Expectant Management of Ectopic Pregnancy

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: Ectopic Pregnancy
• Intervention / Treatment: Diagnostic test: qualitative hCG levels and ultrasound criteria

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

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: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature
• 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