Ectopic PregnancyNCT05208034
Medical Treatment in Ectopic Tubal Pregnancy
A study testing Methotrexate in people with Ectopic Pregnancy, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 30 Jul 2021
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of tubal ectopic pregnancy.
- Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
- Gestational sac with largest diameter as 4cm.
- Willing to take methotrexate treatment.
- Willing to follow up.
Who cannot join
- Heterotrophic pregnancy
- Persistent tubal pregnancy
- Embryonic cardiac motion
- Suspected tubal rupture
- Past history of harmful effects of methotrexate treatment on organ functions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.
Read the detailed description
Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.
A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.
- Conditions
- Ectopic Pregnancy
- Being tested
- Methotrexate
- 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
Two-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7.
| Study group | Role | What they receive |
|---|---|---|
| single-dose group | No intervention | Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment). |
| two-dose group | Experimental | Women allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
In single-dose group,β-hCG levels were measured at day-4 and 7 and if β-hCG decreased >15% between day-4 and day-7, the treatment was labeled successful.
In two-dose group, in case 15% reduction in β-hCG level was observed at day-14, the treatment was labeled as success.
Measured: 4-14 days
Secondary outcomes (2)
frequency of Side-effects of treatment
monitoring for the side effects during the treatment duration
Measured: 1-14 days
β-hCG Resolution Time
Time taken for β-hcg resolution to reduce below 15%
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Jan 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rashida Parveen, Nishtar Medical University
- Investigators
- Rashida Parveen, FCPS, Principal investigator, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208034
- Sponsor's protocol ID
- NishtarMU12
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 9 Feb 2022
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Success With Two Doses of Methotrexate vs Single Dose of Methotrexate in Ectopic Tubal Pregnancy
- ClinicalTrials.gov ID
- NCT05208034
- Acronym / sponsor ID
- NishtarMU12
- Conditions
- Ectopic Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 26 Jan 2022 (actual)
- 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.
Ectopic pregnancy (EP) is estimated to be responsible for approximately 20% of all pregnancy-related mortality and 46% early pregnancy mortality.1 Hemodynamically stable women with EP are frequently managed with methotrexate (MTX) while multiple protocols like fixed multiple doses, single-dose as well as two-dose regimens have been in practice for treating EP, but no consensus exists regarding the optimum dosage regimen.
Detailed description
Literature reports multiple dosage regimens of MTX to be associated with increased rates of side effects. Single dose protocol has good compliance and fewer side effects but is linked with lower success rates in comparison to multiple dose protocols.
A new treatment protocol involving "two-doses" of MTX for medical management of EP was introduced in 2007 but most of the research conducted so far has been retrospective in nature and limitations in study designs. No such study in recent years has been done in Pakistan to compare the success and safety of single-dose and two-dose MTX protocols so this study was planned to compare the success rates and safety of two-doses of MTX versus single dose of MTX in tubal EP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| single-dose group | No intervention | –Women in single-dose group were administered a single-dose of intramuscular methotrexate as 50 mg/m2 on day-zero (the start of treatment). |
| two-dose group | Experimental | Drug: MethotrexateWomen allocated to two-dose group were administered intramuscular methotrexate as 50mg/m2 at day-zero and 7 while measurement of β-hCG was ordered at day-14. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of tubal ectopic pregnancy.
- Pre-treatment beta-human chorionic gonadotrophin (β-hCG) level below 1500 mIU/ml.
- Gestational sac with largest diameter as 4cm.
- Willing to take methotrexate treatment.
- Willing to follow up.
Key exclusion criteria (5 listed)
- Heterotrophic pregnancy
- Persistent tubal pregnancy
- Embryonic cardiac motion
- Suspected tubal rupture
- Past history of harmful effects of methotrexate treatment on organ functions.
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 |
|---|---|---|
| MethotrexateTwo-doses of intramuscular methotrexate as 50mg/m2.. One at at day-zero and 2nd at day 7. | Drug | two-dose group |
Primary outcome
success rate
Time frame: 4-14 days
In single-dose group,β-hCG levels were measured at day-4 and 7 and if β-hCG decreased >15% between day-4 and day-7, the treatment was labeled successful. In two-dose group, in case 15% reduction in β-hCG level was observed at day-14, the treatment was labeled as success.
2 secondary outcomes
frequency of Side-effects of treatment
Time frame: 1-14 days
β-hCG Resolution Time
Time frame: 1-14 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 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Ectopic Pregnancy
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
RecruitingPhase 2
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)
Active, not recruitingPhase 2
Metyrapone for Mild Autonomous Cortisol Secretion (MACS)
Autonomous Cortisol Secretion, Mild Autonomous Cortisol Secretion (MACS)
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.
Rashida Parveen, FCPS principal investigator
Nishtar Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate in people with Ectopic Pregnancy, run by Nishtar Medical University at 1 site in Pakistan.
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 5 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 9 Feb 2022. 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 Pakistan. 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?
success rate (time frame: 4-14 days). 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 9 Feb 2022.