The Effect of Adenomoyosis on Pregnancy Outcomes

• Conditions: Pregnancy Complications; Adenomyosis
• Interventions: Other: Non intervention

• Registration Number: NCT04894292
• Lead Sponsor: Tepecik Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-05-16
• Study Start: 2021-05-20
• Study First Posted: 2021-05-20
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25
• Primary Completion: 2022-08
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adenomyosis Group	Non intervention	-
Non-adenomyosis Group	Non intervention	-

Primary Outcome Measures

Name	Time	Method
Pregnancy complication	15 month	Preterm labour

Secondary Outcome Measures

Name	Time	Method
Pregnancy complication	17 month	preeclampsia, eclampsia

Trial Locations

Locations (1)

Tepecik Education and Research Hospital; 🇹🇷 İzmir, Turkey