Evaluation of Ipsilateral Tubal Patency After Conservativ... | NCT05136274

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

NCT05136274

Sponsor

EDGREM Investimentos

Status

Unknown status

Last Update Posted

Nov 29, 2021Actual

Enrollment

204Estimated

Phase

Not Applicable

Conditions

Ectopic Pregnancy

Interventions

Medical treatment

Countries

Angola

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 17, 2021Actual

Primary Completion Date

Aug 17, 2022Estimated

Completion Date

Aug 17, 2023Estimated

First Submitted Date

Nov 8, 2021

First Submission Date that Met QC Criteria

Nov 24, 2021

First Posted Date

Nov 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2021

Last Update Posted Date

Nov 29, 2021Actual

Name	Class
University of Alabama at Birmingham	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MARIA DOLORES SABORIDO, MsC	Contact	+244926670289		reguera@ywz.es
Eduardo Kedisobua	Contact	+244924951523		drkedisobua@yahoo.com.mx

Overall Officials

Name	Affiliation	Role
Moreno Araujo	EDGREN INVESTIMENTOS	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maria Dolores Reguera Saborido	Recruiting	Benguela		999	Angola

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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)