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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

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:

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.

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

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

NCT ID

NCT02932761

First Posted

October 8, 2016

Last Updated

October 11, 2016

Sponsor

Xipeng Wang

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

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

xipengwang@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoqian Yang, M.D., Ph.D.,

Phone

86-18516703569

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

Learn more about this trial

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

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