The Effect of Adenomoyosis on Pregnancy Outcomes

Pregnancy Complications Clinical Trial

Official title:

Adverse Obstetrical Outcomes for Women With Adenomyosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04894292
• Other study ID #: TepecikTRH-001
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: Tepecik Training and Research Hospital
• Contact: Abdurrahman Hamdi Inan, Assoc. Prof.
• Phone: (0232) 373 89 21
• Email: ahamdiinan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Pregnancy Complications

Intervention

Other:
• Non intervention
During the study there is no extra intervention planned for the participants.

Locations

Country	Name	City	State
Turkey	Tepecik Education and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy complication	Preterm labour	15 month
Secondary	Pregnancy complication	placental anomalies	16 month
Secondary	Pregnancy complication	preeclampsia, eclampsia	17 month