PreeclampsiaNCT00789919
Mild Preeclampsia Near Term: Deliver or Deliberate?
A study testing Delivery of infant in people with Preeclampsia, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Delivery of infant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jul 2008
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mild Preeclampsia equal to or greater than 34 weeks' and less that 38 weeks' gestation singleton gestation no maternal or fetal contraindications to conservative management
Who cannot join
- Non-gestational diabetes Chronic hypertension Severe preeclampsia Non-reassuring fetal assessment intrauterine growth restriction fetal anomalies multiple gestation premature preterm rupture of membranes placenta previa unexplained vaginal bleeding antihypertensive use current gestation poor dating criteria contraindication to conservative management active labor at admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Winfred L Wiser Hospital for Women and Infants
Jackson, Mississippi, 39216
About this study
Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops disease progression and recovery can begin. Patients with mild preeclampsia between 34-38 weeks' gestation usually are hospitalized for evaluation and close monitoring of signs, symptoms, and certain laboratory studies as reflectors of disease status. As inpatients mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34 weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when during the third trimester that delivery should be accomplished for maximal maternal safety and minimal fetal risk. In this research project, we will identify patients who are at least 34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial, we will randomize participants to either be delivered immediately or treated with observation and maternal-fetal surveillance in hospital as described previously with delivery at 38 weeks. There will be 110 participants enrolled in each arm of the study for a total of 220 patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal and fetal outcomes including cost comparisons for the care of both mother and fetus in the two groups of randomized patients. The findings should impact care of the pregnant patient with mild preeclampsia in the third trimester with regard to how early and how late in gestation that delivery should be accomplished for optimal maternal and perinatal benefit.
- Conditions
- Preeclampsia
- Being tested
- Delivery of infant
- Keywords
- Mild Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of infantProcedure or surgery
Vaginal delivery or cesarean section, whichever is indicated
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Study participants (those diagnosed with mild preeclampsia) are admitted to hospital for standard inpatient management of their disease. |
| 2 | Experimental | Study participants (those diagnosed with mild preeclampsia) are admitted to hospital and their infant is delivered as soon as possible after 34 weeks gestation. As there is no determined optimal time of delivery in these patients, delivery is the intervention. Receives: Procedure: Delivery of infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to severe preeclampsia in the control group necessitating delivery of the infant.
Measured: End of study
Secondary outcomes (2)
Maternal morbidity
Measured: End of study
Fetal morbidity and mortality
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startMar 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Y Owens, M.D., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789919
- Sponsor's protocol ID
- 2001-1114
- Status last verified
- Nov 2008
- First submitted
- 12 Nov 2008
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Preeclampsia Near Term: Deliver or Deliberate?
- ClinicalTrials.gov ID
- NCT00789919
- Acronym / sponsor ID
- 2001-1114
- Conditions
- Preeclampsia
- Keywords
- Mild Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Nov 2008 (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.
Preeclampsia with new-onset hypertension and proteinuria is a pregnancy-specific disease that affects 5-7% of gestations usually after the 20th week. Most cases are mild, but severe cases exhibit multiple abnormalities in blood and maternal organ systems. Severe forms of preeclampsia/eclampsia are a major contributor to maternal death in the world. Delivery stops disease progression and recovery can begin. Patients with mild preeclampsia between 34-38 weeks' gestation usually are hospitalized for evaluation and close monitoring of signs, symptoms, and certain laboratory studies as reflectors of disease status. As inpatients mothers are monitored frequently for evidence of maternal or fetal compromise until 38 weeks gestation when delivery is accomplished. If a patient with mild preeclampsia labors after 34 weeks, no attempt is made to stop labor and delivery is undertaken. It remains unclear when during the third trimester that delivery should be accomplished for maximal maternal safety and minimal fetal risk. In this research project, we will identify patients who are at least 34 weeks pregnant with mild preeclampsia. After informed consent to participate in the trial, we will randomize participants to either be delivered immediately or treated with observation and maternal-fetal surveillance in hospital as described previously with delivery at 38 weeks. There will be 110 participants enrolled in each arm of the study for a total of 220 patients who will be managed in the Wiser Hospital. We intend to analyze a number of maternal and fetal outcomes including cost comparisons for the care of both mother and fetus in the two groups of randomized patients. The findings should impact care of the pregnant patient with mild preeclampsia in the third trimester with regard to how early and how late in gestation that delivery should be accomplished for optimal maternal and perinatal benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Study participants (those diagnosed with mild preeclampsia) are admitted to hospital for standard inpatient management of their disease. |
| 2 | Experimental | Procedure: Delivery of infantStudy participants (those diagnosed with mild preeclampsia) are admitted to hospital and their infant is delivered as soon as possible after 34 weeks gestation. As there is no determined optimal time of delivery in these patients, delivery is the intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mild Preeclampsia equal to or greater than 34 weeks' and less that 38 weeks' gestation singleton gestation no maternal or fetal contraindications to conservative management
Key exclusion criteria (1 listed)
- Non-gestational diabetes Chronic hypertension Severe preeclampsia Non-reassuring fetal assessment intrauterine growth restriction fetal anomalies multiple gestation premature preterm rupture of membranes placenta previa unexplained vaginal bleeding antihypertensive use current gestation poor dating criteria contraindication to conservative management active labor at admission
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 |
|---|---|---|
| Delivery of infantVaginal delivery or cesarean section, whichever is indicated | Procedure or surgery | 2 |
Primary outcome
Progression to severe preeclampsia in the control group necessitating delivery of the infant.
Time frame: End of study
2 secondary outcomes
Maternal morbidity
Time frame: End of study
Fetal morbidity and mortality
Time frame: End of study
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 10 Feb 2017.
Related trials for Preeclampsia
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Michelle Y Owens, M.D. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of infant in people with Preeclampsia, run by University of Mississippi Medical Center 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 1 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 10 Feb 2017. 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. 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?
Progression to severe preeclampsia in the control group necessitating delivery of the infant. (time frame: End of study). 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 10 Feb 2017.