Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-01-24
Brief Title:
Treatment of Ectopic Pregnancy by Low Dose of Methotrexate
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Effectiveness and Safety of a New Methotrexate Regimen in Treatment of Undisturbed Tubal Ectopic Pregnancy A Pilot Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 15-20 of all pregnancies The most frequent location for ectopic pregnancy is the uterine tube 96-98 followed by the cervix 02-05 the ovary 02-20 and the abdomen 1 High-resolution ultrasonography and quantitative assessment of human chorionic gonadotropin hCG allow early diagnosis Mortalities are now therefore rare at 005 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 mgm2 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 mgm2 body surface should be administered If there is a drop of15 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 135 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 854 and 987 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None