Woman With Tubal Ectopic PregnancyNCT04951011
Different Treatment Options for Tubal Ectopic Pregnancy:- A Systmatic Review
An observational study of Woman With Tubal Ectopic Pregnancy, run by Sohag University at 1 site in Egypt.
Trial summary
Ectopic pregnancy is an early pregnancy complication in which a fertilized ovum implant outside the uterine cavity. Implantation may occur anywhere along the reproductive tract with the most common implantation site being the fallopian tube. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Woman With Tubal Ectopic Pregnancy
- What is being tested?
- Serum beta HCG
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 1 Jan 2022
- 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 15 to 40 years
- Women only
- Child, Adult
Study population: Sample size: All articles fulfilling the inclusion criteria within the last five years. Study tools: Primary data will be re-analyzed statistically and processed data to be compared. Secondary data will be analyzed for correlation between the type of anastomosis (hand sewing vs. staplers) and between measurements outcome (leakage and, stricture and fistula formation). • Study procedure: The study will start by searching articles using the key words and then downloading papers that fulfill the inclusion criteria and excluding papers with exclusion criteria. These papers will be examined by the supervisors to make sure of finding the appropriate source of data and then I will start working with the statistical supervisor and put data on R-based software for meta-analysis and start conducting the study.
Who may be able to join
- RCTs and observational studies
- All types of ectopic pregnancies.
- All types of treatments and medications for ectopic pregnancies.
- The long-term survival of patients with or without complications.
- Successful pregnancy and birth.
Who cannot join
- Articles of failed treatments of ectopic pregnancies.
- Articles with over all P value > 0.05.
- Articles for which the full text is not available in English.
Trial locations and contacts
1 site in 1 country.
Yasser A Helmy, Professor contact
About this study
Ectopic pregnancy is an early pregnancy complication in which a fertilized ovum implant outside the uterine cavity. Implantation may occur anywhere along the reproductive tract with the most common implantation site being the fallopian tube. The incidence of ectopic pregnancy is 1% of pregnant women, and may seriously compromise women's health and future fertility.
Currently, ectopic pregnancy can be often diagnosed before the woman's condition has deteriorated, which has altered the former clinical picture of a lifethreatening disease into a more benign condition in frequently asymptomatic women.
- Conditions
- Woman With Tubal Ectopic Pregnancy
- Being tested
- Serum beta HCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum beta HCGDiagnostic test
Raising numbers of S BHCG or decreasing with different management of tubal Ectopic Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal and Transvaginal Ultrasound:
To detect the appearance of any mass at the adenexa,or intrauterine gestational sac in case of heterotopic pregnancy or misdiagnosis of ectopic pregnancy.
To detect, if there's collection at the pelvis or freely at the abdomen in the case of disturbed ectopic pregnancy.
Measured: 6 Monthes
S.bHCG:
in cases of expectant management,and medical treatment to detect level of S.bHCG after administration of methotrexate to decide to continue with medical treatment and give another doses or failure of this line and decide another line of management.
Also,at the expectant management to close follow up the patient.
Measured: 6 Monthes
Diagnostic laparoscopy
In cases of early,undisturbed ectopic pregnancy and may use also,for therapy Laparoscopic salpingostomy and/or salpingectomy
Measured: 6 Monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Woman With Tubal Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelhameed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951011
- Sponsor's protocol ID
- Soh-Med-21-06-05
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Barnhart KT. Clinical practice. Ectopic pregnancy. N Engl J Med. 2009 Jul 23;361(4):379-87. doi: 10.1056/NEJMcp0810384. No abstract available.
PubMed 19625718Bagshawe KD, Dent J, Newlands ES, Begent RH, Rustin GJ. The role of low-dose methotrexate and folinic acid in gestational trophoblastic tumours (GTT). Br J Obstet Gynaecol. 1989 Jul;96(7):795-802. doi: 10.1111/j.1471-0528.1989.tb03318.x.
PubMed 2548568Elson J, Tailor A, Banerjee S, Salim R, Hillaby K, Jurkovic D. Expectant management of tubal ectopic pregnancy: prediction of successful outcome using decision tree analysis. Ultrasound Obstet Gynecol. 2004 Jun;23(6):552-6. doi: 10.1002/uog.1061.
PubMed 15170794
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Treatment Options for Tubal Ectopic Pregnancy:- A Systmatic Review
- ClinicalTrials.gov ID
- NCT04951011
- Acronym / sponsor ID
- Soh-Med-21-06-05
- Conditions
- Woman With Tubal Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 6 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.
Ectopic pregnancy is an early pregnancy complication in which a fertilized ovum implant outside the uterine cavity. Implantation may occur anywhere along the reproductive tract with the most common implantation site being the fallopian tube. The incidence of ectopic pregnancy is 1% of pregnant women, and may seriously compromise women's health and future fertility.
Currently, ectopic pregnancy can be often diagnosed before the woman's condition has deteriorated, which has altered the former clinical picture of a lifethreatening disease into a more benign condition in frequently asymptomatic women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Sample size: All articles fulfilling the inclusion criteria within the last five years. Study tools: Primary data will be re-analyzed statistically and processed data to be compared. Secondary data will be analyzed for correlation between the type of anastomosis (hand sewing vs. staplers) and between measurements outcome (leakage and, stricture and fistula formation). • Study procedure: The study will start by searching articles using the key words and then downloading papers that fulfill the inclusion criteria and excluding papers with exclusion criteria. These papers will be examined by the supervisors to make sure of finding the appropriate source of data and then I will start working with the statistical supervisor and put data on R-based software for meta-analysis and start conducting the study.
Key inclusion criteria (5 listed)
- RCTs and observational studies
- All types of ectopic pregnancies.
- All types of treatments and medications for ectopic pregnancies.
- The long-term survival of patients with or without complications.
- Successful pregnancy and birth.
Key exclusion criteria (3 listed)
- Articles of failed treatments of ectopic pregnancies.
- Articles with over all P value > 0.05.
- Articles for which the full text is not available in English.
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 |
|---|---|---|
| Serum beta HCGRaising numbers of S BHCG or decreasing with different management of tubal Ectopic Pregnancy | Diagnostic test | – |
Primary outcome
Abdominal and Transvaginal Ultrasound:
Time frame: 6 Monthes
To detect the appearance of any mass at the adenexa,or intrauterine gestational sac in case of heterotopic pregnancy or misdiagnosis of ectopic pregnancy. To detect, if there's collection at the pelvis or freely at the abdomen in the case of disturbed ectopic pregnancy.
S.bHCG:
Time frame: 6 Monthes
in cases of expectant management,and medical treatment to detect level of S.bHCG after administration of methotrexate to decide to continue with medical treatment and give another doses or failure of this line and decide another line of management. Also,at the expectant management to close follow up the patient.
Diagnostic laparoscopy
Time frame: 6 Monthes
In cases of early,undisturbed ectopic pregnancy and may use also,for therapy Laparoscopic salpingostomy and/or salpingectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Background: PubMed 19625718Barnhart KT. Clinical practice. Ectopic pregnancy. N Engl J Med. 2009 Jul 23;361(4):379-87. doi: 10.1056/NEJMcp0810384. No abstract available.
- Background: PubMed 2548568Bagshawe KD, Dent J, Newlands ES, Begent RH, Rustin GJ. The role of low-dose methotrexate and folinic acid in gestational trophoblastic tumours (GTT). Br J Obstet Gynaecol. 1989 Jul;96(7):795-802. doi: 10.1111/j.1471-0528.1989.tb03318.x.
- Background: PubMed 15170794Elson J, Tailor A, Banerjee S, Salim R, Hillaby K, Jurkovic D. Expectant management of tubal ectopic pregnancy: prediction of successful outcome using decision tree analysis. Ultrasound Obstet Gynecol. 2004 Jun;23(6):552-6. doi: 10.1002/uog.1061.
- Individual participant dataSharing planned: Yes
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.
Yasser A Helmy, Professor contact
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 Woman With Tubal Ectopic Pregnancy, run by Sohag 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 5 inclusion and 3 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 6 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 Mohamed A Mohamed, Master (01060386207, mohamed011161@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal and Transvaginal Ultrasound: (time frame: 6 Monthes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04951011, which also lists 3 linked publications.
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 6 Jul 2021.