Expectant Management of Ectopic Pregnancy

July 14, 2021 updated by: Radwa Rasheedy Ali, Ain Shams University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Maternity Hospital
        • Contact:
          • Ahmed Essam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants included in this study will have the following criteria:

  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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resolution of hCG level
Time Frame: up to 12 weeks
hCG levels measured every week till negative less than (<20 IU/l) up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 20, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (ACTUAL)

July 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU FM1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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