Expectant Management of Ectopic Pregnancy
Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04975984
Collaborator
(none)
50
1
5.4
9.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Expectant Management in Women Diagnosed With a Tubal Ectopic Pregnancy at Ain-Shams University Maternity Hospital Over the Period From January 1, 2016 to December 31, 2020
Anticipated Study Start Date
:
Jul 20, 2021
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Dec 31, 2021
Outcome Measures
Primary Outcome Measures
- resolution of hCG level [up to 12 weeks]
hCG levels measured every week till negative less than (<20 IU/l) up to 12 weeks
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
-
Hemodynamically stable with confirmed diagnosis of ectopic pregnancy on ultrasound scan.
-
No significant pelvic pain.
-
No hemoperitoneum.
-
No fetal heart in the ectopic pregnancy.
-
HCG level <5000 IU/L.
-
Expectant management was the first line of management offered to the patient after optimal counseling.
Exclusion Criteria:
-
all women with non tubal ectopic pregnancy
-
all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams university maternity hospital | Cairo | Egypt |
Sponsors and Collaborators
- Ain Shams University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Radwa Rasheedy Ali,
associate professor,
Ain Shams University
ClinicalTrials.gov Identifier:
NCT04975984
Other Study ID Numbers:
- ASU FM1
First Posted:
Jul 26, 2021
Last Update Posted:
Jul 26, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: