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

Menstruation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03218059
• Other study ID #: ShanghaiFMIH-CSP Treatment
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2017
• Last updated: July 12, 2017
• Start date: July 15, 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xipeng Wang
• Phone: 0086-13817806602
• Email: xipengwang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

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. 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.

Related Conditions & MeSH terms

• Cesarean Scar Pregnancy
• Menstruation

Intervention

Procedure:
• Methotrexate Combined With Transvaginal Surgery
The methods of treatment of CSP

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	Duration of menstruation	six months after treatment
Primary	Endocrine level by blood examination	FSH in IU/L	six months after treatment
Primary	Volume of menstruation by questionnaire	in pictorial blood loss score	six months after treatment
Secondary	The length of the CSD by MRI	millimeter	six months after treatment
Secondary	The depth of the CSD by MRI	millimeter	six months after treatment