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

Not Applicable

• Conditions: Menstruation; Cesarean Scar Pregnancy

• Registration Number: NCT03218059
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-03-12
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-14
• Last Update Posted: 2017-07-14
• Study Start: 2017-07-15
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Duration of menstruation by questionnaire	six months after treatment	Duration of menstruation
Endocrine level by blood examination	six months after treatment	FSH in IU/L
Volume of menstruation by questionnaire	six months after treatment	in pictorial blood loss score

Secondary Outcome Measures

Name	Time	Method
The length of the CSD by MRI	six months after treatment	millimeter
The depth of the CSD by MRI	six months after treatment	millimeter

Trial Locations

Locations (1)

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University; 🇨🇳 Shanghai, Shanghai, China