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出境医 / 临床实验 / Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture
Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Uterine Atony With Hemorrhage Ovarian Dysfunction | Procedure: The Hayman uterine compression suture. |
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
| Study Type : | Observational |
| Estimated Enrollment : | 120 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture for Uterine Atony During Cesarean Section |
| Actual Study Start Date : | April 15, 2019 |
| Estimated Primary Completion Date : | June 10, 2019 |
| Estimated Study Completion Date : | June 15, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Hayman group
Who had undergone cesarean section within the last 6 months and received a The Hayman uterine compression suture for uterine atony.
|
Procedure: 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.
|
|
Control
Who had undergone cesarean section within the last 6 months and did not experience neither any complication nor any additional intervention
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Antral follicle count in the two study groups [ Time Frame: At any follow-up visit within 6 months of cesarean section ]number
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Sampling Method: | Probability Sample |
Study Population
Patients who had undergone uterine artery ligation during cesarean section. Control group is age-matched postpartum patients.
Criteria
Inclusion Criteria:
- age 18- 40 years
- no systemic or endocrine diseases
- patients who had uterine artery ligation due to atony
- healthy postpartum patients as controls
Exclusion Criteria:
- patients with Polyctsitic over syndrome
- Pregnancy with IVF or oocyte donation
- Obese patients
- patients with previous/present endometriosis
Contacts and Locations
Contacts
| Contact: Aysu Akca, MD | +905053868637 | aysuakca4@gmail.com |
Locations
| Turkey | |
| Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, | Recruiting |
| Istanbul, Please Enter The State Or Province, Turkey, 34005 | |
| Contact: Aysu Akca 2124041500 aysuakca4@gmail.com | |
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
| Principal Investigator: | Asyu Akca | Kanuni Sultan Suleyman Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 23, 2019 | ||||
| First Posted Date | April 29, 2019 | ||||
| Last Update Posted Date | April 29, 2019 | ||||
| Actual Study Start Date | April 15, 2019 | ||||
| Estimated Primary Completion Date | June 10, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Antral follicle count in the two study groups [ Time Frame: At any follow-up visit within 6 months of cesarean section ] number
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture | ||||
| Official Title | Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture for Uterine Atony During Cesarean Section | ||||
| Brief 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. 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 Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients who had undergone uterine artery ligation during cesarean section. Control group is age-matched postpartum patients. | ||||
| Condition |
|
||||
| Intervention | Procedure: 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.
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
120 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 15, 2019 | ||||
| Estimated Primary Completion Date | June 10, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 40 Years (Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03930407 | ||||
| Other Study ID Numbers | AYSUAKCA1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital | ||||
| Study Sponsor | Kanuni Sultan Suleyman Training and Research Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Kanuni Sultan Suleyman Training and Research Hospital | ||||
| Verification Date | April 2019 | ||||
