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Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy

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ClinicalTrials.gov Identifier: NCT03218059
Recruitment Status : Not yet recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Shanghai First Maternity and Infant Hospital

Brief Summary:
Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D&C in the treatment of CSP.

Condition or disease Intervention/treatment Phase
Cesarean Scar Pregnancy Menstruation Procedure: Methotrexate Combined With Transvaginal Surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
Estimated Study Start Date : July 15, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation Scars


Intervention Details:
  • Procedure: Methotrexate Combined With Transvaginal Surgery
    The methods of treatment of CSP
    Other Name: Uterine Artery Embolization Combined With Uterine Curettage


Primary Outcome Measures :
  1. Duration of menstruation by questionnaire [ Time Frame: six months after treatment ]
    Duration of menstruation

  2. Endocrine level by blood examination [ Time Frame: six months after treatment ]
    FSH in IU/L

  3. Volume of menstruation by questionnaire [ Time Frame: six months after treatment ]
    in pictorial blood loss score


Secondary Outcome Measures :
  1. The length of the CSD by MRI [ Time Frame: six months after treatment ]
    millimeter

  2. The depth of the CSD by MRI [ Time Frame: six months after treatment ]
    millimeter



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion Criteria:

All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218059


Contacts
Contact: Xipeng Wang 0086-13817806602 xipengwang@hotmail.com
Contact: Huihui Chen 0086-13916278505 huihui78505@hotmail.com

Locations
China, Shanghai
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University Not yet recruiting
Shanghai, Shanghai, China, 201204
Contact: Xipeng Wang    0086-13817806602    xipengwang@hotmail.com   
Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital
Investigators
Study Chair: Xipeng Wang Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Responsible Party: Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT03218059     History of Changes
Other Study ID Numbers: ShanghaiFMIH-CSP Treatment
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai First Maternity and Infant Hospital:
Cesarean Scar Pregnancy

Additional relevant MeSH terms:
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors