Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

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

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

Groups and Cohorts

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 :

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 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

More Information

• 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
• 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 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:

Uterine Inertia; Hemorrhage; Pathologic Processes; Dystocia; Obstetric Labor Complications; Pregnancy Complications