跳至主要内容
临床试验/CTRI/2025/09/095475
CTRI/2025/09/095475招募中不适用

Impact of Bereavement care on Maternal satisfaction in cases of stillbirth.

Dr Sarita Beri1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Process measure:

研究概览

简要总结

RESEARCH QUESTION: Will improving the practice of bereavement care increase maternal satisfaction after stillbirth in a tertiary care hospital?

 Primary Objective

1. To assess the maternal satisfaction with the bereavement care provided at LHMC.

 Secondary Objective

**1.**To assess the improvement in the practice of bereavement care at LHMC.

**2.**To determine the cause of stillbirth according to International classification of diseases -10 Perinatal Mortality (ICD-10 PM) classification.

 MATERIAL AND METHODS

 Inclusion Criteria

All women delivering a stillborn baby.

 Operational Definition

For inter country comparisons, World health organization (WHO) defines Stillbirth as the birth of a baby with no signs of life at birth at or after 28 weeks of gestation, or with a birth weight of 1000gms or more when the gestational age is not known.1

 METHODOLOGY: All subjects fulfilling inclusion criteria will be recruited from the department of obstetrics and gynaecology of Lady Hardinge Medical College and Smt. Sucheta Kriplani Hospital from the time of admission to labour room till 24 hours after delivery. Informed consent will be taken from all mothers participating in the study.

 Planning the intervention:

1.      Making a healthcare team consisting of staff nurses and doctors posted in the labour room.

2.      Assessing the team’s awareness about bereavement care using a pre-structured questionnaire for the healthcare team (appendix I).

3.      Training of healthcare staff on the first 3 days of the month in the following manner:

Conducting role play sessions to sensitise them about breaking bad news empathetically, responding to emotional distress and handling emotionally charged situations well.

Making videos of mothers lived experiences and sharing it with our team to highlight the need of bereavement care. Confidentiality of patients will be ensured.

This will be followed with an interactive discussion regarding respectful maternity care, psychological support, & lactation suppression.

 Implementation of change:

**1.**In the event of stillbirth, the health team will provide standard bereavement care.

**2.**A checklist of the essential components of care (bereavement care guide, appendix III) will be ticked according to the care provided and each component will get one point.

**3.**Total score will be given for each bereavement counselling session, and two weekly assessments of scores will be done.

**4.**Fish bone analysis of the possible barriers in implementation will be done.

**5.**PDSA cycles will be carried out.

**6.**Change in mean utilization score from beginning to the end of the month will be the process measure.

 Assessment of outcome:

**1.**After 24 hours of stillbirth, “Maternity bereavement experience measure (MBEM)” questionnaire will be filled by the mothers experiencing stillbirth

**2.**The change in mean satisfaction score from beginning to the end of the study will be the outcome measure.

 “STANDARD BEREAVEMENT CARE” BUNDLE7:

Bereavement care will be given in a bereavement room, identified within the labour room complex.

1. Communication: Healthcare team will be encouraged to follow the SPIKES protocol while breaking the bad news to affected couples (setting, perception, invitation, knowledge, empathy, summary)

2. Respectful maternity careis to be ensured (dignity, freedom from harm, informed consent, refusal and confidentiality)

3. Making memories to remember the baby by means of creating handprints & footprints, holding the baby and taking photos.

4. Referral to the department of psychiatry, LHMC as and when mothers feel ready to talk about their grief.

5. Educating mothers about milk let down and milk donation and also giving them appropriate medications to prevent milk production.

6. Identification of the cause of stillbirthaccording to the ICD-10 PM classification and appropriate follow up will be done.

 A “Bereavement Care Guide” with checklist will be placed in the bereavement rooms to monitor the implementation of standard bereavement care. It will help identify which components are being followed, highlight any gaps, explore the underlying causes, and guide targeted interventions in the subsequent Plan, do, study , act (PDSA) cycles.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Day(s) 至 45.00 Day(s)(—)
性别
Female

入选标准

  • Women delivering stillborn babies.

排除标准

  • Women not willing to give consent to participate in the study.

结局指标

主要结局

Process measure:

时间窗: end of one year

Change in the mean utilization score of the bereavement care guide over 6 weeks.

时间窗: end of one year

Outcome measure:

时间窗: end of one year

Change in the mean satisfaction score of mothers delivering a stillborn over the period of study.

时间窗: end of one year

次要结局

  • Secondary outcome(The distribution of causes according to ICD -10 PM classification)

研究者

发起方
Dr Sarita Beri
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Manisha Kumar

Lady Hardinge Medical College

研究点 (1)

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