ClinicalTrials.gg
Not yet recruitingNCT06300333Updated Mar 8, 2024

Treatment of Ectopic Pregnancy by Low Dose of Methotrexate

An observational study in Ectopic Pregnancy, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Ectopic Pregnancy

Browse trials for

03

In context

Pregnancy, Ectopic

83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.

This study's planned enrollment of 20 is below the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.

Browse Pregnancy, Ectopic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • disturbed ectopic pregnancy
  • Bhcg >5000
  • Persistent abdominal pain
  • Lactating women
  • women with abnormal liver and kidney functions
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Interventions

  • use low dose of Methotrexate in treatment of un distectopic tubal pregnancy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 day

07

Study locations

No study locations are listed for this record.

08

References and documents

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 22510618 ↗
  • Practice 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 19007632 ↗
  • Karol 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2024; primary completion for Mar 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2024
First posted
Mar 8, 2024
StartEst.
Mar 2024
Primary completionEst.
Mar 2025
CompletionEst.
Mar 2025
Last update
Mar 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06300333
Lead sponsor
Assiut University
Responsible party
Mohamed Ali Mohamed Abouelhassan (principal invistigator, Assiut University) — Principal investigator
First posted
Mar 8, 2024
Start date
Mar 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Mar 8, 2024

Study contacts

Mohamed Abouelhassan, residant
Contact
Mohamedabouelhassan97@gmail.com
+201552728816
Ahmed Ibrahim hasanein, Prof
Contact
ahmedibrahimhas@yahoo.com
01000024321

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion