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

Not Applicable

• Conditions: Magnetic Resonance Imaging; Ovarian Function; Menstruation
• Interventions: Procedure: transvaginal surgery；UAE and D&C

• Registration Number: NCT02933190
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-14
• Last Update Posted: 2016-10-14
• Study Start: 2016-11
• Primary Completion: 2018-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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(24). All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CSP；transvaginal surgery；UAE and D&C	transvaginal surgery；UAE and D&C	Cesarean scar pregnancy (CSP) refers to the implantation of a gestational sac with the myometrium at the site of a previous cesarean scar

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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