UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031789
Receipt No. 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 (Ver. 8)

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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
Email 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
Email gai-r@ncchd.go.jp

Sponsor
Institute Japan International Cooperation Agency
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036286