AdenomyosisNCT04894292
The Effect of Adenomoyosis on Pregnancy Outcomes
An observational study of Adenomyosis and Pregnancy Complications, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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%. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis, Pregnancy Complications
- What is being tested?
- Non intervention
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2021to Dec 2022
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Age between 18-35 years
- Being diagnosed before the 6th gestational week
- Having all pregnancy follow-ups and deliveries in our hospital
Who cannot join
- Previous uterine surgery
- Multiple pregnancies
- Pregnant women with uterine malformations
- Pregnant women with fetal anomalies
- Those who got pregnant using assisted reproductive technique
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tepecik Education and Research Hospital
Izmir
Göksel Kanmaz, Assoc. Prof., +905308205483, drgokselkanmaz@gmail.com
About this study
Official title: 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.
- Conditions
- Adenomyosis, Pregnancy Complications
- Being tested
- Non intervention
- Keywords
- adenomyosis, pregnancy complications, MUSA classification, ultrasound
- Medical subject headings
- Adenomyosis, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
During the study there is no extra intervention planned for the participants.
| Study group | Role | What they receive |
|---|---|---|
| Adenomyosis Group | Not described Receives: Other: Non intervention | |
| Non-adenomyosis Group | Not described Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy complication
Preterm labour
Measured: 15 month
Secondary outcomes (2)
Pregnancy complication
placental anomalies
Measured: 16 month
Pregnancy complication
preeclampsia, eclampsia
Measured: 17 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start20 May 2021
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahkam Göksel Kanmaz, Tepecik Training and Research Hospital
- Investigators
- Ahkam Göksel Kanmaz, Assoc. Prof., Study director, Tepecik Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894292
- Sponsor's protocol ID
- TepecikTRH-001
- Status last verified
- May 2021
- First submitted
- 16 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31374085Horton 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.
PubMed 31318420
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Obstetrical Outcomes for Women With Adenomyosis
- ClinicalTrials.gov ID
- NCT04894292
- Acronym / sponsor ID
- TepecikTRH-001
- Conditions
- Adenomyosis, Pregnancy Complications
- Keywords
- adenomyosis, pregnancy complications, MUSA classification, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenomyosis Group | – | Other: Non intervention |
| Non-adenomyosis Group | – | Other: Non intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Age between 18-35 years
- Being diagnosed before the 6th gestational week
- Having all pregnancy follow-ups and deliveries in our hospital
Key exclusion criteria (5 listed)
- Previous uterine surgery
- Multiple pregnancies
- Pregnant women with uterine malformations
- Pregnant women with fetal anomalies
- Those who got pregnant using assisted reproductive technique
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionDuring the study there is no extra intervention planned for the participants. | Other | Adenomyosis Group, Non-adenomyosis Group |
Primary outcome
Pregnancy complication
Time frame: 15 month
Preterm labour
2 secondary outcomes
Pregnancy complication
Time frame: 16 month
Pregnancy complication
Time frame: 17 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Background: PubMed 31374085Harada 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.
- Background: PubMed 31318420Horton 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.
- Individual participant dataSharing planned: Undecided
Related trials for Adenomyosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahkam Göksel Kanmaz, Assoc. Prof. study director
Tepecik Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Pregnancy Complications, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdurrahman Hamdi İnan, Assoc. Prof. ((0232) 373 89 21, ahamdiinan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy complication (time frame: 15 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.