The Effect of Adenomoyosis on Pregnancy Outcomes

Adverse Obstetrical Outcomes for Women With Adenomyosis

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Adenomyosis
• Intervention / Treatment: Other: Non intervention

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Abdurrahman Hamdi İnan, Assoc. Prof.; Phone Number: (0232) 373 89 21; Email: ahamdiinan@gmail.com

Study Locations

• Turkey
  • İzmir, Turkey
    • Recruiting
    • Tepecik Education and Research Hospital
    • Contact: Göksel Kanmaz, Assoc. Prof.; Phone Number: +905308205483; Email: drgokselkanmaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adenomyosis Group	Other: Non intervention; During the study there is no extra intervention planned for the participants.
Non-adenomyosis Group	Other: Non intervention; During the study there is no extra intervention planned for the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy complication	Preterm labour	15 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy complication	placental anomalies	16 month
Pregnancy complication	preeclampsia, eclampsia	17 month

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital
• Investigators: Study Director: Ahkam Göksel Kanmaz, Assoc. Prof., Tepecik Education and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: May 16, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 23, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; adenomyosis; pregnancy complications; MUSA classification
• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis; Pregnancy Complications
• Other Study ID Numbers: TepecikTRH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No