No registrations found.
ID
Source
Brief title
Health condition
myomas (fibroids)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time until live birth
Secondary outcome
Live birth rate (birth AD> 24 weeks)
Premature birth
Miscarriage
Modus Partus
Complication of myomectomy
ART (assisted reproductive technology)
Background summary
Patients with asymptomatic myomas have a reduced risk of spontaneous pregnancy and an increased risk of premature birth and miscarriages. However, the extent of this effect is still insufficiently known, because the literature often does not include the type, number and localization of the myoma(s). Surgical treatment of myomas are frequently performed to treat gynecological complaints and/or improve pregnancy outcomes. The long-term outcomes of these interventions have not been sufficiently investigated with regard to the reproductive outcomes. These results are important for counseling patients considering such an intervention, but also for setting up a future (randomized) study.
The primary objective is to study pregnancy outcomes in patients with asymptomatic myomas without further interventions related to spontaneous pregnancy and an increased risk of premature birth and miscarriages. We want to see if number, localization, size, and type of myoma influences these outcomes. We want to investigate the same in women who have had a myoma treatment. We want to look both at women who have had surgical treatment on the myomas to promote fertility outcomes and also at women who received this from gynecological complaints.
Study objective
Surgical treatment of myomas can have a positive effect on the tome until ongoing pregnancy and decrease the risk of premature birth and miscarriages, but is depended on number, localization, size, and type of myoma.
Study design
One survey with questions about complaints, pregnancy and treatment of myomas.
Inclusion criteria
Patients that visited the VUmc, Amsterdam UMC, with myomas between 2004-2018.
Age at visitation between 18 and 45.
Exclusion criteria
Patients that visited the VUmc, Amsterdam UMC, with myomas before 2004 or after 2018.
Age at visitation between <18 or >45
Patients with intrauterine abnormalities of the uterine cavity other than myomas or endometrial polyps. Such as congenital uterine abnormalities, uterine septum, dominant adenomyosis, malignancies, dominant intrauterine adhesions/Asherman syndrome.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7990 |
| Other | MEC Amsterdam : protocol number 2019.225 |