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

Uterine Atony Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690153
• Other study ID #: hayman
• Status: Completed
• Start date: August 15, 2015
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 15, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Uterine Atony
• Uterine Inertia

Intervention

Other:
• Patients with three vertical Hayman Sutures
Patients who are referred to our clinic due to postpartum hemorrhage between the ages of 18-45 and who need to undergo a surgical procedure (not responding to medical treatment) due to abnormal uterine bleeding in our clinic will be included. Patients with a previously known diagnosis of bleeding and coagulation disorders will not be included in the study. Considering that we are one of the primary referral centers in Istanbul in terms of deliveries and post-partum bleeding in our hospital, it is aimed to terminate the study with approximately 50 participants.

Locations

Country	Name	City	State
Turkey	Pinar Yalcin Bahat	Istanbul	I?stanbul

Sponsors (2)

Lead Sponsor	Collaborator
Pinar Yalcin bahat	Ismail Ozdemir

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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