Condition category
Pregnancy and Childbirth
Date applied
25/09/2014
Date assigned
24/10/2014
Last edited
24/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is growing evidence that suggests that some women giving birth suffer disrespectful and abusive treatment at the hands of their health care providers and the health system in general. This includes, among other things, being shouted at, threats to withhold health care, physical abuse and leaving them to fend for themselves at time of need. This treatment violates the fundamental right of every woman to be treated with dignity within the health care system. It may stop women from seeking care at health facilities and undermine efforts to reduce the death rates of women who are having, or have recently had, a baby. Here, we want to identify the type of abuse experienced, the number of women affected, the root causes of the abuse and the consequences of it. We aim to develop and test a evidence-based programme to prevent this treatment from happening.

Who can participate?
Females aged at least 15 who have given birth in the last year and live in the immediate catchment areas of the study facilities, or who have been discharged after a delivery in a health facility in the study facilities.

What does the study involve?
This project is run in two districts of Tanga region in northeastern Tanzania: Korogwe district (intervention district) and Muheza district (comparison district). In order to measure just how widespread the problem is, all women who have given birth discharged from one of the study facilities over a particular 4 month period are invited for an interview to talk about their experiences. A random number of these women are then followed up 6-8 weeks later. Focus groups and in-depth interviews are used for formative research as well as to examine perspectives on the nature and causes of the problem. Independent observations of deliveries in two of the facilities are also done and the women discharged after birth given exit questionnaires. After the collection and analysis of this “baseline” data, the evidence-based programme (intervention) takes place over a 12-18 month period in the Korogwe district. This involves the adaptation of a patient-provider charter and a quality improvement process which involves taking steps to improve respectful care. Muheza District, the comparison, will be provided with the findings of the baseline research and participate only in the first planning meeting to interpret the data.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit for the participants at the time of interview, but there should be future benefits if we can identify ways to reduce disrespectful and abusive treatment of women during childbirth. There will be minimal risks to women who agree to participate in focus group discussions, exit questionnaires and follow-up interviews. Patients requiring support following talking about any experience of depression, physical abuse, and rape are referred to mental health nurses located at nearby hospitals. To prepare for potential situations where the study observers may deem the safety or life of the patient to be endangered or where despite adequate care, the patient is deteriorating, observers will call senior staff for assistance.

Where is the study run from?
The study is conducted by Columbia University Mailman School of Public Health,
Heilbrunn Department of Population and Family Health in partnership with the Ifakara Health Institute and local government in Korogwe and Muheza Districts of Tanzania.

When is the study starting and how long is it expected to run for?
February 2011 to June 2011

Who is funding the study?
The Ministry of Foreign Affairs, Denmark and the American people through the United States Agency for International Development (USAID) and its Translating Research into Action (TRAction) Project.

Who is the main contact?
Lynn Freedman
lpf1@columbia.edu

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lynn Freedman

ORCID ID

Contact details

Averting Maternal Death and Disability Program (AMDD)
Heilbrunn Department of Population and Family Health
Columbia University Mailman School of Public Health
60 Haven Ave
B3
New York
10032
United States of America
lpf1@cumc.columbia.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GG001823

Study information

Scientific title

The Staha Project: Promoting Respectful and Attentive Care in Tanzania. A Quasi-random, pre and post comparison group study

Acronym

Staha

Study hypothesis

This study hypothesizes that understanding the prevalence, nature, and severity of drivers of disrespect and abuse during childbirth will point to locally-feasible program activities which can reduce the incidence of this problem, thereby increasing health service utilization and ultimately improving maternal health outcomes.

Ethics approval

1. Columbia University (USA), 1/3/2011, ref. IRB-AAAI1341
2. Ifakara Health Institute (Tanzania), 5/3/2011, ref. IHI/IRB/No: 05
3. National Institute of Medical Research (Tanzania), 11/5/2011, ref. NIMR/HQ/R.8a/Vol.IX/144

Study design

Quasi-random, pre and post comparison group study.

Primary study design

Interventional

Secondary study design

Other

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Disrespect and abuse experienced by women while delivering in health care facilities

Intervention

The intervention process involves two main, interacting components:
1. The adaptation of a patient-provider charter
2. A quality improvement (QI) process in the maternity ward in the district hospital. The duration of the intervention will be 12-18 months

The patient-provider charter in Tanzania was adopted at the national level and written in broad terms for further adaptation at local levels. Similar to other settings, the charter was never implemented at national level or adapted at local level. A small group of stakeholders from different district boards will be chosen to review and adapt the charter for district level. Then, each study facility (n=4) will perform its own adaptation of the charter with communities within the facilities’ catchment areas. Community leaders and health system managers will take actions to fulfill their obligations, including support to health providers

Intervention facilities will partake in a facility-based, modified quality improvement process to improve respectful care. The maternity team will use both the baseline data from the Staha project and the standards emerging from the charter as the criteria. Each 1-3 months, the maternity team will choose a new practice to adopt in relation to these standards. They will then work to implement and measure change for the chosen standard. Participants will include all health facility staff that work in the maternity ward and, depending on the standard being addressed, will include staff from other relevant parts of the facility.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reported disrespect and abuse:
1. Single item measures:
1.1. Patient’s private health information shared in a way that others could hear
1.2. Patient’s private health information shared with others without patient’s consent
1.3. Lack of physical privacy
1.4. Shouting/scolding
1.5. Threat of withholding treatment
1.6. Threatening comments
1.7. Negative comments
1.8. Ignored when needed help
1.9. Delivered without attendant
1.10. Non-consent for tubal ligation
1.11. Non-consent for hysterectomy
1.12. Non-consent for cesarean section
1.13. Physical abuse (shouting, slapping, hitting, etc)
1.14. Sexual harassment
1.15. Rape
1.16. Detention in facility for failure to pay
1.17. Request for bribe

2. Categories of items:
2.1. Non-confidential care:
2.1.1. Patient’s private health information shared in a way that others could hear
2.1.2. Patient’s private health information shared with others without patient’s consent
2.1.3. Lack of physical privacy
2.2. Non-dignified care:
2.2.1. Shouting/scolding
2.2.2. Threat of withholding treatment
2.2.3. Threatening comments
2.2.4. Negative comments
2.3. Neglect:
2.3.1. Ignored when needed help
2.3.2. Delivered without attendant
2.4. Non-consented care:
2.4.1. Non-consent for tubal ligation
2.4.2. Non-consent for hysterectomy
2.4.3. Non-consent for cesarean section
2.5. Physical abuse:
2.5.1. Physical abuse (shouting, slapping, hitting, etc)
2.5.2. Sexual harassment
2.5.3. Rape
2.6. Inappropriate demands for payment:
2.6.1. Detention in facility for failure to pay
2.6.2. Request for bribe

3. Overall indicator:
Any reported disrespect and abuse: answering “yes” to any of the single item questions

Secondary outcome measures

1. Facility utilization
2. Satisfaction with delivery
3. Satisfaction with the health system
4. Perceived quality of care
5. Postpartum depression
6. Health seeking behaviors for mother, infant and other children postpartum
7. Recommendation of facility
8. Use of facility for child health visits
9. Intention to use same facility for next delivery
10. Intention to have more children
11. Self-rated health status

Overall trial start date

28/02/2011

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Exit interviews: All women 15 years or older discharged after a delivery in the study facilities during a four month period
2. Community follow-up interviews: Women randomly selected from those who complete an exit interview and consent to a follow-up interview in their home
3. Observations: Women who deliver at the 2 study hospitals and the health providers in the maternity wards during the month of observation
4. Qualitative interviews: health providers, community members, health managers, local government officials, regional and national health system stakeholders

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Facility exit questionnaires: 1468 women; Follow-up interviews: 500 women; Observations: 200 deliveries

Participant exclusion criteria

N/A

Recruitment start date

28/02/2011

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Tanzania

Trial participating centre

Averting Maternal Death and Disability Program (AMDD)
New York
10032
United States of America

Sponsor information

Organisation

Columbia University Mailman School of Public Health (USA)

Sponsor details

c.o. Lynn Freedman
Averting Maternal Death and Disability Program (AMDD)
Heilbrunn Department of Population and Family Health
Columbia University Mailman School of Public Health
60 Haven Ave
B3
New York
10032
United States of America
lpf1@cumc.columbia.edu

Sponsor type

Government

Website

http://www.amddprogram.org

Funders

Funder type

Other

Funder name

Ministry of Foreign Affairs (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United States Agency for International Development (USAID) and its Translating Research into Action (TRAction) Project (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes