NCT04951011

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

June 27, 2021

Last Update Submit

July 2, 2021

Conditions

Woman With Tubal Ectopic Pregnancy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    6 Monthes

  • Diagnostic laparoscopy

    In cases of early,undisturbed ectopic pregnancy and may use also,for therapy Laparoscopic salpingostomy and/or salpingectomy

    6 Monthes

Interventions

Serum beta HCGDIAGNOSTIC_TEST

Raising numbers of S BHCG or decreasing with different management of tubal Ectopic Pregnancy

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag

Akhmīm, Egypt

RECRUITING

Related Publications (3)

  • Barnhart KT. Clinical practice. Ectopic pregnancy. N Engl J Med. 2009 Jul 23;361(4):379-87. doi: 10.1056/NEJMcp0810384. No abstract available.

    PMID: 19625718BACKGROUND

  • Bagshawe 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.

    PMID: 2548568BACKGROUND

  • Elson 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.

    PMID: 15170794BACKGROUND

Central Study Contacts

Mohamed A Mohamed, Master

CONTACT

01060386207mohamed011161@med.sohag.edu.eg

Yasser A Helmy, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at obstitrics and gyncology department sohag university hospital

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 6, 2021

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Locations

EG(1)