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Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula

Primary Purpose

Cesarean Scar Diverticula

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GnRHa
Vaginal repair of CSD
Sponsored by
Xipeng Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Scar Diverticula focused on measuring cesarean scar diverticula, vaginal repair, GnRHa

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients are younger than 40.
  2. Clearly diagnosed with CSD.
  3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
  4. The thickness of the remaining muscular layer of CSD was less than 3 mm.
  5. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
  6. The medicine conservative treatment is invalid.
  7. Refusing or use birth control pills contraindications.
  8. No serious medical problems (important viscera function in the normal range).
  9. No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.
  10. No gynaecology or other malignant tumors.
  11. Sign the informed consent.

Exclusion Criteria:

  1. Over the age of 40;
  2. Indefinite diagnosis.
  3. The absence of clinical manifestations of CSD.
  4. The presence of menstrual irregularities before cesarean delivery.
  5. Coagulation disorders.
  6. Malignant tumors.
  7. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
  8. Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.
  9. Use of intrauterine devices.
  10. Unwilling to comply with the research plan.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VR + GnRHa

VR

Arm Description

CSD patients were treated with vaginal repair of CSD in combination with GnRHa (Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom) as a subcutaneous injection (abbreviated as VR + GnRHa). In the group of VR + GnRHa, 2 doses of GnRHa were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).

CSD patients were treated with vaginal repair of CSD in combination with 0.01 ml saline as a subcutaneous injection (abbreviated as VR). In the group of VR, 2 doses of saline were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).

Outcomes

Primary Outcome Measures

thickness of the remaining muscular layer (mm)
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
duration of menstruation (day)
The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.

Secondary Outcome Measures

the length of CSD (mm)
The length of CSD is measured by transvaginal ultrasound.
the width of CSD (mm)
The width of CSD is measured by transvaginal ultrasound.
the depth of CSD (mm)
The depth of CSD is measured by transvaginal ultrasound.

Full Information

First Posted
October 8, 2016
Last Updated
October 11, 2016
Sponsor
Xipeng Wang
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1. Study Identification

Unique Protocol Identification Number
NCT02932761
Brief Title
Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula
Official Title
Comparison of the Therapeutic Effects of Vaginal Repair and Vaginal Repair Combined With GnRHa in the Treatment of Cesarean Scar Diverticula: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xipeng Wang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. The investigators have previously demonstrated that vaginal repair of CSD was an relative effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months post vaginal repair. Postoperative menstruation may contribute to surgical site infections, which may subsequently affect the healing of uterine scars. Treatment CSD patients with gonadotropin-releasing hormone agonist (GnRHa) may has the potential to improve therapeutic effects of vaginal repair. Therefore, the current multiple-center randomized controlled trial was designed to evaluate whether the application of GnRHa in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
Detailed Description
Postoperative menstruation may contribute to surgical site infections, an inflammatory environment, congestion at the site of the suture, immune cell infiltration, and other effects and may subsequently affect the healing of uterine scars. It is reasonable to hypothesize that delaying the postoperative menstrual recovery period may allow uterine scars to heal without the inflammatory reaction caused by menstruation. Treatment with gonadotropin-releasing hormone agonist (GnRHa) has the ability to suppress follicle-stimulating hormone (FSH) and luteinizing hormone (LH) release, thereby maintaining low estrogen levels and causing temporary amenorrhea. A prolonged menstrual recovery period may be achieved after GnRHa administration. Vaginal repair of CSD combined with GnRHa may improve the therapeutic effects of treatment of CSD. Therefore, the randomized study was designed to evaluate whether the application of GnRHa in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Scar Diverticula
Keywords
cesarean scar diverticula, vaginal repair, GnRHa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR + GnRHa
Arm Type
Experimental
Arm Description
CSD patients were treated with vaginal repair of CSD in combination with GnRHa (Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom) as a subcutaneous injection (abbreviated as VR + GnRHa). In the group of VR + GnRHa, 2 doses of GnRHa were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).
Arm Title
VR
Arm Type
Placebo Comparator
Arm Description
CSD patients were treated with vaginal repair of CSD in combination with 0.01 ml saline as a subcutaneous injection (abbreviated as VR). In the group of VR, 2 doses of saline were administered. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure. The detailed procedure of VR has been described in our previous study (Zhou et al., 2016).
Intervention Type
Drug
Intervention Name(s)
GnRHa
Other Intervention Name(s)
Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom
Intervention Description
Two doses of GnRHa were administered by subcutaneous injection. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
Vaginal repair of CSD
Intervention Description
The procedure of vaginal repair of CSD was shown as following. The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached. The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed. A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.
Primary Outcome Measure Information:
Title
thickness of the remaining muscular layer (mm)
Description
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
Time Frame
6 months after vaginal repair of CSD
Title
duration of menstruation (day)
Description
The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.
Time Frame
6 months after vaginal repair of CSD
Secondary Outcome Measure Information:
Title
the length of CSD (mm)
Description
The length of CSD is measured by transvaginal ultrasound.
Time Frame
6 months after vaginal repair of CSD
Title
the width of CSD (mm)
Description
The width of CSD is measured by transvaginal ultrasound.
Time Frame
6 months after vaginal repair of CSD
Title
the depth of CSD (mm)
Description
The depth of CSD is measured by transvaginal ultrasound.
Time Frame
6 months after vaginal repair of CSD

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients are younger than 40. Clearly diagnosed with CSD. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days). The thickness of the remaining muscular layer of CSD was less than 3 mm. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation. The medicine conservative treatment is invalid. Refusing or use birth control pills contraindications. No serious medical problems (important viscera function in the normal range). No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts. No gynaecology or other malignant tumors. Sign the informed consent. Exclusion Criteria: Over the age of 40; Indefinite diagnosis. The absence of clinical manifestations of CSD. The presence of menstrual irregularities before cesarean delivery. Coagulation disorders. Malignant tumors. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section. Use of intrauterine devices. Unwilling to comply with the research plan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xipeng Wang, M.D., Ph.D.,
Phone
86-13817806602
Email
xipengwang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoqian Yang, M.D., Ph.D.,
Phone
86-18516703569
Email
yangxiaoqian1986@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xipeng Wang, M.D., Ph.D.,
Organizational Affiliation
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201204
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula

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