Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201908880678351 Date of Registration: 02/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of ipsilateral tubal patency after conservative medical or surgical treatment in uncomplicated ectopic pregnancy
Official scientific title Evaluation of ipsilateral tubal patency after conservative medical or surgical treatment in uncomplicated ectopic pregnancy, "Hospital Geral de Benguela", Angola 2019-2020
Brief summary describing the background and objectives of the trial Ectopic Pregnancy (EP) 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 (1 - 4). 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 (3). 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 (1 , TPA na lente) 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 Geral Benguela, Angola 2019-2020.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GEUANGOLA
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 15/04/2019
Actual trial start date
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 204
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Medical treatment By administering a single intramuscular dose of 50mg / m2 / Sc of Methotrexate. 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 at three months after treatment. The medical treatment group will be formed by administering a single intramuscular dose of 50 mg / m2 / Sc of Methotrexate. The chorionic gonadotropin fraction was followed up on days 0, 3, 7 and 14, and abdominal or transvaginal gynecological ultrasound was performed on day 0 and 7 and hysterosalpingography was performed three months after treatment. 102 Active-Treatment of Control Group
Experimental Group Surgical treatment Will be performed by laparoscopy or 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. 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. 102
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● 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. ● 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. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 13 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/02/2019 National Institute of Public Health
Ethics Committee Address
Street address City Postal code Country
Luanda Luanda 9999 Angola
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ipsilateral tubal patency A hysterosalpingografy will be performed 3 months after the treatment.
Secondary Outcome Achieve the gestation and the culmination. Up to two years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Geral de Benguela 31 de Janeiro Benguela Angola
FUNDING SOURCES
Name of source Street address City Postal code Country
Eduardo Kedisobua Rua 31 Janeiro Bemguela 9999 Angola
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health Ministry Benguela Bengyela Angola Hospital
COLLABORATORS
Name Street address City Postal code Country
Wilfredo Gomez Flaquet Benguela Benguela Angola
Juan Carlos Solozabal Benguela Benguela Angola
Agustin Morejon Carralero Luanda Luanda Angola
Antonio Gil Moreno UAB Barcelona Spain
Carlota Rodo Rodriguez UAB BARCELONA Spain
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eduardo Kedisobua drkedisobua@yahoo.com.mx +244924951523 Rua 31 de Janeiro
City Postal code Country Position/Affiliation
Benguela Angola GENERAL SURGERY
Role Name Email Phone Street address
Public Enquiries Carlota Rodo Rodriguez crodo@vhebron.net +34659389938 UAB
City Postal code Country Position/Affiliation
BARCELONA Spain Gynecologist
Role Name Email Phone Street address
Scientific Enquiries Antonio Gil Moreno agil@vhebron.net +34659389938 UAB
City Postal code Country Position/Affiliation
BARCELONA Spain Gynecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Every date available: Ectopic pregnancy: (Y/N) Conservative medical or conservation surgical treatment Informed Consent Form,Statistical Analysis Plan,Study Protocol November until the end of study Web access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.hospitalgeraldebenguela.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information