Expectant Management of Ectopic Pregnancy

NCT04975984 | Unknown

• 1 other identifier: ASU FM1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• resolution of hCG level

  hCG levels measured every week till negative less than (\<20 IU/l) up to 12 weeks

  up to 12 weeks

Interventions

qualitative hCG levels and ultrasound criteria DIAGNOSTIC_TEST

detect upper limit of qualitative hCG levels associated with successful expectant management of ectopic pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• all women with non tubal ectopic pregnancy
• all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university maternity hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Radwa Rasheedy, MD

CONTACT

01283492979; radwaebed@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 26, 2021
• Study Start: July 20, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)