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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03930407
Other study ID # AYSUAKCA1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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