Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

Uterine Atony With Hemorrhage Clinical Trial

Official title:

Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture for Uterine Atony During Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03930407
• Other study ID #: AYSUAKCA1
• Status: Recruiting
• Start date: April 15, 2019
• Est. completion date: June 15, 2019

Study information

• Verified date: April 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Aysu Akca, MD
• Phone: +905053868637
• Email: aysuakca4[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 15, 2019
• Est. primary completion date: June 10, 2019
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Ovarian Dysfunction
• Uterine Atony With Hemorrhage
• Uterine Inertia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,	Istanbul	Please Enter The State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Antral follicle count in the two study groups	number	At any follow-up visit within 6 months of cesarean section