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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ectopic Pregnancy
• Intervention / Treatment: Drug: Medical treatment

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
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARIA DOLORES SABORIDO, MsC; Phone Number: +244926670289; Email: reguera@ywz.es
• Study Contact Backup: Name: Eduardo Kedisobua; Phone Number: +244924951523; Email: drkedisobua@yahoo.com.mx

Study Locations

• Angola
  • Benguela, Angola, 999
    • Recruiting
    • Maria Dolores Reguera Saborido
    • Contact: Moreno Araujo; Phone Number: +244926670289; Email: reguera@ywz.es
    • Principal Investigator: EDUARDO KEDISOBUA, UNIVERSITY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medical treatment; By administering a single intramuscular dose of 50mg / m2 / Sc of Methotrexate.	Drug: Medical treatment; 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.; Other Names: Surgical treatment
Active Comparator: Surgical treatment; Will be performed by laparoscopy or laparotomy, using the Linear Salpingostomy technique.	Drug: Medical treatment; 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.; Other Names: Surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Ipsilateral tubal patency	Incidence of Ipsilateral tubal patency	A hysterosalpingography will be performed 3 months after the treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Achieve the gestation and the culmination.	Incidence of Achieve the gestation and the culmination.	Up to two years

Collaborators and Investigators

• Sponsor: EDGREM Investimentos
• Collaborators: University of Alabama at Birmingham
• Investigators: Study Chair: Moreno Araujo, EDGREN INVESTIMENTOS

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Anticipated): August 17, 2022
• Study Completion (Anticipated): August 17, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: uncomplicated ectopic pregnancy methotrexate
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: EDINV-EENC

Drug and device information, study documents

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