HypertensionPhase 2/3NCT01988298
Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia
A Phase 2/3 study testing Ibuprofen and Acetaminophen in people with Hypertension, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 1 site in Panama.
Trial summary
Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Ibuprofen and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePanama
- Study dates
- Oct 2013to Feb 2015
- Phase
- Phase 2/3
- 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 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia
Who cannot join
- sensitivities to ibuprofen cesarean delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.
Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension.
The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.
Read the detailed description
Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.
- Conditions
- Hypertension
- Being tested
- Ibuprofen, Acetaminophen
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Ibuprofen in pre-eclampsia
Ibuprofen 400 mg each 8 hours
AcetaminophenDrug
Also called Acetaminophen in pre-eclampsia
Control group
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days. Receives: Drug: Ibuprofen |
| Acetaminophen | Active comparator | Acetaminophen 1 g oral each 6 hours, 2-3 days. Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of postpartum hypertension
hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory
Measured: levels of hypertension up to 4 days post paertum
Secondary outcomes (1)
complications
Renal failure, symptoms, bleeding
Measured: complications during the postpartum period (4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
- Investigators
- Paulino Vigil-De Gracia, MD, Study chair, Complejo Hospitalario Caja de Seguro social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988298
- Sponsor's protocol ID
- Complejoh 02
- Status last verified
- Jul 2015
- First submitted
- 31 Oct 2013
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.
- ClinicalTrials.gov ID
- NCT01988298
- Acronym / sponsor ID
- Complejoh 02
- Conditions
- Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias MadridUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Nov 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.
Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension.
The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.
Detailed description
Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: IbuprofenExperimental: Ibuprofen 400 mg each 8 hours for 2-3 days. |
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen 1 g oral each 6 hours, 2-3 days. |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia
Key exclusion criteria (1 listed)
- sensitivities to ibuprofen cesarean delivery
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 |
|---|---|---|
| IbuprofenAlso: Ibuprofen in pre-eclampsiaIbuprofen 400 mg each 8 hours | Drug | Ibuprofen |
| AcetaminophenAlso: Acetaminophen in pre-eclampsiaControl group | Drug | Acetaminophen |
Primary outcome
level of postpartum hypertension
Time frame: levels of hypertension up to 4 days post paertum
hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory
1 secondary outcome
complications
Time frame: complications during the postpartum period (4 days)
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 28 Jul 2015.
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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.
Paulino Vigil-De Gracia, MD study chair
Complejo Hospitalario Caja de Seguro social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ibuprofen and Acetaminophen in people with Hypertension, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 1 site 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 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 28 Jul 2015. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
level of postpartum hypertension (time frame: levels of hypertension up to 4 days post paertum). 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 28 Jul 2015.