Uterine Atony With HemorrhageNCT03930407
Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture
An observational study of Uterine Atony With Hemorrhage and Ovarian Dysfunction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
From patient charts we will review patients who had undergone cesarean section within the last 6 months and identify those who received a The Hayman uterine compression suture for uterine atony. We will also select patients who delivered a baby without recieving a Hayman suture to create a control group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Uterine Atony With Hemorrhage, Ovarian Dysfunction
- What is being tested?
- The Hayman uterine compression suture.
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 15 Jun 2019
- 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 40 years
- Women only
- Adult
Study population: Patients who had undergone uterine artery ligation during cesarean section. Control group is age-matched postpartum patients.
Who may be able to join
- age 18- 40 years
- no systemic or endocrine diseases
- patients who had uterine artery ligation due to atony
- healthy postpartum patients as controls
Who cannot join
- patients with Polyctsitic over syndrome
- Pregnancy with IVF or oocyte donation
- Obese patients
- patients with previous/present endometriosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
Istanbul, Please Enter the State Or Province, 34005
Aysu Akca, 2124041500, aysuakca4@gmail.com
About this study
Official title: Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture for Uterine Atony During Cesarean Section
From patient charts we will review patients who had undergone cesarean section within the last 6 months and identify those who received a The Hayman uterine compression suture for uterine atony. We will also select patients who delivered a baby without recieving a Hayman suture to create a control group. Patietns will be grouped as Hayman Group if they recevied a Hayman suture during C/S and control group if thay had not recevied a Hayman suture. We will then check patient charts for post-cesarean outpatient clinic visit and select those who received ovarian reserve evaluation via hormones and antral follicle count during the visits. Finally, we are planning to investigate any correlation between Hayman suture and ovarian dysfunction.
Read the detailed description
Hayman suture is a common technique for uterine compression to stop bleeding due to uterine atony. Hayman described placement of two to four vertical compression sutures from the anterior to posterior uterine wall without hysterectomy. It is usually employed to overcome uterine atoy dıring cesarean section. However, since the technique is relatively new, data on its safety and efficacy arelimited to a few case reports. several complications including cavity obliteration, blood entrapment and infections have been described. However, data regarding the ovarioan function is lacking.
- Conditions
- Uterine Atony With Hemorrhage, Ovarian Dysfunction
- Being tested
- The Hayman uterine compression suture.
- Keywords
- Cesarean section, Uterine atony, Hayman uterine compression suture, Follicle-stimulating hormone, Luteinizing hormone, Antral follicle count
- Medical subject headings
- Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Hayman uterine compression suture.Procedure or surgery
Hayman suture is a common technique for uterine compression to stop bleeding due to uterine atony. Hayman described placement of two to four vertical compression sutures from the anterior to posterior uterine wall without hysterectomy. It is usually employed to overcome uterine atony during cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Hayman group | Who had undergone cesarean section within the last 6 months and received a The Hayman uterine compression suture for uterine atony. Receives: Procedure: The Hayman uterine compression suture. | |
| Control | Who had undergone cesarean section within the last 6 months and did not experience neither any complication nor any additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean
ng/dl
Measured: Before cesarean section and at any follow-up visit within 6 months of cesarean section
Change in follicle stimulating hormone level from baseline (precesarean) to post-cesarean
IU/L
Measured: Before cesarean section and at any follow-up visit within 6 months of cesarean section
Change in luteinizing hormone level from baseline (precesarean) to post-cesarean
mU/mL
Measured: Before cesarean section and at any follow-up visit within 6 months of cesarean section
Secondary outcomes (1)
Antral follicle count in the two study groups
number
Measured: At any follow-up visit within 6 months of cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start15 Apr 2019
- Primary completion10 Jun 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Atony With HemorrhageStudies 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Asyu Akca, Principal investigator, Kanuni Sultan Suleyman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930407
- Sponsor's protocol ID
- AYSUAKCA1
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 29 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture for Uterine Atony During Cesarean Section
- ClinicalTrials.gov ID
- NCT03930407
- Acronym / sponsor ID
- AYSUAKCA1
- Conditions
- Uterine Atony With Hemorrhage, Ovarian Dysfunction
- Keywords
- Cesarean section, Uterine atony, Hayman uterine compression suture, Follicle-stimulating hormone, Luteinizing hormone, Antral follicle count
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 10 Jun 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 29 Apr 2019 (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.
From patient charts we will review patients who had undergone cesarean section within the last 6 months and identify those who received a The Hayman uterine compression suture for uterine atony. We will also select patients who delivered a baby without recieving a Hayman suture to create a control group. Patietns will be grouped as Hayman Group if they recevied a Hayman suture during C/S and control group if thay had not recevied a Hayman suture. We will then check patient charts for post-cesarean outpatient clinic visit and select those who received ovarian reserve evaluation via hormones and antral follicle count during the visits. Finally, we are planning to investigate any correlation between Hayman suture and ovarian dysfunction.
Detailed description
Hayman suture is a common technique for uterine compression to stop bleeding due to uterine atony. Hayman described placement of two to four vertical compression sutures from the anterior to posterior uterine wall without hysterectomy. It is usually employed to overcome uterine atoy dıring cesarean section. However, since the technique is relatively new, data on its safety and efficacy arelimited to a few case reports. several complications including cavity obliteration, blood entrapment and infections have been described. However, data regarding the ovarioan function is lacking.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hayman group | – | Procedure: The Hayman uterine compression suture.Who had undergone cesarean section within the last 6 months and received a The Hayman uterine compression suture for uterine atony. |
| Control | – | –Who had undergone cesarean section within the last 6 months and did not experience neither any complication nor any additional intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients who had undergone uterine artery ligation during cesarean section. Control group is age-matched postpartum patients.
Key inclusion criteria (4 listed)
- age 18- 40 years
- no systemic or endocrine diseases
- patients who had uterine artery ligation due to atony
- healthy postpartum patients as controls
Key exclusion criteria (4 listed)
- patients with Polyctsitic over syndrome
- Pregnancy with IVF or oocyte donation
- Obese patients
- patients with previous/present endometriosis
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 |
|---|---|---|
| The Hayman uterine compression suture.Hayman suture is a common technique for uterine compression to stop bleeding due to uterine atony. Hayman described placement of two to four vertical compression sutures from the anterior to posterior uterine wall without hysterectomy. It is usually employed to overcome uterine atony during cesarean section. | Procedure or surgery | Hayman group |
Primary outcome
Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean
Time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section
ng/dl
Change in follicle stimulating hormone level from baseline (precesarean) to post-cesarean
Time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section
IU/L
Change in luteinizing hormone level from baseline (precesarean) to post-cesarean
Time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section
mU/mL
1 secondary outcome
Antral follicle count in the two study groups
Time frame: At any follow-up visit within 6 months of cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Asyu Akca principal investigator
Kanuni Sultan Suleyman 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 Uterine Atony With Hemorrhage and Ovarian Dysfunction, run by Kanuni Sultan Suleyman 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 4 inclusion and 4 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 29 Apr 2019. 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 Aysu Akca, MD (+905053868637, aysuakca4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean (time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2019.