Cesarean Scar PregnancyPhase 4NCT04379219
Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy
A Phase 4 study testing Methotrexate in people with Cesarean Scar Pregnancy, run by Mansoura University at 1 site in Egypt.
Trial summary
There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez \& Tulandi, 2017). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Scar Pregnancy
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age before 13 w
- Past history of 1 or more CS
- Presence of GS implanted on cesareans scar
Who cannot join
- Presence of severe vaginal bleeding (emergency)
- Previous history of uterine surgery other than CS
- The whole mass is interior and the bulge is more in the cavity
- Bleeding disorder
- Patient not candidate for methotrexate (Positive fetal heart pulsation,
- Patient refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahliya
Maher Elgaly, MD,MRCOG
About this study
Official title: Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial
There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez \& Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).
Read the detailed description
This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy
- Conditions
- Cesarean Scar Pregnancy
- Being tested
- Methotrexate
- Keywords
- cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy
- Medical subject headings
- Abortion, Spontaneous, Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called unitrexate
giving methotrexate at least 1 w week before surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | * Valid consent
* Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V )
* Laparotomy transverse incision (pfannenstiel incision)
* Exploration of the abdominal cavity
* Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass.
* Surgical repair of the uterine incision, and the abdomen Receives: Drug: Methotrexate |
| methotrexate before surgery | Active comparator | Valid consent
* patient will receive 50 mgm /m2 of methtrexate after full investigation ( CBC, serum creatinie, AlT, AST), 1 week before surgery.
* Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V )
* Laparotomy transverse incision (pfannenstiel incision)
* Exploration of the abdominal cavity
* Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass.
* Surgical repair of the uterine incision, and the abdomen Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss intraoperative
the amount of blood in soaked towels and vacuum aspiration
Measured: intraoperative blood loss
Secondary outcomes (3)
need further management
Measured: 1 month
• Rate of urological injury
Measured: immediatly and 1 week post operative
• Rate of readmission, relaparotomy
Measured: with in 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Dec 2019
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar PregnancyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maher elesawi kamel elesawi, Mansoura University
- Investigators
- Maher Elgaly, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379219
- Sponsor's protocol ID
- R.19.10.639.R1.R2.R3
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04379219
- Acronym / sponsor ID
- R.19.10.639.R1.R2.R3
- Conditions
- Cesarean Scar Pregnancy
- Keywords
- cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez \& Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).
Detailed description
This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Drug: Methotrexate* Valid consent * Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ) * Laparotomy transverse incision (pfannenstiel incision) * Exploration of the abdominal cavity * Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass. * Surgical repair of the uterine incision, and the abdomen |
| methotrexate before surgery | Active comparator | Drug: MethotrexateValid consent * patient will receive 50 mgm /m2 of methtrexate after full investigation ( CBC, serum creatinie, AlT, AST), 1 week before surgery. * Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ) * Laparotomy transverse incision (pfannenstiel incision) * Exploration of the abdominal cavity * Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass. * Surgical repair of the uterine incision, and the abdomen |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age before 13 w
- Past history of 1 or more CS
- Presence of GS implanted on cesareans scar
Key exclusion criteria (6 listed)
- Presence of severe vaginal bleeding (emergency)
- Previous history of uterine surgery other than CS
- The whole mass is interior and the bulge is more in the cavity
- Bleeding disorder
- Patient not candidate for methotrexate (Positive fetal heart pulsation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: unitrexategiving methotrexate at least 1 w week before surgery | Drug | methotrexate before surgery, surgery |
Primary outcome
Estimated blood loss intraoperative
Time frame: intraoperative blood loss
the amount of blood in soaked towels and vacuum aspiration
3 secondary outcomes
need further management
Time frame: 1 month
• Rate of urological injury
Time frame: immediatly and 1 week post operative
• Rate of readmission, relaparotomy
Time frame: with in 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Scar Pregnancy
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Effect of Methotrexate on Blood Loss During Laparoscopic Management of CS Scar Pregnancy
Cesarean Scar Pregnancy
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Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
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Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
Isthmocele, Cesarean Scar Diverticula
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Relation Between Type of Scar Pregnancy and Number of Previous Cesarean Sections
Scar Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maher Elgaly principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate in people with Cesarean Scar Pregnancy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maher Elesawi Elgaly, M.D MRCOG (+2 01016406182, mahereleswi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss intraoperative (time frame: intraoperative blood loss). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.