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

NCT ID: NCT02933190

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Magnetic Resonance Imaging Ovarian Function Menstruation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CSP;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

Group Type OTHER

transvaginal surgery;UAE and D&C

Intervention Type PROCEDURE

For cesarean scar pregnancy treatment

Interventions

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transvaginal surgery;UAE and D&C

For cesarean scar pregnancy treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xipeng Wang

Role: STUDY_CHAIR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xipeng Wang

Role: CONTACT

0086-13817806602

Huihui Chen

Role: CONTACT

0086-13916278505

Facility Contacts

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Xipeng Wang

Role: primary

86-13817806602

Other Identifiers

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ShanghaiFMIH-CSP

Identifier Type: -

Identifier Source: org_study_id

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