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

NCT02932761 | Unknown DMC

• 1 other identifier: CSD-001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Scar Diverticula

Keywords

cesarean scar diverticula; vaginal repair; GnRHa

Outcome Measures

Primary Outcomes (2)

• thickness of the remaining muscular layer (mm)

  The thickness of the remaining muscular layer is measured by transvaginal ultrasound.

  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.

  6 months after vaginal repair of CSD

Secondary Outcomes (3)

• the length of CSD (mm)

  6 months after vaginal repair of CSD

• the width of CSD (mm)

  6 months after vaginal repair of CSD

• the depth of CSD (mm)

  6 months after vaginal repair of CSD

Study Arms (2)

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).

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).

Procedure: Vaginal repair of CSD

Interventions

GnRHa DRUG

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.

Also known as: Zoladex, 3.6 mg, AstraZeneca, Macclesfield, United Kingdom

VR + GnRHa

Vaginal repair of CSD PROCEDURE

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.

VR; VR + GnRHa

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xipeng Wang: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201204, China

Location

MeSH Terms

Interventions

Goserelin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Xipeng Wang, M.D., Ph.D.,

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

  STUDY CHAIR

Central Study Contacts

Xipeng Wang, M.D., Ph.D.,

CONTACT

86-13817806602; xipengwang@hotmail.com

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

CONTACT

86-18516703569; yangxiaoqian1986@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 13, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)