UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031789 |
|---|---|
| Receipt number | R000036286 |
| Scientific Title | Interventional study on the impact of safe motherhood promotion project Phase II in Bangladesh |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2019/09/20 12:32:11 |
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Basic information
Public title
Interventional study on the impact of safe motherhood promotion project Phase II in Bangladesh
Acronym
JICA SMPP II in Bangladesh
Scientific Title
Interventional study on the impact of safe motherhood promotion project Phase II in Bangladesh
Scientific Title:Acronym
JICA SMPP II in Bangladesh
Region
| Asia(except Japan) |
Condition
Condition
Maternal and neonatal health indicators
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of SMPP intervention in Kalaroa Upazila, Satkhira District on improving maternal and neonatal indicators and service utilization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- Proportion of targeted women (recently delivered women) received 4 or more ANC by skilled providers;
- Proportion of deliveries attended by skilled birth attendants
- Proportion of deliveries conducted at the health facilities (both public and private)
- Proportion of women with complications during pregnancy/delivery/postpartum period utilized EmOC services (met need)
- Proportion of targeted women received PNC within 42 days of delivery by skilled providers
- Proportion of mother&babies received neonatal care services from trained health providers (or health facilities) during neonatal sickness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Safe Motherhood Promotion through organizing communities,
Improvement of quality MNH services at hospitals,
Collaboration with local government bodies to mainstream MNH,
Replication and policy development of good practices related to MNH
Interventions/Control_2
The current service package
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Women who had child birth during last one year in the targeted areas.
Key exclusion criteria
Not willing to participate in the project
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Yukie |
| Middle name | |
| Last name | Yoshimura |
Organization
Japan International Cooperation Agency
Division name
Bangladesh Office
Zip code
1212
Address
3rd Floor, Bay's Galleria, 57 Gulshan Avenue, Gulshan 1, Dhaka 1212, Bangladesh
TEL
+880-2-989-1897
yoshiboubd@gmail.com
Public contact
Name of contact person
| 1st name | Ruoyan |
| Middle name | |
| Last name | Gai |
Organization
National Center for Child Health and Development
Division name
Department of Health Policy
Zip code
1578535
Address
Okura 2-10-1, Setagaya, Tokyo
TEL
+81.3.3416.0181
Homepage URL
gai-r@ncchd.go.jp
Sponsor or person
Institute
Japan International Cooperation Agency
Institute
Department
Personal name
Funding Source
Organization
Japan International Cooperation Agency (JICA)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
Okura 2-10-1, Setagaya-ku, Tokyo 1578535 Japan
Tel
0334160181
gai-r@ncchd.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394907/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394907/
Number of participants that the trial has enrolled
4675
Results
The major indicators of the utilization of maternal and neonatal care among pregnant women with different wealth status showed significant improvement after the intervention. The impacts of the intervention were in particular significant among the women of 2nd and 3rd quintiles of household wealth status. The use of CCs increased after the intervention and private hospitals / clinics served as the major health providers. The study also identified increased practices of cesarean section.
Results date posted
| 2019 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 28 | Day |
Baseline Characteristics
The study participant eligibility criteria was: women who had a birth during one year preceding the baseline and end-line data collection, resided in the intervention and control areas, and agreed to participate in the study with the written informed consent.
Participant flow
The two surveys collected data from 2,339 and 2,336 women who reside in Kalaroa upazila and gave birth in the preceding year of data collection (between 1 June 2011 and 31 May 2012 and between 1 July 2014 and 30 June 2015, respectively). The unit of randomization in this study was a CC in unions (the lowest administrative unit of local government) that covers about 6,000 population in its catchment area.
Adverse events
Not applicable
Outcome measures
The expected outcome of this study was increased utilization of services for antenatal, delivery, postpartum and neonatal care by the pregnant and post-partum women. We examined the proportion of women received those services provided by skilled health personnels including Community-based Skilled Birth Attendants (CSBA), Family Welfare Visitors (FWV), nurses and doctors, and at health facilities (both public and private).
The major indicators of the expected outcomes were:
- Proportion of women received any and 4+ ANC from skilled health care providers;
- Met need (proportion of women with complications received services from EmOC facilities) during pregnancy, childbirth and post-partum period;
- Delivery attended by skilled birth attendants;
- Delivery conducted at health facilities;
- Proportion of postpartum women received PNC from skilled providers within 42 days of delivery;
- Proportion of sick newborns received services from skilled provider.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2011 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036286
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
