Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

• Conditions: Uterine Atony With Hemorrhage; Ovarian Dysfunction
• Interventions: Procedure: The Hayman uterine compression suture.

• Registration Number: NCT03930407
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-15
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-25
• Last Update Submitted: 2019-04-25
• Study First Posted: 2019-04-29
• Last Update Posted: 2019-04-29
• Primary Completion: 2019-06-10
• Study Completion: 2019-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

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Exclusion Criteria

• patients with Polyctsitic over syndrome
• Pregnancy with IVF or oocyte donation
• Obese patients
• patients with previous/present endometriosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hayman group	The Hayman uterine compression suture.	Who had undergone cesarean section within the last 6 months and received a The Hayman uterine compression suture for uterine atony.

Primary Outcome Measures

Name	Time	Method
Change in follicle stimulating hormone level from baseline (precesarean) to post-cesarean	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	Before cesarean section and at any follow-up visit within 6 months of cesarean section	mU/mL
Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean	Before cesarean section and at any follow-up visit within 6 months of cesarean section	ng/dl

Secondary Outcome Measures

Name	Time	Method
Antral follicle count in the two study groups	At any follow-up visit within 6 months of cesarean section	number

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,; 🇹🇷 Istanbul, Please Enter The State Or Province, Turkey