Clinical trial NCT03930407: Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture
Official title: Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture for Uterine Atony During Cesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uterine Atony With Hemorrhage
Ovarian Dysfunction
Keywords: Cesarean section
Uterine atony
Hayman uterine compression suture
Follicle-stimulating hormone
Luteinizing hormone
Antral follicle count
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had undergone uterine artery ligation during cesarean section. Control group is age-matched postpartum patients.

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.

Eligibility 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

Primary outcomes:
measure: Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean
timeFrame: Before cesarean section and at any follow-up visit within 6 months of cesarean section
measure: Change in follicle stimulating hormone level from baseline (precesarean) to post-cesarean
timeFrame: Before cesarean section and at any follow-up visit within 6 months of cesarean section
measure: Change in luteinizing hormone level from baseline (precesarean) to post-cesarean
timeFrame: Before cesarean section and at any follow-up visit within 6 months of cesarean section
Secondary outcomes:
measure: Antral follicle count in the two study groups
timeFrame: At any follow-up visit within 6 months of cesarean section
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Asyu Akca
role: PRINCIPAL_INVESTIGATOR
References: