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

NCT05136274 | Unknown DMC

• 1 other identifier: EDINV-EENC
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Ectopic Pregnancy

Keywords

uncomplicated ectopic pregnancy methotrexate

Outcome Measures

Primary Outcomes (1)

• Incidence of Ipsilateral tubal patency

  Incidence of Ipsilateral tubal patency

  A hysterosalpingography will be performed 3 months after the treatment.

Secondary Outcomes (1)

• Incidence of Achieve the gestation and the culmination.

  Up to two years

Study Arms (2)

Medical treatment

ACTIVE COMPARATOR

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

Drug: Medical treatment

Surgical treatment

ACTIVE COMPARATOR

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

Drug: Medical treatment

Interventions

Medical treatment DRUG

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.

Also known as: Surgical treatment

Medical treatment; Surgical treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EDGREM Investimentos: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

Maria Dolores Reguera Saborido

Benguela, 999, Angola

RECRUITING

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Moreno Araujo

  EDGREN INVESTIMENTOS

  STUDY CHAIR

Central Study Contacts

MARIA DOLORES SABORIDO, MsC

CONTACT

+244926670289; reguera@ywz.es

Eduardo Kedisobua

CONTACT

+244924951523; drkedisobua@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Surgery

Model Details: 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)

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 29, 2021
• Study Start: August 17, 2021
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2023
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

AN (1)