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

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Brief Title

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

Official Title

Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment in Uncomplicated Ectopic Pregnancy, "Hospital General", Angola 2021-2022

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
    


Study Type

Interventional


Primary Outcome

Incidence of Ipsilateral tubal patency

Secondary Outcome

 Incidence of Achieve the gestation and the culmination.

Condition

Ectopic Pregnancy

Intervention

Medical treatment

Study Arms / Comparison Groups

 Medical treatment
Description:  By administering a single intramuscular dose of 50mg / m2 / Sc of Methotrexate.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

204

Start Date

August 17, 2021

Completion Date

August 17, 2023

Primary Completion Date

August 17, 2022

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.
      

Gender

Female

Ages

18 Years - 35 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Moreno Araujo, +244926670289, [email protected]

Location Countries

Angola

Location Countries

Angola

Administrative Informations


NCT ID

NCT05136274

Organization ID

EDINV-EENC


Responsible Party

Principal Investigator

Study Sponsor

EDGREM Investimentos

Collaborators

 University of Alabama at Birmingham

Study Sponsor

Moreno Araujo, Study Chair, EDGREN INVESTIMENTOS


Verification Date

November 2021