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

NCT07288307 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CSP-MTX-01
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Caesarean Scar Pregnancy

Outcome Measures

Primary Outcomes (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

  Up to 8 weeks post -intervention

Secondary Outcomes (6)

• Bleeding during the procedure

  Up to 8 weeks post -intervention

• The need for additional intervention

  Up to 8 weeks post -intervention

• Time for serum-hCG normalisation (days).

  Up to 8 weeks post -intervention

• Hospital stay (days).

  Up to 8 weeks post -intervention

• Uterine perforation.

  Up to 8 weeks post -intervention

Study Arms (2)

Ultrasound surgical evacuation

EXPERIMENTAL

Procedure: Surgical evacuation and methotrexate injection

Local and systemic methotrexate injection

ACTIVE COMPARATOR

Procedure: Surgical evacuation and methotrexate injection

Interventions

Surgical evacuation and methotrexate injection PROCEDURE

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

Local and systemic methotrexate injection; Ultrasound surgical evacuation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Related Publications (10)

• 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.

  PMID: 653492 BACKGROUND

• 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.

  PMID: 15027012 BACKGROUND

• 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.

  PMID: 12666214 BACKGROUND

• 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.

  PMID: 16738166 BACKGROUND

• 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.

  PMID: 24825421 BACKGROUND

• 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.

  PMID: 15375087 BACKGROUND

• 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.

  PMID: 12698784 BACKGROUND

• 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.

  PMID: 24315547 BACKGROUND

• 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.

  PMID: 11169360 BACKGROUND

• 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.

  PMID: 12065130 BACKGROUND

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Badr Atef AbdAllah, MD

CONTACT

+201092975253; dr.badratef@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Badr Atef

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 17, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12