Association of Ultrasonography and Health Education during Antenatal Visits among Pregnant Women to Reduce Unnecessary Caesarean Section in Bangladesh: Study Protocol for a Cluster Randomized Control Trial
2. Materials and Methods
2.1. Trial Design
2.2. Study Setting
2.3. Study Participants
2.4. Inclusion Criteria
2.5. Operational Definition of Term
2.6. Recruitment Procedure, Obtaining Consent and Checking Eligibility
2.7. Allocation and Randomization
2.8. Health Education Materials
2.9. Quality Control and Quality Assurance for Data Management
2.10. Training of Study Staff
2.11. Data Collection and Entry Procedures
2.12. Sample Size
2.13. Statistical Analyses
2.14. Strengths and Limitations of This Study
- As this is a multicenter study, it will give us a broader understanding of the risk factors related to unnecessary C/S and will minimize biases.
- For resource poor low-and-middle income countries, this study’s findings will give significant economic relief to pregnant mothers by preventing unnecessary C/S and reduce hospital costs and infections.
- The study findings will have a significant impact in reducing maternal and childhood morbidity and mortality and increase the potential of achieving the Sustainable Development Goal (SDGs) by 2030.
- According to the study design, pregnant women maybe admitted to any of the hospitals according to their choice. As there are many public-private hospitals and clinics in the study areas, we could not involve all the gynecologists and obstetricians from the study area in our study. According to World Health Organization, there are roles played by gynecologist and obstetrician in C/S, and the outcome might be influenced by these in terms of their decisions to perform C/S.
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Shirin, H.; Moriyama, M.; Huq, K.A.T.M.E.; Rahman, M.M.; Masud, S.B.; Begum, R.A.; Misty, K.; Hawlader, M.D.H. Association of Ultrasonography and Health Education during Antenatal Visits among Pregnant Women to Reduce Unnecessary Caesarean Section in Bangladesh: Study Protocol for a Cluster Randomized Control Trial. Methods Protoc. 2022, 5, 101. https://doi.org/10.3390/mps5060101
Shirin H, Moriyama M, Huq KATME, Rahman MM, Masud SB, Begum RA, Misty K, Hawlader MDH. Association of Ultrasonography and Health Education during Antenatal Visits among Pregnant Women to Reduce Unnecessary Caesarean Section in Bangladesh: Study Protocol for a Cluster Randomized Control Trial. Methods and Protocols. 2022; 5(6):101. https://doi.org/10.3390/mps5060101Chicago/Turabian Style
Shirin, Habiba, Michiko Moriyama, K.A.T.M. Ehsanul Huq, Md Moshiur Rahman, Sumaya Binte Masud, Rowshan Ara Begum, Kamrunnahar Misty, and Mohammad Delwer Hossain Hawlader. 2022. "Association of Ultrasonography and Health Education during Antenatal Visits among Pregnant Women to Reduce Unnecessary Caesarean Section in Bangladesh: Study Protocol for a Cluster Randomized Control Trial" Methods and Protocols 5, no. 6: 101. https://doi.org/10.3390/mps5060101