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Completed

NCT Number: NCT04690153

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.

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Key information

Conditions

Uterine Atony Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases Uterine Inertia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Patients with three vertical Hayman Sutures

Other

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.

Primary outcomes

  1. Reduce maternal deaths due to bleeding

    Time frame: 5 years

    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.

Secondary outcomes

  1. to prevent and reduce complications seen in mothers in the post-operative period due to bleeding,

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

Pınar Yalcin bahat

Other

Collaborators

  • Ismail Ozdemir

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2020
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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