Postpartum HypertensionNCT03026686
Postpartum Readmission
An observational study of Postpartum Hypertension, run by St. Louis University.
Trial summary
This is a retrospective chart review of women who labored and delivered in a single health care center. From that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Postpartum Hypertension
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Sep 2017
- Phase
- Observational
- 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 14 to 55 years
- Women only
- Child, Adult
Study population: Women postpartum who are re-admitted for hypertension disorders
Who may be able to join
- Women who labored and delivered at a single hospital Readmitted (within 6 weeks post partum (PP) or less)to the hospital for hypertension disorder, with or without hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia (PreE), severe pre eclampsia (sPreE), HELLP ("HELLP" is an abbreviation of the three main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet count.).
- Controls Group with PreE, not readmitted or No PreE
Who cannot join
- Hospital readmission for other complications.
About this study
Official title: Postpartum Preeclampsia Readmission
This is a retrospective chart review of women who labored and delivered in a single health care center. From that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. The study will also look at "Controls," a group of women with similar risk factors but did not require readmission.
Read the detailed description
Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. There is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. Management before the onset of labor includes close monitoring of maternal and fetal status. Management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the ultimate treatment.
Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness
Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. During the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. This results in re-admission to the hospital for some women. The investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.
- Conditions
- Postpartum Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| readmit | women who were re-admitted in the post partum period for a hypertensive disorder | |
| Controls | women with similar risk factors but did not require readmission |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypertension
compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Insufficient personel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Goldkamp, MD, St. Louis University
- Investigators
- Jennifer Goldkamp, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026686
- Sponsor's protocol ID
- 24998
- Status last verified
- Oct 2017
- First submitted
- 18 Jan 2017
- Last updated
- 11 Oct 2017
- 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 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Preeclampsia Readmission
- ClinicalTrials.gov ID
- NCT03026686
- Acronym / sponsor ID
- 24998
- Conditions
- Postpartum Hypertension
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient personel
- Enrolment
- 335 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
This is a retrospective chart review of women who labored and delivered in a single health care center. From that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. The study will also look at "Controls," a group of women with similar risk factors but did not require readmission.
Detailed description
Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. There is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. Management before the onset of labor includes close monitoring of maternal and fetal status. Management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the ultimate treatment.
Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness
Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. During the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. This results in re-admission to the hospital for some women. The investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| readmit | – | –women who were re-admitted in the post partum period for a hypertensive disorder |
| Controls | – | –women with similar risk factors but did not require readmission |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Women postpartum who are re-admitted for hypertension disorders
Key inclusion criteria (2 listed)
- Women who labored and delivered at a single hospital Readmitted (within 6 weeks post partum (PP) or less)to the hospital for hypertension disorder, with or without hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia (PreE), severe pre eclampsia (sPreE), HELLP ("HELLP" is an abbreviation of the three main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet count.).
- Controls Group with PreE, not readmitted or No PreE
Key exclusion criteria (1 listed)
- Hospital readmission for other complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hypertension
Time frame: 1 year
compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.
Results and safety
The study was stopped early (reason given: Insufficient personel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- 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.
Jennifer Goldkamp, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hypertension, run by St. Louis University.
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 2 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: stopped early, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Insufficient personel). Results are not available in the source record.
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?
hypertension (time frame: 1 year). 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 11 Oct 2017.