NCT06300333

Brief Summary

Evaluate the efficacy and safety of the use of low dose regimen of methotrexate in treatment of tubal undisturbed tubal ectopic pregnancy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 8, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

January 24, 2024

Last Update Submit

March 2, 2024

Conditions

Outcome Measures

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

    7 day

Interventions

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 22510618BACKGROUND
  • 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.

    PMID: 19007632BACKGROUND
  • 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.

    PMID: 38042476BACKGROUND

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Mohamed Abouelhassan, residant

CONTACT

Ahmed Ibrahim hasanein, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal invistigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

March 8, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share