- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932761
Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula
October 11, 2016 updated by: Xipeng Wang
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xipeng Wang, M.D., Ph.D.,
- Phone Number: 86-13817806602
- Email: xipengwang@hotmail.com
Study Contact Backup
- Name: Xiaoqian Yang, M.D., Ph.D.,
- Phone Number: 86-18516703569
- Email: yangxiaoqian1986@126.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 201204
- Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR + GnRHa
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).
|
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.
Other Names:
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.
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Placebo Comparator: VR
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
thickness of the remaining muscular layer (mm)
Time Frame: 6 months after vaginal repair of CSD
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The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
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6 months after vaginal repair of CSD
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duration of menstruation (day)
Time Frame: 6 months after vaginal repair of CSD
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The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.
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6 months after vaginal repair of CSD
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the length of CSD (mm)
Time Frame: 6 months after vaginal repair of CSD
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The length of CSD is measured by transvaginal ultrasound.
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6 months after vaginal repair of CSD
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the width of CSD (mm)
Time Frame: 6 months after vaginal repair of CSD
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The width of CSD is measured by transvaginal ultrasound.
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6 months after vaginal repair of CSD
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the depth of CSD (mm)
Time Frame: 6 months after vaginal repair of CSD
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The depth of CSD is measured by transvaginal ultrasound.
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6 months after vaginal repair of CSD
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Xipeng Wang, M.D., Ph.D.,, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Anticipated)
January 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
October 8, 2016
First Submitted That Met QC Criteria
October 11, 2016
First Posted (Estimate)
October 13, 2016
Study Record Updates
Last Update Posted (Estimate)
October 13, 2016
Last Update Submitted That Met QC Criteria
October 11, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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