Ectopic PregnancyNCT06300333
Treatment of Ectopic Pregnancy by Low Dose of Methotrexate
An observational study of Ectopic Pregnancy, run by Assiut University.
Trial summary
Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Methotrexate
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: the study will include women with undisturbed ectopic tubal pregnancy Bhcg < 5000 Haemodynamicaly stable Normal liver and kidney functions Commitment for fullow up untill ectopic pregnancy resolved
Who may be able to join
- undisturbed ectopic tubal pregnancy Bhcg < 5000
- Haemodynamicaly stable
- Normal liver and kidney functions
- Commitment for fullow up untill ectopic pregnancy resolvede
Who cannot join
- disturbed ectopic pregnancy
- Bhcg >5000
- Persistent abdominal pain
- Lactating women
- women with abnormal liver and kidney functions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of a New Methotrexate Regimen in Treatment of Undisturbed Tubal Ectopic Pregnancy : A Pilot Prospective Study
Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy
Read the detailed description
Ectopic pregnancy, also known as extrauterine pregnancy, occurs when the blastocyst implants outside the body of the uterus . The incidence is approximately 1.5-2.0 % of all pregnancies. The most frequent location for ectopic pregnancy is the uterine tube (96-98 %), followed by the cervix (0.2-0.5 %), the ovary (0.2-2.0 %), and the abdomen (˂1 %) . High-resolution ultrasonography and quantitative assessment of human chorionic gonadotropin (hCG) allow early diagnosis. Mortalities are now therefore rare, at 0.05 % of cases . Tubal pregnancy is the most frequent form and subject of the present article. Due to growth of the blastocyst, usually in the sixth to ninth gestational weeks, increasing wall tension develops in the uterine tube, with unilateral lower abdominal pain. If the uterine tube ruptures, intraabdominal bleeding may occur, with hematoperitoneum and possible hemorrhagic shock . The classic triad of symptoms-absence of menstruation, vaginal spotting, and lower abdominal pain-is often observed, but is not inevitable. The clinical findings can be extremely variable, ranging from symptom-free courses to the full picture of acute abdomen . Surgical treatment of tubal pregnancy is necessary in hemodynamically unstable patients and patients with acute pain or ultrasound evidence of free fluid in the abdomen. The standard surgical procedure is laparoscopic salpingotomy or salpingectomy . . Laparotomy is now only required in 1-2 % of patients with ectopic pregnancy. Tubepreserving surgery should always be aimed for, particularly in younger patients who are still planning to have children. Another treatment option is administration of methotrexate (MTX), a folic acid antagonist that blocks DNA/ RNA synthesis and thus cell division. In the single-dose protocol, methotrexate 50 mg/m2 body surface is administered on day 1 intramuscularly or intravenously , The hCG value is measured on days 4 and 7. If a drop in the hCG value by at least 15 % has not yet occurred, a second MTX dosage of 50 mg/m2 body surface should be administered. If there is a drop of[15 %, weekly hCG check-ups are carried out until the value is below the detection threshold of the relevant assay , Patients treated with the single dose require a second MTX injection in 13.5 % of cases, and less than 1 % required three or more MTX injections . However, there have been no dose-finding studies on the administration of MTX in patients with ectopic pregnancy, and several groups have reported good success rates of between 85.4 and 98.7 % using much lower dosages .the aim of this study is to use a low dose of Methotrexate in the treatment of tubal undisturbed ectopic pregnancy to get get less side e
- 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
use low dose of Methotrexate in treatment of un distectopic tubal pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy
we will follow up cases by investigationssand ultrasound and describe the results of using the low dose methotrexate in treatment of tubal undisturbed ectopic pregnancy
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Mohamed Abouelhassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300333
- Sponsor's protocol ID
- Ectopic tubal pregnancy
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marion LL, Meeks GR. Ectopic pregnancy: History, incidence, epidemiology, and risk factors. Clin Obstet Gynecol. 2012 Jun;55(2):376-86. doi: 10.1097/GRF.0b013e3182516d7b.
PubMed 22510618Practice Committee of American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008 Nov;90(5 Suppl):S206-12. doi: 10.1016/j.fertnstert.2008.08.049.
PubMed 19007632Karol D, Williamson M, Pereira N. Successful Expectant Management of a Tubal Ectopic Pregnancy. J Minim Invasive Gynecol. 2024 Feb;31(2):92-94. doi: 10.1016/j.jmig.2023.11.011. Epub 2023 Nov 30. No abstract available.
PubMed 38042476
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of a New Methotrexate Regimen in Treatment of Undisturbed Tubal Ectopic Pregnancy : A Pilot Prospective Study
- ClinicalTrials.gov ID
- NCT06300333
- Acronym / sponsor ID
- Ectopic tubal pregnancy
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy
Detailed description
Ectopic pregnancy, also known as extrauterine pregnancy, occurs when the blastocyst implants outside the body of the uterus . The incidence is approximately 1.5-2.0 % of all pregnancies. The most frequent location for ectopic pregnancy is the uterine tube (96-98 %), followed by the cervix (0.2-0.5 %), the ovary (0.2-2.0 %), and the abdomen (˂1 %) . High-resolution ultrasonography and quantitative assessment of human chorionic gonadotropin (hCG) allow early diagnosis. Mortalities are now therefore rare, at 0.05 % of cases . Tubal pregnancy is the most frequent form and subject of the present article. Due to growth of the blastocyst, usually in the sixth to ninth gestational weeks, increasing wall tension develops in the uterine tube, with unilateral lower abdominal pain. If the uterine tube ruptures, intraabdominal bleeding may occur, with hematoperitoneum and possible hemorrhagic shock . The classic triad of symptoms-absence of menstruation, vaginal spotting, and lower abdominal pain-is often observed, but is not inevitable. The clinical findings can be extremely variable, ranging from symptom-free courses to the full picture of acute abdomen . Surgical treatment of tubal pregnancy is necessary in hemodynamically unstable patients and patients with acute pain or ultrasound evidence of free fluid in the abdomen. The standard surgical procedure is laparoscopic salpingotomy or salpingectomy . . Laparotomy is now only required in 1-2 % of patients with ectopic pregnancy. Tubepreserving surgery should always be aimed for, particularly in younger patients who are still planning to have children. Another treatment option is administration of methotrexate (MTX), a folic acid antagonist that blocks DNA/ RNA synthesis and thus cell division. In the single-dose protocol, methotrexate 50 mg/m2 body surface is administered on day 1 intramuscularly or intravenously , The hCG value is measured on days 4 and 7. If a drop in the hCG value by at least 15 % has not yet occurred, a second MTX dosage of 50 mg/m2 body surface should be administered. If there is a drop of[15 %, weekly hCG check-ups are carried out until the value is below the detection threshold of the relevant assay , Patients treated with the single dose require a second MTX injection in 13.5 % of cases, and less than 1 % required three or more MTX injections . However, there have been no dose-finding studies on the administration of MTX in patients with ectopic pregnancy, and several groups have reported good success rates of between 85.4 and 98.7 % using much lower dosages .the aim of this study is to use a low dose of Methotrexate in the treatment of tubal undisturbed ectopic pregnancy to get get less side e
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the study will include women with undisturbed ectopic tubal pregnancy Bhcg < 5000 Haemodynamicaly stable Normal liver and kidney functions Commitment for fullow up untill ectopic pregnancy resolved
Key inclusion criteria (4 listed)
- undisturbed ectopic tubal pregnancy Bhcg < 5000
- Haemodynamicaly stable
- Normal liver and kidney functions
- Commitment for fullow up untill ectopic pregnancy resolvede
Key exclusion criteria (5 listed)
- disturbed ectopic pregnancy
- Bhcg >5000
- Persistent abdominal pain
- Lactating women
- women with abnormal liver and kidney 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 |
|---|---|---|
| Methotrexateuse low dose of Methotrexate in treatment of un distectopic tubal pregnancy | Drug | – |
Primary outcome
descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy
Time frame: 7 day
we will follow up cases by investigationssand ultrasound and describe the results of using the low dose methotrexate in treatment of tubal undisturbed ectopic pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 22510618Marion LL, Meeks GR. Ectopic pregnancy: History, incidence, epidemiology, and risk factors. Clin Obstet Gynecol. 2012 Jun;55(2):376-86. doi: 10.1097/GRF.0b013e3182516d7b.
- Background: PubMed 19007632Practice Committee of American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008 Nov;90(5 Suppl):S206-12. doi: 10.1016/j.fertnstert.2008.08.049.
- Background: PubMed 38042476Karol D, Williamson M, Pereira N. Successful Expectant Management of a Tubal Ectopic Pregnancy. J Minim Invasive Gynecol. 2024 Feb;31(2):92-94. doi: 10.1016/j.jmig.2023.11.011. Epub 2023 Nov 30. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abouelhassan, residant (+201552728816, Mohamedabouelhassan97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descriptive measurements of the results of using low dose methotrexate regimen in treatment of tubal undisturbed ectopic pregnancy (time frame: 7 day). 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 NCT06300333, which also lists 3 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 8 Mar 2024.