The Effect of Adenomoyosis on Pregnancy Outcomes

NCT ID: NCT04894292

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adenomyosis Pregnancy Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adenomyosis Group

Non intervention

Intervention Type OTHER

During the study there is no extra intervention planned for the participants.

Non-adenomyosis Group

Non intervention

Intervention Type OTHER

During the study there is no extra intervention planned for the participants.

Interventions

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Non intervention

During the study there is no extra intervention planned for the participants.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tepecik Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahkam Göksel Kanmaz

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahkam Göksel Kanmaz, Assoc. Prof.

Role: STUDY_DIRECTOR

Tepecik Education and Research Hospital

Locations

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Tepecik Education and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Abdurrahman Hamdi İnan, Assoc. Prof.

Role: CONTACT

(0232) 373 89 21

Facility Contacts

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Göksel Kanmaz, Assoc. Prof.

Role: primary

+905308205483

References

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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.

Reference Type BACKGROUND
PMID: 31374085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31318420 (View on PubMed)

Other Identifiers

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TepecikTRH-001

Identifier Type: -

Identifier Source: org_study_id

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