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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Caesarean Scar Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound surgical evacuation

Group Type EXPERIMENTAL

Surgical evacuation and methotrexate injection

Intervention Type PROCEDURE

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

Local and systemic methotrexate injection

Group Type ACTIVE_COMPARATOR

Surgical evacuation and methotrexate injection

Intervention Type PROCEDURE

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

Interventions

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Surgical evacuation and methotrexate injection

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

\-

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Badr Atef Abd Allah Moussa

Badr Atef

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Badr Atef AbdAllah, MD

Role: CONTACT

Phone: +201092975253

Email: [email protected]

References

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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.

Reference Type BACKGROUND

PMID: 653492 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15027012 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12666214 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16738166 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 24825421 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15375087 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12698784 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 24315547 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11169360 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12065130 (View on PubMed)

Other Identifiers

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CSP-MTX-01

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Ultrasound surgical evacuation

Surgical evacuation and methotrexate injection

Local and systemic methotrexate injection

Surgical evacuation and methotrexate injection

Interventions

Surgical evacuation and methotrexate injection

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Minia University

Responsible Party

Badr Atef Abd Allah Moussa

Central Contacts

Badr Atef AbdAllah, MD

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Other Identifiers

CSP-MTX-01