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Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment. (EENCBE)

Primary Purpose

Ectopic Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
Angola
Study Type
Interventional
Intervention
Medical treatment
Sponsored by
EDGREM Investimentos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy focused on measuring uncomplicated ectopic pregnancy methotrexate

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Patient presenting with Ectopic Pregnancy, associated with quantitative titers of βHCG ≥ 100 mUI / ml, without intrauterine gestational sac.

Patient presenting uncomplicated Ectopic Pregnancy with an adnexal mass diameter ≤4 cm diagnosed by abdominal and / or transvaginal ultrasonography.

Absence of heartbeat. No toxicity to MTX. Normal laboratory tests (blood count, coagulogram, liver and kidney function). Hemodynamic stability.

Exclusion Criteria:

  • Complicated Ectopic Pregnancy.
  • Ectopic pregnancy is out of the tuba on ultrasound
  • Patients with Immunosuppression.
  • Allergy to MTX.
  • Patients with Active Respiratory Disease, Blood Dyspasia, Peptic Ulcer, Renal Insufficiency and Hepatic Insufficiency.
  • Do not accept to participate in the study.

Sites / Locations

  • Maria Dolores Reguera SaboridoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medical treatment

Surgical treatment

Arm Description

By administering a single intramuscular dose of 50mg / m2 / Sc of Methotrexate.

Will be performed by laparoscopy or laparotomy, using the Linear Salpingostomy technique.

Outcomes

Primary Outcome Measures

Incidence of Ipsilateral tubal patency
Incidence of Ipsilateral tubal patency

Secondary Outcome Measures

Incidence of Achieve the gestation and the culmination.
Incidence of Achieve the gestation and the culmination.

Full Information

First Posted
November 8, 2021
Last Updated
November 24, 2021
Sponsor
EDGREM Investimentos
Collaborators
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05136274
Brief Title
Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment.
Acronym
EENCBE
Official Title
Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment in Uncomplicated Ectopic Pregnancy, "Hospital General", Angola 2021-2022
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
August 17, 2022 (Anticipated)
Study Completion Date
August 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
EDGREM Investimentos
Collaborators
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ectopic Pregnancy is an entity in which a fertilized ovum is implanted outside its normal place, is considered a public health problem worldwide and is one of the main causes of maternal mortality in the first trimester. The availability of high sensitivity methods of detection of gonadotrophins and the use of high resolution transvaginal ultrasonography have allowed an earlier diagnosis of the same, enabling less aggressive treatments such as the use of parenteral MTX, with the intention of avoiding mutilating surgical treatment , preserving the tube and eventually improving future fertility expectations. The surgical treatment is of choice, this can be laparoscopically or by laparotomy. In this case, we need to preserve fertility, the most indicated is linear salpingostomy; In spite of the existence other techniques.
Detailed Description
The EP constitutes a frequent obstetric emergency in Angola and the province of Benguela is not exempt from this health problem. Every day we see women with this pathology, to which, most of them, they undergo a mutilating surgical treatment (salpingectomy) that impedes their future reproductive capacity. The procreation in the African continent and especially in Angola, has great social and family implications that can reach the breaking of marriages and family (broadcast and study of the Public Television of Angola in the program "Na lente" no year 2018 Taking into account the importance of procreation in the welfare and stability of the marital relationship.Main Objectiv: To demonstrate the non-inferiority of conservative treatment with MTX in ipsilateral tubal patency after an uncomplicated ectopic pregnancy compared with surgical treatment with linear salpingostomy in the Hospital General, Angola

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
Keywords
uncomplicated ectopic pregnancy methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial comparing ipsilateral tubal patency with the use of two therapeutic methods, groups A; with intramuscular methotrexate administration and B conservative surgery (linear salpingostomy)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical treatment
Arm Type
Active Comparator
Arm Description
By administering a single intramuscular dose of 50mg / m2 / Sc of Methotrexate.
Arm Title
Surgical treatment
Arm Type
Active Comparator
Arm Description
Will be performed by laparoscopy or laparotomy, using the Linear Salpingostomy technique.
Intervention Type
Drug
Intervention Name(s)
Medical treatment
Other Intervention Name(s)
Surgical treatment
Intervention Description
The surgical treatment group can be laparoscopically or by laparotomy, using the Linear Salpingostomy technique. Follow-up with β fraction of chorionic gonadotropin on days 0, 3, 7 and 14 together with gynecological abdominal or transvaginal ultrasound on day 0 and 7 and hysterosalpingography will be performed after three months of treatment.
Primary Outcome Measure Information:
Title
Incidence of Ipsilateral tubal patency
Description
Incidence of Ipsilateral tubal patency
Time Frame
A hysterosalpingography will be performed 3 months after the treatment.
Secondary Outcome Measure Information:
Title
Incidence of Achieve the gestation and the culmination.
Description
Incidence of Achieve the gestation and the culmination.
Time Frame
Up to two years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient presenting with Ectopic Pregnancy, associated with quantitative titers of βHCG ≥ 100 mUI / ml, without intrauterine gestational sac. Patient presenting uncomplicated Ectopic Pregnancy with an adnexal mass diameter ≤4 cm diagnosed by abdominal and / or transvaginal ultrasonography. Absence of heartbeat. No toxicity to MTX. Normal laboratory tests (blood count, coagulogram, liver and kidney function). Hemodynamic stability. Exclusion Criteria: Complicated Ectopic Pregnancy. Ectopic pregnancy is out of the tuba on ultrasound Patients with Immunosuppression. Allergy to MTX. Patients with Active Respiratory Disease, Blood Dyspasia, Peptic Ulcer, Renal Insufficiency and Hepatic Insufficiency. Do not accept to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIA DOLORES SABORIDO, MsC
Phone
+244926670289
Email
reguera@ywz.es
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Kedisobua
Phone
+244924951523
Email
drkedisobua@yahoo.com.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moreno Araujo
Organizational Affiliation
EDGREN INVESTIMENTOS
Official's Role
Study Chair
Facility Information:
Facility Name
Maria Dolores Reguera Saborido
City
Benguela
ZIP/Postal Code
999
Country
Angola
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moreno Araujo
Phone
+244926670289
Email
reguera@ywz.es
First Name & Middle Initial & Last Name & Degree
EDUARDO KEDISOBUA, UNIVERSITY

12. IPD Sharing Statement

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Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment.

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