Novel Approach of Hayman Uterine Compression Sutures for Management of Severe Atonic Postpartum Hemorrhage: Three Vertical Sutures

Maternal deaths due to uterine atony bleeding are the leading causes of maternal death in our country and all over the world. In this respect, our clinic is among the clinics with the highest number of experience in our country and aims to reduce maternal deaths and mothers who will need intensive care due to bleeding with a hemorrhage stopping technique that will have a serious contribution to both our country and the world literature.

Our primary goal, thanks to the bleeding-stopping technique, to reduce their deaths. Our secondary aim is, thanks to the bleeding-stopping technique we offer, To prevent and reduce the complications seen in mothers during the operative period.

Study Overview

• Status: Completed
• Conditions: Uterine Atony
• Intervention / Treatment: Other: Patients with three vertical Hayman Sutures

Detailed Description

Our research was carried out to our obstetrics clinic between 01 Agustus 2015 - 01 December 2020.

Patients transplanted due to postpartum bleeding and patients requiring surgery due to abnormal postpartum bleeding in our clinic will be included. Patients with a previously known bleeding disorder will not be included in the study. In our study, the parameters of the patients who had bleeding due to postpartum uterine atony and who needed uterine surgery previously underwent triple Hayman compression suture to stop bleeding will be included in the study. Patients with a triple Hayman suture covering the upper 2/3 of the uterus to stop uterine bleeding will be evaluated in the study.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34000
      • Pinar Yalcin Bahat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients with abnormal uterine bleeding other than birth Patients with known metabolic diseases Patients with known bleeding and coagulation disorders

Description

Inclusion Criteria:

• Postpartum bleeding after birth
• Patients referred to our clinic from an external center due to postpartum bleeding
• Patients who have given birth due to pregnancy older than 24 weeks and have atony bleeding

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce maternal deaths due to bleeding	Maternal death due to uterine atony is common all over the world, especially in developing countries. Thanks to the technique we apply, it is aimed to reduce bleeding and decrease maternal deaths.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to prevent and reduce complications seen in mothers in the post-operative period due to bleeding,	Some complications may occur due to excessive bleeding after uterine atony. These complications can be permanent or fatal. (for example, acute renal failure, disseminated intravascular coagulation disorder, etc., it is aimed to reduce these with the applied technique.	5 years

Collaborators and Investigators

• Sponsor: Pınar Yalcin bahat
• Collaborators: Ismail Ozdemir

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2015
• Primary Completion (ACTUAL): December 10, 2020
• Study Completion (ACTUAL): December 15, 2020

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (ACTUAL): December 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Dystocia; Hemorrhage; Postpartum Hemorrhage; Uterine Inertia
• Other Study ID Numbers: hayman

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No