Pre-EclampsiaNCT03028194
Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia
A study testing Curettage in people with Pre-Eclampsia and Eclampsia, run by Saint Thomas Hospital, Panama at 2 sites in Panama.
Trial summary
Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Pre-Eclampsia, Eclampsia
- What is being tested?
- Curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 2 sitesPanama
- Study dates
- 1 Oct 2015to 11 Dec 2016
- 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 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Gestational age 24 weeks or more.
- Preeclampsia/eclampsia
Who cannot join
- Epilepsy or seizures previous to pregnancy.
- Renal disease
- Heart disease
- Liver disease
Trial locations and contacts
2 sites in 1 country.
Panama2 sites
Saint Thomas H
Panama City, Provincia de Panamá
Saint Thomas Maternity Hospital
Panama City, Provincia de Panamá
About this study
Official title: Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial
Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.
Read the detailed description
To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.
A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.
- Conditions
- Pre-Eclampsia, Eclampsia
- Being tested
- Curettage, Placebo
- Keywords
- Pre-eclampsia, Eclampsia, Postpartum uterine curettage
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurettageProcedure or surgery
Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.
PlaceboProcedure or surgery
No procedure after delivery of the placenta
| Study group | Role | What they receive |
|---|---|---|
| Curettage | Experimental | Postpartum uterine curettage performed immediately after delivery of the placenta. Receives: Procedure: Curettage |
| Placebo | Placebo comparator | No procedure performed after delivery of the placenta. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Arterial blood pressure
Measured: 6 hours
Systolic and diastolic blood pressure
Arterial blood pressure
Measured: 12 hours
Systolic and diastolic blood pressure
Arterial blood pressure
Measured: 24 hours
Systolic and diastolic blood pressure
Arterial Blood pressure
Measured: 48 hours
Secondary outcomes (5)
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Number of patients with an abnormal laboratory value
Measured: 6 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Number of patients with an abnormal laboratory value
Measured: 12 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Number of patients with an abnormal laboratory value
Measured: 24 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Number of patients with an abnormal laboratory value
Measured: 48 hours
Seizures
Number of participants with the development of seizures after birth.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Oct 2015
- Primary completion31 Oct 2016
- Study completion11 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Study chair, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028194
- Sponsor's protocol ID
- MHST2014-06
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 23 Jan 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 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03028194
- Acronym / sponsor ID
- MHST2014-06
- Conditions
- Pre-Eclampsia, Eclampsia
- Keywords
- Pre-eclampsia, Eclampsia, Postpartum uterine curettage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 11 Dec 2016 (actual)
- First posted
- 23 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.
Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.
Detailed description
To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.
A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curettage | Experimental | Procedure: CurettagePostpartum uterine curettage performed immediately after delivery of the placenta. |
| Placebo | Placebo comparator | Procedure: PlaceboNo procedure performed after delivery of the placenta. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Gestational age 24 weeks or more.
- Preeclampsia/eclampsia
Key exclusion criteria (4 listed)
- Epilepsy or seizures previous to pregnancy.
- Renal disease
- Heart disease
- Liver disease
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 |
|---|---|---|
| CurettagePostpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta. | Procedure or surgery | Curettage |
| PlaceboNo procedure after delivery of the placenta | Procedure or surgery | Placebo |
Primary outcome
Systolic and diastolic blood pressure
Time frame: 6 hours
Arterial blood pressure
Systolic and diastolic blood pressure
Time frame: 12 hours
Arterial blood pressure
Systolic and diastolic blood pressure
Time frame: 24 hours
Arterial blood pressure
Systolic and diastolic blood pressure
Time frame: 48 hours
Arterial Blood pressure
5 secondary outcomes
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time frame: 6 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time frame: 12 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time frame: 24 hours
Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).
Time frame: 48 hours
Seizures
Time frame: 48 hours
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 23 Jan 2017.
- Individual participant dataSharing planned: No
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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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
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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.
Osvaldo Reyes, MD study chair
Saint Thomas Hospital, Panama
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curettage in people with Pre-Eclampsia and Eclampsia, run by Saint Thomas Hospital, Panama at 2 sites in Panama.
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 4 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Panama. 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?
Systolic and diastolic blood pressure (time frame: 6 hours). The study lists 4 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 23 Jan 2017.