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

Ectopic Pregnancy Clinical Trial

— EENCBE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05136274
• Other study ID #: EDINV-EENC
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: August 17, 2023

Study information

• Verified date: November 2021
• Source: EDGREM Investimentos
• Contact: MARIA DOLORES SABORIDO, MsC
• Phone: +244926670289
• Email: reguera[@]ywz.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: August 17, 2023
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

Patient presenting with Ectopic Pregnancy, associated with quantitative titers of ßHCG = 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.

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Drug:
• Medical treatment
The surgical treatment group can be laparoscopically or by laparotomy, using the Linear Salpingostomy technique. Follow-up with ß 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.

Locations

Country	Name	City	State
Angola	Maria Dolores Reguera Saborido	Benguela

Sponsors (2)

Lead Sponsor	Collaborator
EDGREM Investimentos	University of Alabama at Birmingham

Country where clinical trial is conducted

Angola, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Ipsilateral tubal patency	Incidence of Ipsilateral tubal patency	A hysterosalpingography will be performed 3 months after the treatment.
Secondary	Incidence of Achieve the gestation and the culmination.	Incidence of Achieve the gestation and the culmination.	Up to two years