NCT04690153

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

5.3 years

First QC Date

December 19, 2020

Last Update Submit

December 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    5 years

Interventions

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Inertia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

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

Study Record Dates

First Submitted

December 19, 2020

First Posted

December 30, 2020

Study Start

August 15, 2015

Primary Completion

December 10, 2020

Study Completion

December 15, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations