 6 months
Primary care
Rate of attendance at visit with primary care provider for annual exam
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start22 May 2023
- Primary completion1 Aug 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies 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
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054841
- Sponsor's protocol ID
- STUDY00006037
- Status last verified
- Jun 2025
- First submitted
- 22 May 2023
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reshaping Postpartum Follow-up in Women With High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT06054841
- Acronym / sponsor ID
- STUDY00006037
- Keywords
- Postpartum followup, hypertensive disorders of pregnancy, eclampsia, pre-eclampsia, pap smear, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 26 Sep 2023 (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 aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge.
The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow up cards | Experimental | Behavioral: Postpartum follow up cardSubjects will receive a personalized postpartum health card with recommendations for follow up based on their comorbid conditions in pregnancy. They will receive education about these comorbid conditions when they receive their cards. |
| Standard education | Placebo comparator | Other: ControlSubjects will receive standard postpartum education as it is routinely performed by nurses prior to discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects >=18 years of age
- Ability to read English or Spanish
- Delivered via vaginal delivery or c-section within the past 48 hours
- Able to consent for themselves
Key exclusion criteria (1 listed)
- Received antepartum care at a facility outside of the Medstar system or plans to continue care with a facility outside of the Medstar system
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 |
|---|---|---|
| Postpartum follow up cardThe intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. The back of the card will list relevant phone numbers to assist patients with scheduling. | Behavioural | Follow up cards |
| ControlNo deviation from standard discharge education | Other | Standard education |
Primary outcome
Blood pressure check
Time frame: 6 months
Rate of attendance at a blood pressure check one week postpartum
Two hour glucose tolerance test
Time frame: 6 months
Rate of completion of two hour glucose tolerance test at six weeks postpartum
2 secondary outcomes
Cervical cancer screening
Time frame: 6 months
Primary care
Time frame: 6 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 29 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum follow up card in people with Hypertension in Pregnancy and Gestational Diabetes, run by Medstar Health Research Institute 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 1 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 29 Jun 2025. 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?
Blood pressure check (time frame: 6 months). The study lists 2 primary outcomes in all. 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 29 Jun 2025.