NCT03930407

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 23, 2019

Last Update Submit

April 25, 2019

Conditions

Uterine Atony With HemorrhageOvarian Dysfunction

Keywords

Cesarean sectionUterine atonyHayman uterine compression sutureFollicle-stimulating hormoneLuteinizing hormoneAntral follicle count

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Antral follicle count in the two study groups

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

Study Arms (2)

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

The Hayman uterine compression suture.PROCEDURE

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.

Hayman group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • age 18- 40 years
  • no systemic or endocrine diseases
  • patients who had uterine artery ligation due to atony
  • healthy postpartum patients as controls

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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 (Türkiye)

RECRUITING

MeSH Terms

Conditions

Uterine Inertia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Asyu Akca

    Kanuni Sultan Suleyman Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysu Akca, MD

CONTACT

+905053868637aysuakca4@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 29, 2019

Study Start

April 15, 2019

Primary Completion

June 10, 2019

Study Completion

June 15, 2019

Last Updated

April 29, 2019

Record last verified: 2019-04

Locations

TU(1)