Ectopic PregnancyPhase 4NCT01876004
Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
A Phase 4 study testing Methotrexate in people with Ectopic Pregnancy, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamic stability
- Initial β-hCG <2000 mIU / mL
- Titers of β-hCG in decline in 48 hours before treatment
- Adnexal mass <5.0 cm
- Desire for future pregnancy
Who cannot join
- Alive embryo
- Ectopic pregnancy other than in tubal location
- Pregnancy of unknown location
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.
- Conditions
- Ectopic Pregnancy
- Being tested
- Methotrexate, Placebo
- Keywords
- ectopic pregnancy, methotrexate, human chorionic gonadotropin beta subunit, expectant management
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
50 mg/m2, IM (intramuscularly), single dose
PlaceboDrug
Prescribed Placebo IM (intramuscularly), single dose
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Administered a single intramuscular dose of 50 mg/m2 of Methotrexate. Receives: Drug: Methotrexate |
| Placebo | Placebo comparator | Prescribed Placebo intramuscularly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of treatment
β-hCG negative (<5 mIU / mL)
Measured: 6 months
Time required for titers of β-hCG to become negative
After medication, monitoring will be done by measurement of β-hCG in the 4th and 7th day. If there ia a decrease > 15% in this range (4th and 7th), patient will be followed with weekly dosing of β-hCG until negative titers
Measured: 6 weeks
Secondary outcomes (2)
Blood tests before treatment with Methotrexate and Placebo
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
Measured: 6 months
Blood tests after treatment with Methotrexate and Placebo
Average value for tests: complete blood count, liver and renal function in the groups Methotrexate and Placebo before and after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies 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, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila Matthiesen e Silva, Federal University of São Paulo
- Investigators
- Julio Elito Junior, Study director, Federal University of São PauloLuiz Camano, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876004
- Sponsor's protocol ID
- CEP UNIFESP 0772/11
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT01876004
- Acronym / sponsor ID
- CEP UNIFESP 0772/11
- Conditions
- Ectopic Pregnancy
- Keywords
- ectopic pregnancy, methotrexate, human chorionic gonadotropin beta subunit, expectant management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Jun 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.
Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: MethotrexateAdministered a single intramuscular dose of 50 mg/m2 of Methotrexate. |
| Placebo | Placebo comparator | Drug: PlaceboPrescribed Placebo intramuscularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemodynamic stability
- Initial β-hCG <2000 mIU / mL
- Titers of β-hCG in decline in 48 hours before treatment
- Adnexal mass <5.0 cm
- Desire for future pregnancy
Key exclusion criteria (3 listed)
- Alive embryo
- Ectopic pregnancy other than in tubal location
- Pregnancy of unknown location
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 |
|---|---|---|
| Methotrexate50 mg/m2, IM (intramuscularly), single dose | Drug | Methotrexate |
| PlaceboPrescribed Placebo IM (intramuscularly), single dose | Drug | Placebo |
Primary outcome
success of treatment
Time frame: 6 months
β-hCG negative (<5 mIU / mL)
Time required for titers of β-hCG to become negative
Time frame: 6 weeks
After medication, monitoring will be done by measurement of β-hCG in the 4th and 7th day. If there ia a decrease > 15% in this range (4th and 7th), patient will be followed with weekly dosing of β-hCG until negative titers
2 secondary outcomes
Blood tests before treatment with Methotrexate and Placebo
Time frame: 6 months
Blood tests after treatment with Methotrexate and Placebo
Time frame: 6 months
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 12 Jun 2013.
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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.
Julio Elito Junior study director
Federal University of São Paulo
Luiz Camano study director
Federal University of São Paulo
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 Methotrexate in people with Ectopic Pregnancy, run by Federal University of São Paulo 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 5 inclusion and 3 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 12 Jun 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. 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.
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?
success of treatment (time frame: 6 months). The study lists 2 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 12 Jun 2013.