Treatment of Ectopic Pregnancy by Low Dose of Methotrexate

March 2, 2024 updated by: Mohamed Ali Mohamed Abouelhassan, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • undisturbed ectopic tubal pregnancy Bhcg < 5000
  • Haemodynamicaly stable
  • Normal liver and kidney functions
  • Commitment for fullow up untill ectopic pregnancy resolvede

Exclusion Criteria:

  • disturbed ectopic pregnancy
  • Bhcg >5000
  • Persistent abdominal pain
  • Lactating women
  • women with abnormal liver and kidney functions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

March 2, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ectopic tubal pregnancy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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