The Effect of Adenomoyosis on Pregnancy Outcomes

Sponsor
Tepecik Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04894292
Collaborator
(none)
150
1
18.4
8.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Adverse Obstetrical Outcomes for Women With Adenomyosis
Actual Study Start Date :
May 20, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Pregnancy complication [15 month]

    Preterm labour

Secondary Outcome Measures

  1. Pregnancy complication [16 month]

    placental anomalies

  2. Pregnancy complication [17 month]

    preeclampsia, eclampsia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tepecik Education and Research Hospital İzmir Turkey

Sponsors and Collaborators

  • Tepecik Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahkam Göksel Kanmaz, Assoc. Prof, Tepecik Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04894292
Other Study ID Numbers:
  • TepecikTRH-001
First Posted:
May 20, 2021
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahkam Göksel Kanmaz, Assoc. Prof, Tepecik Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2021