Different Treatment Options for Tubal Ectopic Pregnancy:- A Systmatic Review

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 Overview

• Status: Recruiting
• Conditions: Woman With Tubal Ectopic Pregnancy
• Intervention / Treatment: Diagnostic test: Serum beta HCG

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

Contacts and Locations

• Study Contact: Name: Mohamed A Mohamed, Master; Phone Number: 01060386207; Email: mohamed011161@med.sohag.edu.eg
• Study Contact Backup: Name: Yasser A Helmy, Professor

Study Locations

• Egypt
  • Akhmim, Egypt
    • Recruiting
    • Sohag
    • Contact: Hassan Noman, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability 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.

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (ACTUAL): July 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 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; Pregnancy, Tubal
• Other Study ID Numbers: Soh-Med-21-06-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No