PreeclampsiaPhase 4CLONCAPNCT01761916
Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure
A Phase 4 study testing CLONIDINE and CAPTOPRIL in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- CLONIDINE and CAPTOPRIL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypertensive disorders of pregnancy;
- Postpartum;
- Age 18 to 45 years;
- Very high blood pressure
Who cannot join
- Cardiac disease;
- Smoking;
- Use of illicit drugs that may interfere with maternal hemodynamics;
- Contraindications to the use of captopril: renal failure, chronic liver disease and hypersensitivity to the drug;
- Contraindications to the use of clonidine: sinus node disease, chronic liver disease and hypersensitivity to the drug;
- Inability to receive postpartum oral medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial for Effectiveness of Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure
The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.
Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.
Read more
The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.
Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.
There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.
The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.
Read the detailed description
The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.
Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.
The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.
Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.
There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.
The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.
A triple blind randomized clinical trial will be conducted. Postpartum women with hypertensive disorders of pregnancy, admitted to the obstetric ICU of IMIP will be included in the research. After inclusion in the study, drugs for for very high blood pressure, according to randomization(captopril and clonidine)will be used. clonidine and captopril are administered at a dose of 25mg and 0.1mg respectively. If there is no control of blood pressure in 20 minutes new hypotensive doses will be administered until a total of 150mg/day (six tablets) and Captopril 0.6 mg / day (six tablets) clonidine. After exceeded the allowed dose, other drugs may be associated. Initially, nifedipine (30mg/day to 60mg/day) according to the service routine. The goal of intervention is to maintain a systolic blood pressure below 170mmHg and diastolic pressure below 110mmHg, with the lowest possible dose. Thus, these medications will be increased should the need arise, according to measurements taken daily by the attending physician and the nursing staff.
- Conditions
- Preeclampsia
- Being tested
- CLONIDINE, CAPTOPRIL
- Keywords
- captopril, clonidine, pregnancy-induced hypertension,
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLONIDINEDrug
Also called CLON
Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)
CAPTOPRILDrug
Also called CAP
Postpartum patients with very high blood pressure will be treated with oral captopril (25mg)
| Study group | Role | What they receive |
|---|---|---|
| CLONIDINE | Experimental | Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg) Receives: Drug: CLONIDINE |
| CAPTOPRIL | Active comparator | Postpartum patients with very high blood pressure will be treated with oral CAPTOPRIL (25mg) Receives: Drug: CAPTOPRIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until resolution of very high blood pressure episode
The time until resolution of very high blood pressure episode after clonidin or captopril use.
Measured: During hospital stay, up until one month postpartum
Secondary outcomes (1)
Maternal outcomes
Daily average systolic blood pressure;Daily average diastolic blood pressure;Need for combination with other hypotensive agent for the peak pressure or antihypertensive treatment maintenance;Need for new dose of antihypertensive medication for very high blood pressure; Laboratory tests during the postpartum; Adverse effects of hypotensive used for very high blood pressure;Puerperal complications
Measured: During hospital stay, up until one month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Carlos Noronha, MD, Principal investigator, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761916
- Sponsor's protocol ID
- CLONCAP
- Acronym
- CLONCAP
- Status last verified
- Jun 2013
- First submitted
- 30 Oct 2012
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noronha Neto C C, Maia SS, Katz L, Coutinho IC, Souza AR, Amorim MM. Clonidine versus Captopril for Severe Postpartum Hypertension: A Randomized Controlled Trial. PLoS One. 2017 Jan 26;12(1):e0168124. doi: 10.1371/journal.pone.0168124. eCollection 2017.
PubMed 28125624Noronha-Neto C, Katz L, Coutinho IC, Maia SB, Souza AS, Amorim MM. Clonidine versus captopril for treatment of postpartum very high blood pressure: study protocol for a randomized controlled trial (CLONCAP). Reprod Health. 2013 Jul 30;10:37. doi: 10.1186/1742-4755-10-37.
PubMed 23899372
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for Effectiveness of Clonidine Versus Captopril for Treatment of Postpartum Very High Blood Pressure
- ClinicalTrials.gov ID
- NCT01761916
- Acronym / sponsor ID
- CLONCAP / CLONCAP
- Conditions
- Preeclampsia
- Keywords
- captopril, clonidine, pregnancy-induced hypertension,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jan 2013 (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.
The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.
Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.
The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.
Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.
There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.
The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.
Detailed description
The postpartum period represents a stage of the pregnancy-puerperal still rarely addressed scientifically. There are no reports in the literature and concrete enough to elucidate important issues, especially in the field of hypertension and pregnancy.
Searches based on current evidence concentrate their focus on the diagnosis of hypertensive disorders and treatment of these diseases maternofetais repercussions. However, the prognosis in the short and long term, as the BP outcome in mothers with severe preeclampsia, the most effective treatment for the control of hypertensive crisis and metabolic and cardiovascular events after two years of termination of pregnancy require further clarification.
The main idea for developing this research came from the clinical experience with the use of captopril in Obstetric ICU IMIP. This drug has long been used in postpartum women with severe preeclampsia or chronic hypertension exacerbated by pregnancy for control of hypertensive crisis and keeping pressure levels. Following the technical standards of the institution and during his administration, there were reports of side effects such as dry cough and nausea, beyond the threshold dose of 150mg daily captopril was easily achieved hindering control the use of hypotensive.
Alternative therapy, clonidine began to be used in mothers with some restriction on the use of ACE inhibitors and its hypotensive effect for peak pressure was satisfactory. What is not known yet is how long clonidine reduces high blood pressure and how long to leave stabilized compared to the use of captopril.
There are no reports in the literature databases, no randomized clinical trials that prove the effectiveness of clonidine for the treatment of hypotensive pressure peaks in this particular group of patients, even in comparison with other classes of antihypertensive drugs, especially captopril, to this purpose.
The investigators' primary assumption is that clonidine has better effectiveness in decreasing the frequency of pressure peaks when compared with captopril.
A triple blind randomized clinical trial will be conducted. Postpartum women with hypertensive disorders of pregnancy, admitted to the obstetric ICU of IMIP will be included in the research. After inclusion in the study, drugs for for very high blood pressure, according to randomization(captopril and clonidine)will be used. clonidine and captopril are administered at a dose of 25mg and 0.1mg respectively. If there is no control of blood pressure in 20 minutes new hypotensive doses will be administered until a total of 150mg/day (six tablets) and Captopril 0.6 mg / day (six tablets) clonidine. After exceeded the allowed dose, other drugs may be associated. Initially, nifedipine (30mg/day to 60mg/day) according to the service routine. The goal of intervention is to maintain a systolic blood pressure below 170mmHg and diastolic pressure below 110mmHg, with the lowest possible dose. Thus, these medications will be increased should the need arise, according to measurements taken daily by the attending physician and the nursing staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLONIDINE | Experimental | Drug: CLONIDINEPostpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg) |
| CAPTOPRIL | Active comparator | Drug: CAPTOPRILPostpartum patients with very high blood pressure will be treated with oral CAPTOPRIL (25mg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hypertensive disorders of pregnancy;
- Postpartum;
- Age 18 to 45 years;
- Very high blood pressure
Key exclusion criteria (6 listed)
- Cardiac disease;
- Smoking;
- Use of illicit drugs that may interfere with maternal hemodynamics;
- Contraindications to the use of captopril: renal failure, chronic liver disease and hypersensitivity to the drug;
- Contraindications to the use of clonidine: sinus node disease, chronic liver disease and hypersensitivity to the drug;
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 |
|---|---|---|
| CLONIDINEAlso: CLONPostpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg) | Drug | CLONIDINE |
| CAPTOPRILAlso: CAPPostpartum patients with very high blood pressure will be treated with oral captopril (25mg) | Drug | CAPTOPRIL |
Primary outcome
Time until resolution of very high blood pressure episode
Time frame: During hospital stay, up until one month postpartum
The time until resolution of very high blood pressure episode after clonidin or captopril use.
1 secondary outcome
Maternal outcomes
Time frame: During hospital stay, up until one month postpartum
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 Jul 2013.
- Derived from this study: PubMed 28125624Noronha Neto C C, Maia SS, Katz L, Coutinho IC, Souza AR, Amorim MM. Clonidine versus Captopril for Severe Postpartum Hypertension: A Randomized Controlled Trial. PLoS One. 2017 Jan 26;12(1):e0168124. doi: 10.1371/journal.pone.0168124. eCollection 2017.
- Derived from this study: PubMed 23899372Noronha-Neto C, Katz L, Coutinho IC, Maia SB, Souza AS, Amorim MM. Clonidine versus captopril for treatment of postpartum very high blood pressure: study protocol for a randomized controlled trial (CLONCAP). Reprod Health. 2013 Jul 30;10:37. doi: 10.1186/1742-4755-10-37.
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
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.
Carlos Noronha, MD principal investigator
IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CLONIDINE and CAPTOPRIL in people with Preeclampsia, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 6 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 Jul 2013. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time until resolution of very high blood pressure episode (time frame: During hospital stay, up until one month postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761916, which also lists 2 linked publications.
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 Jul 2013.