A niche is a defect that can develop at the site a caesarean section scar. A niche can cause complaints of abnormal uterine blood loss, dysmenorrhea, chronic pelvic pain and is related to infertility. Several innovative surgical therapies have been…
ID
Bron
Verkorte titel
Aandoening
- Niche
- Cesarean section scar defect
- Secondary subfertility
- Laparoscopy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Time to ongoing pregnancy, defined as a intrauterine pregnancy with a fetal heartrate at 12 weeks gestation.
Achtergrond van het onderzoek
A niche is a defect that can develop at the site a caesarean section scar. A niche can cause complaints of abnormal uterine blood loss, dysmenorrhea, chronic pelvic pain and is related to infertility. Several innovative surgical therapies have been developed to treat niche related symptoms. A laparoscopic resection of the niche is preferred in a large (residual myometrium ≤3mm) symptomatic niche. Reduction of symptoms and promising reproductive outcomes at a low complication rate have been reported in a few case series and cohort studies.
Objective of the study:
The aim of the study is to evaluate the effect of a laparoscopic niche resection in patients with secondary unexplained subfertility or failed IVF in comparison to expectant management on fertility, pregnancy outcome and postmenstrual spotting. Cost-effectiveness analysis will be executed alongside the study.
Doel van het onderzoek
A niche is a defect that can develop at the site a caesarean section scar. A niche can cause complaints of abnormal uterine blood loss, dysmenorrhea, chronic pelvic pain and is related to infertility. Several innovative surgical therapies have been developed to treat niche related symptoms. A laparoscopic resection of the niche is preferred in a large (residual myometrium <3mm) symptomatic niche. Reduction of symptoms and promising reproductive outcomes at a low complication rate have been reported in a few case series and cohort studies.
Onderzoeksopzet
- 3, 6, 12 months
- follow up during pregnancy
- follow-up: 2 years
Onderzoeksproduct en/of interventie
Laparoscopic niche resection, contraceptives during the first 6 months to enable healing of the uterine scar before a pregnancy is allowed, thereafter fertility therapies are allowed if needed, according to the local protocol.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Women (>18 years) with the presence of a large niche and secondary unexplained subfertility, failed IVF, or with problems during their fertility therapy, such as intrauterine accumulation of fluid and/ or difficulties during the introduction of the ET of IU catheter will be included.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Pregnancy, age < 18 years, contraindications for general anaesthesia, a (suspected) malignancy, uterine of cervical polyps, submucosal fibroids, atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, hydrosalphinx.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6350 |
| NTR-old | NTR6534 |
| CCMO | NL57660.029.16 |
| OMON | NL-OMON50195 |