The Effect of Adenomoyosis on Pregnancy Outcomes

NCT04894292 | Unknown DMC

• 1 other identifier: TepecikTRH-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenomyosis; Pregnancy Complications

Keywords

adenomyosis; pregnancy complications; MUSA classification; ultrasound

Outcome Measures

Primary Outcomes (1)

• Pregnancy complication

  Preterm labour

  15 month

Secondary Outcomes (2)

• Pregnancy complication

  16 month

• Pregnancy complication

  17 month

Study Arms (2)

Adenomyosis Group

Other: Non intervention

Non-adenomyosis Group

Other: Non intervention

Interventions

Non intervention OTHER

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

Adenomyosis Group; Non-adenomyosis Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Education and Research Hospital

Izmir, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 31374085 BACKGROUND

• 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.

  PMID: 31318420 BACKGROUND

MeSH Terms

Conditions

Adenomyosis; Pregnancy Complications

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahkam Göksel Kanmaz, Assoc. Prof.

  Tepecik Education and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Abdurrahman Hamdi İnan, Assoc. Prof.

CONTACT

(0232) 373 89 21; ahamdiinan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: May 20, 2021
• Study Start: May 20, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

TU (1)