Perinatal Consequences of Endometriosis
Kľúčové slová
Abstrakt
Popis
Design selected and justification: the study ENDOBST is a
- exposed / unexposed type
- in superiority
- with two comparative groups (endometriosis / without endometriosis)
- Ratio of distribution of subjects in study groups = 1: 2
ENDOBST is a comparative prospective multicenter study presentation exposed - unexposed type. The study aims to compare the outcomes of pregnancy in the whole exposed group to controls and then according to the three disease phenotype (superficial, ovarian, and deep endometriosis).
Endobst aims to test the hypothesis that women with endometriosis have an increased risk of preterm delivery (primary endpoint) and an increased risk of pregnancy complications (secondary endpoints) when compared to diseases-free women. Comparisons will be performed according to disease phenotype.
These analyzes will be conducted after taking into account factors likely to influence the occurrence of preterm birth such as particularly social characteristics (education level, employment status), age and body mass index of women, pathological medical and obstetrical history and behavioral factors (tobacco).
Secondary analyzes will be conducted to investigate the link between endometriosis, and other adverse pregnancy outcomes (premature rupture of membranes, intrauterine growth restriction), complications related to the surgical treatment endometriosis prior to pregnancy.
Regarding the previous surgical treatment, the subgroup of women operated for their endometriosis will be compared to the subgroup of non-operated endometriosis in women and free subset of women. Particular attention will be paid to the phenotype of endometriosis and the nature of previous surgical treatment for pregnancy to control bias indication inherent in observational studies. These associations will be studied from multivariate regression models.
Termíny
| Naposledy overené: | 07/31/2018 |
| Prvý príspevok: | 07/12/2015 |
| Odhadovaná registrácia bola odoslaná: | 07/13/2015 |
| Prvý príspevok: | 07/14/2015 |
| Posledná aktualizácia bola odoslaná: | 08/26/2018 |
| Posledná aktualizácia bola zverejnená: | 08/27/2018 |
| Aktuálny dátum začatia štúdie: | 02/03/2016 |
| Odhadovaný dátum dokončenia primárneho okruhu: | 08/31/2019 |
| Odhadovaný dátum dokončenia štúdie: | 09/30/2020 |
Stav alebo choroba
Intervencia / liečba
Biological: Biological collection
Fáza
Skupiny zbraní
| Arm | Intervencia / liečba |
|---|---|
| Experimental: Type exposed endometriosis | |
| Experimental: Type unexposed Without endometriosis |
Kritériá oprávnenosti
| Vek vhodný na štúdium | 18 Years To 18 Years |
| Pohlavia vhodné na štúdium | Female |
| Prijíma zdravých dobrovoľníkov | Áno |
| Kritériá | Inclusion Criteria: - Patient major - Single Pregnancy - Patient followed before 22 SA and giving birth in the maternity ward in the study - Affiliated to health care Exclusion Criteria: - Opposition to the use of personal medical data or medical data of their child for research purposes - Pregnant women with multiple pregnancies - HIV positive women - Patients addressed in the center as part of a transfer in utero. - Women whose pregnancy is complicated by a spontaneous miscarriage before 15 weeks |
Výsledok
Primárne výstupné opatrenia
1. Number of preterm delivery [at Day 0 until 26 weeks]
Opatrenia sekundárnych výsledkov
1. premature rupture of membranes [at Day 0 until 26 weeks]
2. fetal loss [at Day 0 until 11 weeks]
3. intrauterine growth restriction [at Day 0 until 31 weeks]
4. induced or spontaneous preterm birth [at Day 0 until 26 weeks]
5. preeclampsia [at Day 0 until 31 weeks]
6. placenta previa [at Day 0 until 31 weeks]
7. postpartum hemorrhage [at 11 weeks until 31 weeks]
8. number of caesarean [at 11 weeks until 31 weeks]
