Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy

Magnetic Resonance Imaging Clinical Trial

Official title:

Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933190
• Other study ID #: ShanghaiFMIH-CSP
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: October 12, 2016
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xipeng Wang
• Phone: 0086-13817806602
• Email: xipengwang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial Summary

To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• increased levels of serum ß-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(24). 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Menstruation
• Ovarian Function

Intervention

Procedure:
• transvaginal surgery;UAE and D&C
For cesarean scar pregnancy treatment

Locations

Country	Name	City	State
China	Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of menstruation by questionnaire (days)		six months after treatment	No
Primary	Endocrine level by blood examination (FSH in IU/L)		six months after treatment	No
Primary	Volume of menstruation by questionnaire (in pictorial blood loss score)		six months after treatment	No
Secondary	The length of the CSD by MRI (millimeter)		six months after treatment	No
Secondary	The width of the CSD by MRI (millimeter)		six months after treatment	No
Secondary	The depth of the CSD by MRI (millimeter)		six months after treatment	No