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Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

  • Clinicaltrials.gov identifier

    NCT03930407

  • Recruitment Status

    Recruiting

  • First Posted

    April 29, 2019

  • Last update posted

    April 29, 2019

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:Ovarian Dysfunction
    Uterine Atony With Hemorrhage
  • Intervention/Treatment: Procedure: The Hayman uterine compression suture.
  • Phase: N/A

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 2019
  • Estimated Primary Completion Date: June 2019
  • Estimated Study Completion Date: June 2019

Groups and Cohorts

Groups/Cohorts 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.

Outcome Measures

  • 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

Eligibility Criteria

  • Ages Eligible for Study: 18 to 40 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers:
  • 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, Please Enter The State Or Province
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
Istanbul

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Principal Investigator: Asyu Akca Kanuni Sultan Suleyman Hospital

More Information

  • Responsible Party: Kanuni Sultan Suleyman Training and Research Hospital
  • ClinicalTrials.gov Identifier: NCT03930407 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Kanuni Sultan Suleyman Training and Research Hospital: Luteinizing hormone
    Hayman uterine compression suture
    Cesarean section
    Uterine atony
    Follicle-stimulating hormone
    Antral follicle count
  • Additional relevant MeSH terms: Uterine Inertia Hemorrhage