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Status unknownNCT03930407Updated Apr 29, 2019

Serum Antimullerian Hormone Levels in Patients Who Underwent Hayman Suture

An observational study in Uterine Atony With Hemorrhage and Ovarian Dysfunction, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
120
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Uterine Atony With Hemorrhage
  • Ovarian Dysfunction

Keywords

  • Cesarean section
  • Uterine atony
  • Hayman uterine compression suture
  • Follicle-stimulating hormone
  • Luteinizing hormone
  • Antral follicle count
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In context

Uterine Inertia

34 studies on the registry are indexed under Uterine Inertia; 6 are open to participants now.

Browse Uterine Inertia studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Patients who had undergone uterine artery ligation during cesarean section. Control group is age-matched postpartum patients.

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

Exclusion Criteria:

  • patients with Polyctsitic over syndrome
  • Pregnancy with IVF or oocyte donation
  • Obese patients
  • patients with previous/present endometriosis
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

  • Control

    Who had undergone cesarean section within the last 6 months and did not experience neither any complication nor any additional intervention

Interventions

  • ProcedureThe 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.

06

What researchers measure

Primary outcomes

  1. Change in anti-mullerian hormone level from baseline (precesarean) to post-cesarean

    ng/dl

    Time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section

  2. Change in follicle stimulating hormone level from baseline (precesarean) to post-cesarean

    IU/L

    Time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section

  3. Change in luteinizing hormone level from baseline (precesarean) to post-cesarean

    mU/mL

    Time frame: Before cesarean section and at any follow-up visit within 6 months of cesarean section

Secondary outcomes

  1. Antral follicle count in the two study groups

    number

    Time frame: At any follow-up visit within 6 months of cesarean section

07

Study locations

1 of 1 sites recruiting
  • Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
    Istanbul, Please Enter The State Or Province 34005, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03930407
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Aysu Akca (Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Apr 29, 2019
Start date
Apr 15, 2019
Primary completion
Jun 10, 2019 (estimated)
Completion
Jun 15, 2019 (estimated)
Last update
Apr 29, 2019

Study contacts

Aysu Akca, MD
Contact
aysuakca4@gmail.com
+905053868637
Asyu Akca
principal investigator · Kanuni Sultan Suleyman Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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