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Caesarean Scar PregnancyPhase 2NCT07288307

Surgical Evacuation Versus Methotrexate Injection in Treatment of Caesarean Scar Pregnancy [Clinical Trial ]

A Phase 2 study testing Surgical evacuation and methotrexate injection in people with Caesarean Scar Pregnancy, run by Minia University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of the study is to compare the effectiveness and the complications of Ultrasound guided surgical evacuation versus using combined local and systemic methotrexate injection for management of caesarean scar pregnancy. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Caesarean Scar Pregnancy
What is being tested?
Surgical evacuation and methotrexate injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
20 Jan 2026to 1 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Gestation age Less than 12 weeks. Hemodynamically stable patient with un ruptured CSP. Non disturbed scar pregnancy . Acceptance of possible prolonged follow up, repeated HCG tests, the need for additional treatment doses and possible bleeding and subsequent hysterectomy.
  • -

Who cannot join

  • Patient refuse TOP. Gestation age More than 12 weeks . Hemodynamically unstable patient with ruptured CSP. Contraindication for methotrexate as hepatic disorders, renal disorders ,hypersensitivity to the drug and autoimmune diseases.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Badr Atef AbdAllah, MD contact

+201092975253

dr.badratef@gmail.com

About this study

Official title: Ultrasound Guided Surgical Evacuation Versus Combined Local and Systemic Methotrexate Injection for Management of Caesarean Scar Pregnancy [Clinical Trial ]

The aim of the study is to compare the effectiveness and the complications of Ultrasound guided surgical evacuation versus using combined local and systemic methotrexate injection for management of caesarean scar pregnancy.

Being tested
Surgical evacuation and methotrexate injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical evacuation and methotrexate injectionProcedure or surgery

    Surgical evacuation of the scar pregnancy using ultrasound and local and systemic methotrexate injection

Study groups in NCT07288307
Study groupRoleWhat they receive
Ultrasound surgical evacuationExperimentalNot described
Receives: Procedure: Surgical evacuation and methotrexate injection
Local and systemic methotrexate injectionActive comparatorNot described
Receives: Procedure: Surgical evacuation and methotrexate injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of treatment either by surgical evacuation or by methotrexate injection

    The proportion of participants achieving complete resolution of caesarean scar pregnancy without the need of additional intervention

    Measured: Up to 8 weeks post -intervention

Secondary outcomes (6)

  1. Bleeding during the procedure

    Measured: Up to 8 weeks post -intervention

  2. The need for additional intervention

    Measured: Up to 8 weeks post -intervention

  3. Time for serum-hCG normalisation (days).

    Measured: Up to 8 weeks post -intervention

  4. Hospital stay (days).

    Measured: Up to 8 weeks post -intervention

  5. Uterine perforation.

    Measured: Up to 8 weeks post -intervention

  6. Occurrence of drug complications

    Measured: Up to 8 weeks post -intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start20 Jan 2026 (estimated)
  3. Primary completion20 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288307
Sponsor's protocol ID
CSP-MTX-01
Status last verified
Dec 2025
First submitted
15 Dec 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Larsen JV, Solomon MH. Pregnancy in a uterine scar sacculus--an unusual cause of postabortal haemorrhage. A case report. S Afr Med J. 1978 Jan 28;53(4):142-3.

    PubMed 653492

  • Seow KM, Huang LW, Lin YH, Lin MY, Tsai YL, Hwang JL. Cesarean scar pregnancy: issues in management. Ultrasound Obstet Gynecol. 2004 Mar;23(3):247-53. doi: 10.1002/uog.974.

    PubMed 15027012

  • Jurkovic D, Hillaby K, Woelfer B, Lawrence A, Salim R, Elson CJ. First-trimester diagnosis and management of pregnancies implanted into the lower uterine segment Cesarean section scar. Ultrasound Obstet Gynecol. 2003 Mar;21(3):220-7. doi: 10.1002/uog.56.

    PubMed 12666214

  • Rotas MA, Haberman S, Levgur M. Cesarean scar ectopic pregnancies: etiology, diagnosis, and management. Obstet Gynecol. 2006 Jun;107(6):1373-81. doi: 10.1097/01.AOG.0000218690.24494.ce.

    PubMed 16738166

  • Qian ZD, Guo QY, Huang LL. Identifying risk factors for recurrent cesarean scar pregnancy: a case-control study. Fertil Steril. 2014 Jul;102(1):129-134.e1. doi: 10.1016/j.fertnstert.2014.04.003. Epub 2014 May 10.

    PubMed 24825421

  • Maymon R, Halperin R, Mendlovic S, Schneider D, Herman A. Ectopic pregnancies in a Caesarean scar: review of the medical approach to an iatrogenic complication. Hum Reprod Update. 2004 Nov-Dec;10(6):515-23. doi: 10.1093/humupd/dmh042. Epub 2004 Sep 16.

    PubMed 15375087

  • Yang MJ, Jeng MH. Combination of transarterial embolization of uterine arteries and conservative surgical treatment for pregnancy in a cesarean section scar. A report of 3 cases. J Reprod Med. 2003 Mar;48(3):213-6.

    PubMed 12698784

  • Peng KW, Lei Z, Xiao TH, Jia FG, Zhong WX, Gao Y, Shen BX, Xie JW. First trimester caesarean scar ectopic pregnancy evaluation using MRI. Clin Radiol. 2014 Feb;69(2):123-9. doi: 10.1016/j.crad.2013.07.021. Epub 2013 Dec 6.

    PubMed 24315547

  • Vial Y, Petignat P, Hohlfeld P. Pregnancy in a cesarean scar. Ultrasound Obstet Gynecol. 2000 Nov;16(6):592-3. doi: 10.1046/j.1469-0705.2000.00300-2.x. No abstract available.

    PubMed 11169360

  • Weimin W, Wenqing L. Effect of early pregnancy on a previous lower segment cesarean section scar. Int J Gynaecol Obstet. 2002 Jun;77(3):201-7. doi: 10.1016/s0020-7292(02)00018-8.

    PubMed 12065130

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgical evacuation and methotrexate injection in people with Caesarean Scar Pregnancy, run by Minia University.

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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Badr Atef AbdAllah, MD (+201092975253, dr.badratef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of treatment either by surgical evacuation or by methotrexate injection (time frame: Up to 8 weeks post -intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288307, which also lists 10 linked publications.

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 17 Dec 2025.

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