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

NCT02933190 | Unknown

• 1 other identifier: ShanghaiFMIH-CSP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Magnetic Resonance Imaging; Ovarian Function; Menstruation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The length of the CSD by MRI (millimeter)

  six months after treatment

• The width of the CSD by MRI (millimeter)

  six months after treatment

• The depth of the CSD by MRI (millimeter)

  six months after treatment

Study Arms (1)

CSP；transvaginal surgery；UAE and D&C

OTHER

Cesarean scar pregnancy (CSP) refers to the implantation of a gestational sac with the myometrium at the site of a previous cesarean scar

Procedure: transvaginal surgery；UAE and D&C

Interventions

transvaginal surgery；UAE and D&C PROCEDURE

For cesarean scar pregnancy treatment

CSP；transvaginal surgery；UAE and D&C

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Shanghai, Shanghai Municipality, 201204, China

Location

MeSH Terms

Interventions

Dilatation and Curettage

Intervention Hierarchy (Ancestors)

Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Xipeng Wang

  Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

  STUDY CHAIR

Central Study Contacts

Xipeng Wang

CONTACT

0086-13817806602; xipengwang@hotmail.com

Huihui Chen

CONTACT

0086-13916278505; huihui78505@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: October 14, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2019
• Last Updated: October 14, 2016

Record last verified: 2016-08

Locations

CN (1)