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临床试验/CTRI/2025/08/093673
CTRI/2025/08/093673尚未招募不适用

The study of risk factors associated with PostPartum Hemorrhage : A Cross Sectional study in a teritiary care centre

Mallavolu Venkata Sai Naga Akhila1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To indentify the risk factors associated with postpartum hemorrhage in a tertiary care centre

研究概览

简要总结

Introduction and Need for the study:

Postpartum hemorrhage continues to be one of the leading causes of maternal mortality and morbidity, accounting for about 19.7% all pregnancy related deaths worldwide . Primary PPH is typically defined as bleeding from Genital tract of 500 ml or more in first 24 hours of delivery of baby  blood loss of greater than 1000ml following Cesarean delivery of baby.

The main causes or etiologies of post partum hemorrhage have traditionally been described as fourfold , giving the mnemonic 4 T’s ; Uterine atony( Tone), genital tract or surgical trauma (Trauma), retained placenta or parts of placental tissue(Tissue) and coagulopathies ( Thrombin). Most studies report Uterine atony or failure of the uterus to contract after delivery to be main cause of PPH.

Late postpartum hemorrhage  is bleeding after 24 hours of delivery of baby. Severe morbidities associated with PPH include anemia, disseminated intravascular coagulation, blood transfusion, hysterectomy and renal or liver failure. Identifiable risk factors are believed to include: a history of prior PPH, nulliparity, overdistended uterus, placental abnormalities such as placenta previa or placenta accrete, coagulation abnormalities , anemia, induction of labor , augmentation of labor and prolonged labor.

Given increasing cesarean section rates and different risk factors reportedly associated with vaginal and cesarean births, it is worthwhile considering the outcomes following postpartum hemorrhage separately for these birth modes

Despite advances in obstetric care, the condition remains unpredictable and often rapidly progressive. Tertiary care centres manage a high proportion of high risk pregnancies such as post partum hemorrhage making it essential to generate specific data. The rising incidence of Postpartum hemorrhage and very less Indian articles about the condition makes it essential to study.

The main aim of my study is to identify the risk factors associated with PPH, maternal outcomes. Additionally we sought to describe the use of blood transfusions, medical and invasive management techniques commonly used to manage

Data collection procedure :

Over a period of 12 months ,all the pregnant women with  greater than 28 weeks period of gestation whose pregnancies are complicated by postpartum hemorrhage admitted in labor room/ obstetric ward, Intensive care units, Emergency department of  KLE’s Dr. Prabhakar Kore Hospital, Belagavi  will be screened and included in the study after obtaining informed consent

Measure the estimated blood loss or quantify it via validated method

Document vital signs such as blood pressure , pulse rate , respiratory rate and to note any ongoing signs of hemorrhage  Maternal characteristics include age, gravid, parity, gestational age at delivery , prior history of PPH, mode of delivery( vaginal or cesarean), any complications in previous delivery

Detailed antenatal history and presenting complaints will be noted

The general examination and detailed obstetrics examination ( uterine tone, presence of retained placental fragments or clots, presence of genital trauma etc

Maternal outcomes to Postpartum hemorrhage such as need for blood transfusion,  uterotonics,  uterine massage , surgical intervention) will be taken into accoun

Baseline and post hemorrhage hemoglobin values to be compared

Other routine investigations like Complete blood count, Urine routine and examination, serum thyroid stimulating hormone, DIPSI, HIV Status, HBsAg status, VDRL Status will be noted.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Age greater than or equal to 18 years of age.
  • 2.All the pregnant women with greater than 28 weeks Period of gestation with delivery complicated by postpartum haemorrhage.
  • 3.Women who provide written informed consent to participate in the study.

排除标准

  • 1.Women with incomplete medical records or without reliable blood loss measurement data 2.Women who refuse or withdraw consent.

结局指标

主要结局

To indentify the risk factors associated with postpartum hemorrhage in a tertiary care centre

时间窗: greater than 28 weeks

次要结局

  • Maternal outcomes in deliveries complicated by postpartum hemorrhage(greater than 28 weeks)

研究者

发起方
Mallavolu Venkata Sai Naga Akhila
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mallavolu Venkata Sai Naga Akhila

Jawaharlal Nehru Medical College , Belagavi

研究点 (1)

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