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临床试验/NCT05135026
NCT05135026Unknown不适用

Ultrasonography and Health Education During the Antenatal Visits Among the Pregnant Women to Reduce the Unnecessary Caesarean Section in a Resource Poor Setting (Bangladesh): a Cluster Randomized Control Trial

Hiroshima University1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2021年11月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
288
试验地点
1
主要终点
Unnecessary C/S

研究概览

简要总结

A caesarean section (C/S) is a surgical procedure performed to prevent difficulties during childbirth. World Health Organization considered the standard rate for the C/S would be between 10% and 15%. However, since 2000 the rate of C/S was increasing globally, and it became about twofold from 12.1% to 21.1% in 2015.

In Bangladesh, C/S continued to increase from 8% (2007) to 33% (2017). Medically unnecessary C/S was estimated about 77% of all C/S in 2018, and it was increased from 66% since 2016. In Bangladesh, unnecessary C/S observed 9.0% and 3.2% C/S done due to avoid labour pain and 5.8% for the convenience of the mother. The economic burden of each C/S is average USD 612 and unfortunately, each patient spends this amount of money from out of pocket. Aim of this study is to do ultrasonography and health education can reduce unnecessary caesarean section among pregnant women compared to control group in a resource poor setting.

Investigators will conduct this randomized controlled trial (RCT) at Dhaka and Sir Salimullah Medical College & Hospital, and two rural Upazila Health Complexes (Savar Upazila Health Complex and Munshigonj General Hospital). Investigators will randomly select one urban hospital from two urban hospitals and one rural hospital from two rural hospitals for the intervention. The other one urban and one rural hospital will be assigned as control hospitals. One research staff, who will not involve any of the research activity of this trial, will do this randomization. Pregnant mothers will be identified and recruited during their routine antenatal visits. Pregnant mothers receive 2 USG during their routine ANC visits at 1st visit of 8-12 weeks and 4th visit of 36-38 weeks. In the intervention centres, Investigators will perform additional 4 ANC visits at 20, 30, 36 and 40 weeks (total 8 visits) and USG additional 2 times during the 2nd visit of 24-26 weeks and 5th visit of 34 weeks (2 routine USG + 2 USG in 3rd and 5th ANC visits and even more USG if needed + Health education; pictorial flip chart showing danger sign during pregnancy and potential risks for unnecessary caesarean delivery to increase awareness for safe delivery) for all the enrolled pregnant mothers. In the control centres, Investigators will collect information from the pregnant mothers.

Investigators are expecting the pregnant women who will receive antenatal care with ultrasonography and health education will have reduced number of unnecessary C/S compared to control group who will not receive those.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

One research staff, who will not be involved any of the research activity of this trial, will do this randomization.

入排标准

性别
Female
接受健康志愿者

入选标准

  • All the pregnant mothers irrespective of age who will be attending the designated hospitals/health complex.
  • We will include all pregnant mothers who will have/have not complication to see the delivery outcome with indication of normal delivery and CS.
  • Willing to participate in the study.

排除标准

  • Not willing to participate.
  • Early Pregnancy with indication for C/S (co-morbidities, H/O previous C/S etc.)

结局指标

主要结局

Unnecessary C/S

时间窗: 36 weeks

Compare the reduction of the percentage of unnecessary C/S among the intervention compare to control pregnant women

次要结局

  • ANC(36 weeks)
  • USG(36 weeks)
  • Institutional (hospital and clinics) delivery compare to the home delivery(36 weeks)
  • Rate of still birth(36 weeks)
  • Delivery related complications(36 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Habiba Shirin

Principal Investigator

Hiroshima University

研究点 (1)

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