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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04975984
Other study ID # ASU FM1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 20, 2021
Est. completion date December 31, 2021

Study information

Verified date July 2021
Source Ain Shams University
Contact Radwa Rasheedy, MD
Phone 01283492979
Email radwaebed@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to assess the efficacy and safety of expectant management in the treatment of tubal ectopic pregnancy and identification of different factors that can be used to predict its success.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - all women who underwent expectant management as the first line of management offered after optimal counseling during the period from January 1, 2016 to December 31, 2020. 1. Hemodynamically stable with confirmed diagnosis of ectopic pregnancy on ultrasound scan. 2. No significant pelvic pain. 3. No hemoperitoneum. 4. No fetal heart in the ectopic pregnancy. 5. HCG level <5000 IU/L. 6. Expectant management was the first line of management offered to the patient after optimal counseling. Exclusion Criteria: 1. all women with non tubal ectopic pregnancy 2. all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
qualitative hCG levels and ultrasound criteria
detect upper limit of qualitative hCG levels associated with successful expectant management of ectopic pregnancy

Locations

Country Name City State
Egypt Ain Shams university maternity hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary resolution of hCG level hCG levels measured every week till negative less than (<20 IU/l) up to 12 weeks up to 12 weeks
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