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Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

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ClinicalTrials.gov Identifier: NCT03930407
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital

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.

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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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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 :
  1. Antral follicle count in the two study groups [ Time Frame: At any follow-up visit within 6 months of cesarean section ]
    number



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930407


Contacts
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Contact: Aysu Akca, MD +905053868637 aysuakca4@gmail.com

Locations
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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
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Principal Investigator: Asyu Akca Kanuni Sultan Suleyman Hospital
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Responsible Party: Aysu Akca, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03930407    
Other Study ID Numbers: AYSUAKCA1
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital:
Cesarean section
Uterine atony
Hayman uterine compression suture
Follicle-stimulating hormone
Luteinizing hormone
Antral follicle count
Additional relevant MeSH terms:
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Uterine Inertia
Hemorrhage
Pathologic Processes
Dystocia
Obstetric Labor Complications
Pregnancy Complications