Clinical trial NCT05135026: Ultrasonography and Health Education Can Reduce the Unnecessary Caesarean Section in Bangladesh
Official title: Ultrasonography and Health Education During the Antenatal Visits Among the Pregnant Women to Reduce the Unnecessary Caesarean Section in a Resource Poor Setting (Bangladesh): a Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reduce Unnecessary Caesarean Section
Increase Institutional Delivery
Increase Antenatal Care
Keywords: Caesarean section
institutional delivery
ANC
Bangladesh
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: North South University
name: Obstetrical and Gynaecological Society of Bangladesh (OGSB), Bangladesh
First posted: 2021-11-26
Enrollment: 288
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: From the urban area \[Dhaka Medical College \& Hospital (DMCH) and Sir Salimullah Medical College \& Hospital (SSMCH)\], we will randomly select one hospital for intervention group and another hospital for the control group and from the rural area (Munsigonj General Hospital and Savar Upazila Health Complex), one hospital will be randomly selected as intervention site and other hospital will be selected as comparison site.
Primary purpose: TREATMENT

Brief summary: A caesarean section (C/S) is a surgical procedure performed to prevent difficulties during childbirth. World Health Organization considered the standard rate for the C/S would be between 10% and 15%. However, since 2000 the rate of C/S was increasing globally, and it became about twofold from 12.1% to 21.1% in 2015.

In Bangladesh, C/S continued to increase from 8% (2007) to 33% (2017). Medically unnecessary C/S was estimated about 77% of all C/S in 2018, and it was increased from 66% since 2016. In Bangladesh, unnecessary C/S observed 9.0% and 3.2% C/S done due to avoid labour pain and 5.8% for the convenience of the mother. The economic burden of each C/S is average USD 612 and unfortunately, each patient spends this amount of money from out of pocket. Aim of this study is to do ultrasonography and health education can reduce unnecessary caesarean section among pregnant women compared to control group in a resource poor setting.

Investigators will conduct this randomized controlled trial (RCT) at Dhaka and Sir Salimullah Medical College \& Hospital, and two rural Upazila Health Complexes (Savar Upazila Health Complex and Munshigonj General Hospital). Investigators will randomly select one urban hospital from two urban hospitals and one rural hospital from two rural hospitals for the intervention. The other one urban and one rural hospital will be assigned as control hospitals. One research staff, who will not involve any of the research activity of this trial, will do this randomization. Pregnant mothers will be identified and recruited during their routine antenatal visits. Pregnant mothers receive 2 USG during their routine ANC visits at 1st visit of 8-12 weeks and 4th visit of 36-38 weeks. In the intervention centres, Investigators will perform additional 4 ANC visits at 20, 30, 36 and 40 weeks (total 8 visits) and USG additional 2 times during the 2nd visit of 24-26 weeks and 5th visit of 34 weeks (2 routine USG + 2 USG in 3rd and 5th ANC visits and even more USG if needed + Health education; pictorial flip chart showing danger sign during pregnancy and potential risks for unnecessary caesarean delivery to increase awareness for safe delivery) for all the enrolled pregnant mothers. In the control centres, Investigators will collect information from the pregnant mothers.

Investigators are expecting the pregnant women who will receive antenatal care with ultrasonography and health education will have reduced number of unnecessary C/S compared to control group who will not receive those.


Eligibility criteria: Inclusion Criteria:

1. All the pregnant mothers irrespective of age who will be attending the designated hospitals/health complex.
2. We will include all pregnant mothers who will have/have not complication to see the delivery outcome with indication of normal delivery and CS.
3. Willing to participate in the study.

Exclusion Criteria:

1. Not willing to participate.
2. Early Pregnancy with indication for C/S (co-morbidities, H/O previous C/S etc.)

Primary outcomes:
measure: Unnecessary C/S
timeFrame: 36 weeks
Secondary outcomes:
measure: ANC
timeFrame: 36 weeks
measure: USG
timeFrame: 36 weeks
measure: Institutional (hospital and clinics) delivery compare to the home delivery
timeFrame: 36 weeks
measure: Delivery related complications
timeFrame: 36 weeks
measure: Rate of still birth
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: DMCH, SSMC, Munshiganj General Hospital and Bogra District Hospital
Study officials:
References:
citation: 1. World Health Organization 2015. WHO statement on caesarean section rates. https://apps.who.int/iris/bitstream/handle/10665/161442/WHO_RHR_15.02_eng.pdf?sequence=1 2. Boerma T, Ronsmans C, Melesse DY, Barros AJD, Barros FC, Juan L, Moller A-B, Say L, Hosseinpoor AR, Yi M, Neto DdeLR, Temmerman M. Global epidemiology of use of and disparities in caesarean sections. The Lancet, 2018; 392 (10155): 1341 DOI: 10.1016/S0140-6736(18)31928-7 3. Charvalho PdaS, Hansson BM, Stjernholm VY. Indications for increase in caesarean delivery. Reprod Health, 2019; 16, 72. https://doi.org/10.1186/s12978-019-0723-8 4. Bangladesh Demographic and Health Survey 2017-2018-key indicators.pdf [https://dhsprogram.com/pubs/pdf/PR104/PR104.pdf] 5. Save the Children International 2020. Bangladesh: 51 per cent increase in "unnecessary" C-sections in two years. [https://www.savethechildren.net/news/bangladesh-51-cent-increase-"unnecessary"-c-sections-two-years#_edn2] 6. BDHS 2014 final report[ https://dhsprogram.com/publications/publication-fr311-dhs-final-reports.cfm] 7. Infographic-unnecessary-caesarean-section.pdf[ https://www.who.int/reproductivehealth/publications/unnecessary-cs-infographics/en/] 8. Hasan F, Alam MM, Hossain MG. Associated factors and their individual contributions to caesarean delivery among married women in Bangladesh: analysis of Bangladesh demographic and health survey data. BMC Pregnancy Childbirth, 2019;19(1):433. doi:10.1186/s12884-019-2588-9 9. World Health Organization 2016. Pregnant women must be able to access the right care at the right time, says WHO. https://www.who.int/news-room/detail/07-11-2016-pregnant-women-must-be-able-to-access-the-right-care-at-the-right-time-says-who 10. Dowswell T, Carroli G, Duley L, Gates S, Gülmezoglu AM, Khan-Neelofur D, Piaggio G. Alternative versus standard packages of antenatal care for low-risk pregnancy. Cochrane Database Syst Rev. 2015;(7):CD000934 11. World Health Organization 2018. WHO recommendation on antenatal care contact schedules. https://extranet.who.int/rhl/topics/improving-health-system-performance/who-recommendation-antenatal-care-contact-schedules 12. Alland JYK, Ali H, Mehra S, LeFevre AE, Pak SE, Shaikh S, Christian P, Labrique AB. Antenatal care in rural Bangladesh: current state of costs, content and recommendations for effective service delivery. BMC Health Serv Res, 2019; 19, 861. https://doi.org/10.1186/s12913-019-4696-7 13. World Health Organization 2018. WHO recommendation on early ultrasound in pregnancy. https://extranet.who.int/rhl/topics/preconception-pregnancy-childbirth-and-postpartum-care/antenatal-care/who-recommendation-early-ultrasound-pregnancy 14. Ryan BL, Krishnan RJ, Terry A, Thind A. Do four or more antenatal care visits increase skilled birth attendant use and institutional delivery in Bangladesh? A propensity-score matched analysis. BMC Public Health, 2019;19(1):583. 15. Pervin J, Moran A, Rahman M, Razzaque A, Sibley L, Streatfield PK, Reichenbach LJ, Koblinsky M, Hruschka D, Rahman A. Association of antenatal care with facility delivery and perinatal survival - a population-based study in Bangladesh. BMC Pregnancy Childbirth, 2012;12:111. doi:10.1186/1471-2393-12-111 16. World Bank 2014. The World Bank Annual Report 2014. Washington, DC. © World Bank. https://openknowledge.worldbank.org/handle/10986/20093 License: CC BY-NC-ND 3.0 IGO. 17. Bangladesh_country_report.pdf [ https://www.who.int/pmnch/knowledge/publications/bangladesh_country_report.pdf] 18. Begum T, Ellis C, Sarker M, et al. A qualitative study to explore the attitudes of women and obstetricians towards caesarean delivery in rural Bangladesh. BMC pregnancy and childbirth, 2018;18(1):368. 19. The United Nations Children's Fund (UNICEF). Monitoring the situation of children and women. Maternal mortality, 2019. https://data.unicef.org/topic/maternal-health/maternal-mortality/ 20. Centers for Disease Control and Prevention (CDC). U.S. Department of Health & Human Services. https://www.cdc.gov/ncbddd/stillbirth/facts.html 21. Ylva Vladic Stjernholm. Caesarean section: reasons for and actions to prevent unnecessary caesareans. Open access peer-reviewed chapter. 2018. DOI: 10.5772/intechopen.76582. https://www.intechopen.com/chapters/63427 22. Charan J, Biswas T. How to calculate sample size for different study designs in medical research?. Indian J Psychol Med. 2013;35(2):121-126. doi:10.4103/0253-7176.116232