Cesarean Scar DiverticulaNCT02932761
Comparison of the Therapeutic Effects of VR and VR + GnRHa in the Treatment of Cesarean Scar Diverticula
A study testing GnRHa and Vaginal repair of CSD in people with Cesarean Scar Diverticula, run by Xipeng Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Scar Diverticula
- What is being tested?
- GnRHa and Vaginal repair of CSD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, Shanghai Municipality, 201204
About this study
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
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.
Read the 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.
- Conditions
- Cesarean Scar Diverticula
- Being tested
- GnRHa, Vaginal repair of CSD
- Keywords
- cesarean scar diverticula, vaginal repair, GnRHa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRHaDrug
Also called Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom
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.
Vaginal repair of CSDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| VR + GnRHa | Experimental | 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). Receives: Drug: GnRHa; Procedure: Vaginal repair of CSD |
| VR | Placebo comparator | 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). Receives: Procedure: Vaginal repair of CSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of the remaining muscular layer (mm)
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
Measured: 6 months after vaginal repair of CSD
duration of menstruation (day)
The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.
Measured: 6 months after vaginal repair of CSD
Secondary outcomes (3)
the length of CSD (mm)
The length of CSD is measured by transvaginal ultrasound.
Measured: 6 months after vaginal repair of CSD
the width of CSD (mm)
The width of CSD is measured by transvaginal ultrasound.
Measured: 6 months after vaginal repair of CSD
the depth of CSD (mm)
The depth of CSD is measured by transvaginal ultrasound.
Measured: 6 months after vaginal repair of CSD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Scar DiverticulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xipeng Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xipeng Wang, Shanghai First Maternity and Infant Hospital
- Investigators
- Xipeng Wang, M.D., Ph.D.,, Study chair, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932761
- Sponsor's protocol ID
- CSD-001
- Status last verified
- Oct 2016
- First submitted
- 8 Oct 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen H, Yao M, Gao Z, Yang X, Wang Y, Wang X. Outcomes of Vaginal Repair and Vaginal Repair Combined With GnRHa Administration in the Treatment of Cesarean Section Scar Defects: A Randomized Clinical Trial. J Minim Invasive Gynecol. 2024 Sep;31(9):787-794.e1. doi: 10.1016/j.jmig.2024.05.023. Epub 2024 May 27.
PubMed 38810836
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02932761
- Acronym / sponsor ID
- CSD-001
- Conditions
- Cesarean Scar Diverticula
- Keywords
- cesarean scar diverticula, vaginal repair, GnRHa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xipeng WangUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR + GnRHa | Experimental | Drug: GnRHa, Procedure: Vaginal repair of CSDCSD 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). |
| VR | Placebo comparator | Procedure: Vaginal repair of CSDCSD 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). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- Over the age of 40;
- Indefinite diagnosis.
- The absence of clinical manifestations of CSD.
- The presence of menstrual irregularities before cesarean delivery.
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GnRHaAlso: Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United KingdomTwo 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. | Drug | VR + GnRHa |
| Vaginal repair of CSDThe 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. | Procedure or surgery | VR, VR + GnRHa |
Primary outcome
thickness of the remaining muscular layer (mm)
Time frame: 6 months after vaginal repair of CSD
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
duration of menstruation (day)
Time frame: 6 months after vaginal repair of CSD
The menstruation duration in CSD patients is collected 6 months after vaginal repair of CSD.
3 secondary outcomes
the length of CSD (mm)
Time frame: 6 months after vaginal repair of CSD
the width of CSD (mm)
Time frame: 6 months after vaginal repair of CSD
the depth of CSD (mm)
Time frame: 6 months after vaginal repair of CSD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 38810836Chen H, Yao M, Gao Z, Yang X, Wang Y, Wang X. Outcomes of Vaginal Repair and Vaginal Repair Combined With GnRHa Administration in the Treatment of Cesarean Section Scar Defects: A Randomized Clinical Trial. J Minim Invasive Gynecol. 2024 Sep;31(9):787-794.e1. doi: 10.1016/j.jmig.2024.05.023. Epub 2024 May 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xipeng Wang, M.D., Ph.D., study chair
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRHa and Vaginal repair of CSD in people with Cesarean Scar Diverticula, run by Xipeng Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xipeng Wang, M.D., Ph.D., (86-13817806602, xipengwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of the remaining muscular layer (mm) (time frame: 6 months after vaginal repair of CSD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.