Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial
Introduction Recently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting,...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2021-08-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/8/e045770.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846136369967005696 |
|---|---|
| author | Ben W Mol Li Xie Yan Liang Li Yan Xiaoqing He Chenfeng Zhu Chuqing He Taotao Sun Xiaoya Zhao J.A.F Huirne |
| author_facet | Ben W Mol Li Xie Yan Liang Li Yan Xiaoqing He Chenfeng Zhu Chuqing He Taotao Sun Xiaoya Zhao J.A.F Huirne |
| author_sort | Ben W Mol |
| collection | DOAJ |
| description | Introduction Recently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting, it has not been studied if the effect of levonorgestrel 52 mg intrauterine system (LNG-IUS 52 mg) is superior to that of hysteroscopy. This study will answer the question of whether LNG-IUS 52 mg is more effective in improving postmenstrual spotting than hysteroscopic niche resection in women with niche-related spotting at 6 months after randomisation.Methods and analysis This is a randomised controlled trial. A total of 208 women with postmenstrual spotting related to niche in the caesarean uterine scar of at least 2 mm and residual myometrium of at least 2.2 mm evaluated by MRI will be included. Women desiring to conceive within 1 year, with contraindications for LNG-IUS 52 mg or hysteroscopic surgery will be excluded. After informed consent is obtained, eligible women will be randomly allocated to LNG-IUS 52 mg or hysteroscopic niche resection at 1:1. The primary outcome is the efficacy in reducing postmenstrual spotting at 6 months after randomisation. The secondary outcomes include menstrual pattern, total days of blood loss per month, rate of amenorrhoea, side effects and complications.We will use a Visual Analogue Scale for chronic pelvic pain, urological symptoms and women’s satisfaction (five-point Likert scale).Ethics and dissemination The study was approved by the local medical ethics committee and by the Institutional Review Board of the International Peace Maternity and Child Health Hospital, Shanghai, China (No. GKLW 2019-08). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.Trial registration number ChiCTR1900025677. |
| format | Article |
| id | doaj-art-1406a319110d48a0a8b9e2ad140f90cb |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-1406a319110d48a0a8b9e2ad140f90cb2024-12-09T05:45:09ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2020-045770Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trialBen W Mol0Li Xie1Yan Liang2Li Yan3Xiaoqing He4Chenfeng Zhu5Chuqing He6Taotao Sun7Xiaoya Zhao8J.A.F Huirne9Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, AustraliaClinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Cardiology, Maoming People`s Hospital, Guangdong, ChinaprofessorDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, ChinaShanghai Key Laboratory Embryo Original Diseases, Shanghai, ChinaMedical School of Nanjing University, Nanjing, Jiangsu Province, People’s Republic of ChinaDepartment of Obstetrics and Gynecology, Amsterdam Reproduction and Development Research institute, Amsterdam University Medical Centre, location AMC and VUmc, Amsterdam, NetherlandsIntroduction Recently, the rate of caesarean sections (CS) worldwide has risen and CS-associated complications such as niche have increased substantially. Until now, evidence-based clinical guidelines for the treatment of niche-related symptoms remain absent. In patients with postmenstrual spotting, it has not been studied if the effect of levonorgestrel 52 mg intrauterine system (LNG-IUS 52 mg) is superior to that of hysteroscopy. This study will answer the question of whether LNG-IUS 52 mg is more effective in improving postmenstrual spotting than hysteroscopic niche resection in women with niche-related spotting at 6 months after randomisation.Methods and analysis This is a randomised controlled trial. A total of 208 women with postmenstrual spotting related to niche in the caesarean uterine scar of at least 2 mm and residual myometrium of at least 2.2 mm evaluated by MRI will be included. Women desiring to conceive within 1 year, with contraindications for LNG-IUS 52 mg or hysteroscopic surgery will be excluded. After informed consent is obtained, eligible women will be randomly allocated to LNG-IUS 52 mg or hysteroscopic niche resection at 1:1. The primary outcome is the efficacy in reducing postmenstrual spotting at 6 months after randomisation. The secondary outcomes include menstrual pattern, total days of blood loss per month, rate of amenorrhoea, side effects and complications.We will use a Visual Analogue Scale for chronic pelvic pain, urological symptoms and women’s satisfaction (five-point Likert scale).Ethics and dissemination The study was approved by the local medical ethics committee and by the Institutional Review Board of the International Peace Maternity and Child Health Hospital, Shanghai, China (No. GKLW 2019-08). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.Trial registration number ChiCTR1900025677.https://bmjopen.bmj.com/content/11/8/e045770.full |
| spellingShingle | Ben W Mol Li Xie Yan Liang Li Yan Xiaoqing He Chenfeng Zhu Chuqing He Taotao Sun Xiaoya Zhao J.A.F Huirne Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial BMJ Open |
| title | Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial |
| title_full | Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial |
| title_fullStr | Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial |
| title_full_unstemmed | Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial |
| title_short | Comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar (MIHYS NICHE trial): protocol of a randomised controlled trial |
| title_sort | comparing levonorgestrel intrauterine system versus hysteroscopic resection in patients with postmenstrual spotting related to a niche in the caesarean scar mihys niche trial protocol of a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/11/8/e045770.full |
| work_keys_str_mv | AT benwmol comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT lixie comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT yanliang comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT liyan comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT xiaoqinghe comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT chenfengzhu comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT chuqinghe comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT taotaosun comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT xiaoyazhao comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial AT jafhuirne comparinglevonorgestrelintrauterinesystemversushysteroscopicresectioninpatientswithpostmenstrualspottingrelatedtoanicheinthecaesareanscarmihysnichetrialprotocolofarandomisedcontrolledtrial |