Surgical Evacuation Versus Methotrexate Injection in Treatment of Caesarean Scar Pregnancy [Clinical Trial ]
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical evacuation and methotrexate injection.
- Who it may be relevant to
- Registry conditions: Caesarean Scar Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrasound Guided Surgical Evacuation Versus Combined Local and Systemic Methotrexate Injection for Management of Caesarean Scar Pregnancy [Clinical Trial ]
Overview
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.
Interventions
- Procedure Surgical evacuation and methotrexate injection
Surgical evacuation of the scar pregnancy using ultrasound and local and systemic methotrexate injection
Primary outcome measures
- Success rate of treatment either by surgical evacuation or by methotrexate injection [Time frame: Up to 8 weeks post -intervention]
Secondary outcome measures (6)
- Bleeding during the procedure [Time frame: Up to 8 weeks post -intervention]
- The need for additional intervention [Time frame: Up to 8 weeks post -intervention]
- Time for serum-hCG normalisation (days). [Time frame: Up to 8 weeks post -intervention]
- Hospital stay (days). [Time frame: Up to 8 weeks post -intervention]
- Uterine perforation. [Time frame: Up to 8 weeks post -intervention]
- Occurrence of drug complications [Time frame: Up to 8 weeks post -intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 24315547
Identifiers
NCT: NCT07288307 · CSP-MTX-01