Ectopic PregnancyNCT04975984
Expectant Management of Ectopic Pregnancy
An observational study of Ectopic Pregnancy, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- qualitative hCG levels and ultrasound criteria
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- all women with non tubal ectopic pregnancy
- all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- qualitative hCG levels and ultrasound criteria
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative hCG levels and ultrasound criteriaDiagnostic test
detect upper limit of qualitative hCG levels associated with successful expectant management of ectopic pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution of hCG level
hCG levels measured every week till negative less than (<20 IU/l) up to 12 weeks
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start20 Jul 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975984
- Sponsor's protocol ID
- ASU FM1
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04975984
- Acronym / sponsor ID
- ASU FM1
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- all women with non tubal ectopic pregnancy
- all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative hCG levels and ultrasound criteriadetect upper limit of qualitative hCG levels associated with successful expectant management of ectopic pregnancy | Diagnostic test | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Ectopic Pregnancy
Recruiting
Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
Genital Diseases, Female, Ectopic Pregnancy
Active, not recruitingPhase 2/3
Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.
Ectopic Pregnancy
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruitingObservational study
Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
Pregnancy of Unknown Location (PUL)
Not yet recruitingPhase 2
Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Ectopic Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa Rasheedy, MD (01283492979 ext. 02, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resolution of hCG level (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021; AzTrials last refreshed its copy on 2 Nov 2026.