Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Atony With Hemorrhage; Ovarian Dysfunction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Aysu Akca, MD; Phone Number: +905053868637; Email: aysuakca4@gmail.com

Study Locations

• Turkey
  • Please Enter The State Or Province
    • Istanbul, Please Enter The State Or Province, Turkey, 34005
      • Recruiting
      • Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
      • Contact: Aysu Akca; Phone Number: 2124041500; Email: aysuakca4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean	ng/dl	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	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	Before cesarean section and at any follow-up visit within 6 months of cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antral follicle count in the two study groups	number	At any follow-up visit within 6 months of cesarean section

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Asyu Akca, Kanuni Sultan Suleyman Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Anticipated): June 10, 2019
• Study Completion (Anticipated): June 15, 2019

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cesarean section; Antral follicle count; Uterine atony; Hayman uterine compression suture; Follicle-stimulating hormone; Luteinizing hormone
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Dystocia; Hemorrhage; Uterine Inertia
• Other Study ID Numbers: AYSUAKCA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No