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

NCT ID: NCT05136274

Last Updated: 2021-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2023-08-17

Brief Summary

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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

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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

Conditions

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Ectopic Pregnancy

Keywords

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uncomplicated ectopic pregnancy methotrexate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medical treatment

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

Group Type ACTIVE_COMPARATOR

Medical treatment

Intervention Type 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.

Surgical treatment

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

Group Type ACTIVE_COMPARATOR

Medical treatment

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Surgical treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

EDGREM Investimentos

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Kedisobua

Medical Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moreno Araujo

Role: STUDY_CHAIR

EDGREN INVESTIMENTOS

Locations

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Maria Dolores Reguera Saborido

Benguela, , Angola

Site Status RECRUITING

Countries

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Angola

Central Contacts

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MARIA DOLORES SABORIDO, MsC

Role: CONTACT

Phone: +244926670289

Email: [email protected]

Eduardo Kedisobua

Role: CONTACT

Phone: +244924951523

Email: [email protected]

Facility Contacts

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Moreno Araujo

Role: primary

Other Identifiers

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EDINV-EENC

Identifier Type: -

Identifier Source: org_study_id