Clinical trial NCT04894292: The Effect of Adenomoyosis on Pregnancy Outcomes
Official title: Adverse Obstetrical Outcomes for Women With Adenomyosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenomyosis
Pregnancy Complications
Keywords: adenomyosis
pregnancy complications
MUSA classification
ultrasound
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women diagnosed by TV usg before the 6th gestational week will be divided into two according to the MUSA classification, and those with adenomyosis who are not in the study group will be evaluated as the control group.

All the participants should be at between 18-35 age years old and all perinatal visits and deliveries should be at Tepecik Obstetric Clinic.

Brief summary: Adenomyosis can be defined as the settling of endometrial gland cells in the myometrium and deformity in the uterus and the prevalence of adenomyosis is according to the patient population and countries around 20%. There are recent publications reporting that this rate increases up to 50% in women dealing with infertility. In adenomyosis, where uterine morphology is affected, it is not thought that the uterus, which is expected to provide many morphological adaptations during pregnancy, will not be affected. Therefore, in this prospective study, it was planned to investigate the effects of adenomyosis during pregnancy.

For this study the presence of adenomyosis will be questioned by using ultrasonographic morphological uterine limitation (MUSA) in women who apply to the outpatient clinic with suspicion of pregnancy and undergo transvaginal ultrasonography for the diagnosis of pregnancy before sixth gestational week.

Patients will be divided into two groups according to the presence of adenomyosis and pregnancy complications such as preterm labor, premature rupture of membranes, cesarean section rates, preeclampsia, fetal malpresentation and preeclampsia will be compared between the groups.


Eligibility criteria: Inclusion Criteria:

* Age between 18-35 years
* Being diagnosed before the 6th gestational week
* Having all pregnancy follow-ups and deliveries in our hospital

Exclusion Criteria:

* Previous uterine surgery
* Multiple pregnancies
* Pregnant women with uterine malformations
* Pregnant women with fetal anomalies
* Those who got pregnant using assisted reproductive technique

Primary outcomes:
measure: Pregnancy complication
timeFrame: 15 month
Secondary outcomes:
measure: Pregnancy complication
timeFrame: 16 month
measure: Pregnancy complication
timeFrame: 17 month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Education and Research Hospital
Study officials:
affiliation: Tepecik Education and Research Hospital
name: Ahkam Göksel Kanmaz, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Harada T, Taniguchi F, Amano H, Kurozawa Y, Ideno Y, Hayashi K, Harada T; Japan Environment and Children's Study Group. Adverse obstetrical outcomes for women with endometriosis and adenomyosis: A large cohort of the Japan Environment and Children's Study. PLoS One. 2019 Aug 2;14(8):e0220256. doi: 10.1371/journal.pone.0220256. eCollection 2019.
citation: Horton J, Sterrenburg M, Lane S, Maheshwari A, Li TC, Cheong Y. Reproductive, obstetric, and perinatal outcomes of women with adenomyosis and endometriosis: a systematic review and meta-analysis. Hum Reprod Update. 2019 Sep 11;25(5):592-632. doi: 10.1093/humupd/dmz012.