Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000268246
Ethics application status
Approved
Date submitted
10/03/2009
Date registered
15/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of antenatal birth plans in increasing skilled care at delivery and after delivery in rural Tanzania
Scientific title
The effectiveness of antenatal birth plans in increasing skilled care at delivery and after delivery in rural Tanzania
Secondary ID [1] 853 0
Nil
Secondary ID [2] 854 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 4445 0
Condition category
Condition code
Reproductive Health and Childbirth 4714 4714 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Antenatal care model in which birth plans will be introduced, promoted and emphasized in the intervention health units during antenatal clinic visits through provider- participant dialogue and will be performed during routine antenatal care visits as per national guidelines (attendance four times in pregnancy for women with no pregnancy complications –preferably the first visit before 16 weeks, second visit at around 28 weeks, 3rd visit between 32-34 weeks and the 4th visit at around 36 weeks). Parallel to the national level, the median gestation age at first antenatal attendance is at six month and it is thus expected that most women will attend three times at most: initial visit at six months, second visit between seven and eight months and the last at nine months. The consultation time for each woman will be approximately 40 minutes at initial attendance and for approximately 15 minutes during the subsequent visits. The provider-participant dialogue will be on preparations for normal birth by identifying a skilled birth attendant and place of delivery, transport arrangement to reach the place of delivery or emergency care, financial arrangements to pay for transport and services, knowledge of where and to whom to go for help. The other discussions will be on the knowledge of danger signs during pregnancy, labour, delivery and postpartum for the mother and newborn and when to seek help when a complication arises, support in looking after the home and children while the woman is away, identification of a birth companion and identification of compatible blood donors. The dialogue will be on-going throughout the attendances and will start during the initial visit and end at the last visit when plans that have been formulated and those that have been completed will be documented by the care provider. Participants’ male partners will also be invited to participate in the dialogue. Two copies of the formulated/completed plans will be made and one given to the woman to keep and show up at a health unit she will seek delivery care. The remaining copy will be kept by the provider.
Intervention code [1] 4191 0
Other interventions
Comparator / control treatment
Antenatal care as currently provided by care providers in the district which follows the focused antenatal care
protocol as advocated by the World Health Organization (WHO)
Control group
Active

Outcomes
Primary outcome [1] 5888 0
Proportion of women enrolled in the study who deliver in the available health units. Each unit will be provided with a delivery record sheet in which all women in the study who will deliver in the unit are documented. Subsequently, the information will be used to ascertain the women?s delivery sites. In addition women will be asked for their places of delivery during the postpartum interview.
Timepoint [1] 5888 0
delivery
Secondary outcome [1] 241919 0
Proportion of women who finalize the birth plans (formulated/completed forms at all intervention units)
Timepoint [1] 241919 0
delivery
Secondary outcome [2] 241920 0
proportion of women who attend postpartum care within one month after delivery (to be documented on the post natal interview one month after delivery and from health units? record)
Timepoint [2] 241920 0
one month after delivery
Secondary outcome [3] 241921 0
level of satisfaction with antenatal care among participants and providers as measured on a modified five point Likert?s scale (to be documented during the intervention implementation stage interview to both antenatal attendees and their respective providers)
Timepoint [3] 241921 0
during pregnancy

Eligibility
Key inclusion criteria
All pregnant women attending antenatal care at health units in the district who will consent to participate in the study and meet the inclusion criteria of confirmed pregnancy by clinical palpation, resident of the district, those planning to deliver in the district and those not already referred to the available hospitals for specialized care for various reasons.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women with a gestational age beyond 34 weeks and/or women planning to deliver outside the district.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a cluster randomized controlled trial in a health care setting. 18 health units in the district will be randomly assigned to the intervention (antenatal care with emphasis on birth plans) and control (antenatal care as currently provided). All consented women in the clusters (health units) at least 24 weeks gestation will be recruited into the study. The names of all health units (clusters) will be sent to London where randomization into either the intervention or control arms will be done by an off the site statistician. Study sites (clusters) allocation will thus be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
760
Accrual to date
Final
Recruitment outside Australia
Country [1] 1661 0
Tanzania, United Republic Of
State/province [1] 1661 0
Ngorongoro

Funding & Sponsors
Funding source category [1] 4638 0
Charities/Societies/Foundations
Name [1] 4638 0
World Health Organization
Country [1] 4638 0
Switzerland
Primary sponsor type
Charities/Societies/Foundations
Name
World Health Organization
Address
Avenue Appia 20 - 1211 Geneva
Country
Switzerland
Secondary sponsor category [1] 4182 0
University
Name [1] 4182 0
London School of Hygiene & Tropical Medicine
Address [1] 4182 0
Keppel Street, London, WC1 7HT
Country [1] 4182 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6676 0
WHO Ethics Review Committee
Ethics committee address [1] 6676 0
Avenue Appia 20 - 1211 Geneva
Ethics committee country [1] 6676 0
Switzerland
Date submitted for ethics approval [1] 6676 0
Approval date [1] 6676 0
25/03/2008
Ethics approval number [1] 6676 0

Summary
Brief summary
Justification for the project:
Birth plans are conceptually compelling as a safe motherhood strategy to increase killed care at delivery and immediately after, but robust empirical evidence is lacking to support their effectiveness. The proposed study meets the United Nations Depelopment Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) research objectives of improving maternal and perinatal health by generating evidence of effectiveness of
interventions currently promoted through providing evidence for the effectiveness of birth plans (or lack thereof) to increase skilled care at delivery and after delivery as a strategy to reduce maternal and perinatal mortality.
Proposed Research:
In most developing countries including Tanzania, many more women attend antenatal care than deliver under care of skilled providers in health care settings. Having skilled delivery care providers at birth provides prompt and effective way of managing serious complications as they arise in order to reduce most maternal deaths.
Birth plans are one of the components of focused antenatal care in many developing countries and is promoted as a strategy to increase skilled care at delivery. However, robust empirical evidence lacks to support the effectiveness of birth plans to increase skilled delivery care. A cluster randomized controlled trial will be conducted in 18 health
units involving at least 760 women in Ngorongoro district, rural Tanzania to determine the effectiveness of birth plans in increasing skilled care at delivery and after delivery. 18 health units will be randomly assigned to provide antenatal care with renewed emphasis in birth plans (intervention) provided by care providers or control (antenatal care as currently provided). The district has over 6000 annual deliveries. Women will be interviewed twice, at first encounter and one month after delivery. Variables to be collected will be on sociodemographic characteristics, obstetric history (past and present), components of antenatal care provided, barriers to skilled delivery care utilization and care satisfaction. The primary outcome will be the proportional of women who will seek delivery at the available health units. The proportion of women who will seek post delivery care and care satisfaction as measured on a five point Likert’s scale will be the secondary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29373 0
Address 29373 0
Country 29373 0
Phone 29373 0
Fax 29373 0
Email 29373 0
Contact person for public queries
Name 12620 0
Dr Moke Magoma
Address 12620 0
P.O.Box 12870 ARUSHA
Country 12620 0
Tanzania, United Republic Of
Phone 12620 0
+44 20 7958 8172 / +255 754 284 691
Fax 12620 0
+44 20 7637 4314
Email 12620 0
moke.magoma@lshtm.ac.uk
Contact person for scientific queries
Name 3548 0
Dr Moke Magoma
Address 3548 0
P.O.Box 12870 ARUSHA
Country 3548 0
Tanzania, United Republic Of
Phone 3548 0
+44 20 7958 8172 / +255 754 284 691
Fax 3548 0
+44 20 7637 4314
Email 3548 0
moke.magoma@lshtm.ac.uk

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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