Ultrasonography and Health Education Can Reduce the Unnecessary Caesarean Section in Bangladesh

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

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.

Study Overview

• Status: Recruiting
• Conditions: Reduce Unnecessary Caesarean Section; Increase Institutional Delivery; Increase Antenatal Care
• Intervention / Treatment: Diagnostic test: Ultrasonograpgy

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Delwer Hossain Hawlader, MBBS MPH PhD; Phone Number: 2297 +88-02-55668200; Email: mohammad.hawlader@northsouth.edu
• Study Contact Backup: Name: Michiko Moriyama, RN MSN Ph.D; Phone Number: +81-82-257-5365; Email: morimich@hiroshima-u.ac.jp

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Recruiting
    • DMCH, SSMC, Munshiganj General Hospital and Bogra District Hospital
    • Principal Investigator: Mohammad Delwer Hossain Hawlader, MBBS MPH PhD
    • Principal Investigator: Habiba Shirin, MBBS DMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (CG); Usual care
Experimental: Intervention Group (IG); In the intervention hospitals, we will perform USG additional 2 times during the 3rd visit of 24-26 weeks and 5th visit of 34 weeks (2 USG and even more USG if needed + additional 4 ANC + 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 enolled pregnant mothers.	Diagnostic test: Ultrasonograpgy; 2 USG in 3rd and 5th ANC visits and even more USG if needed + 4 ANC + Health education; Other Names: Health Education; Additional 4 ANC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unnecessary C/S	Compare the reduction of the percentage of unnecessary C/S among the intervention compare to control pregnant women	36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ANC	The rate of set-number (8 times) of ANC and post-natal (PNC) visits rates among the intervention pregnant women (how many pregnant women in IG followed the protocol.)	36 weeks
USG	The rate of set-number (4 times) of USG use among the intervention pregnant women (how many pregnant women in IG followed the protocol.)	36 weeks
Institutional (hospital and clinics) delivery compare to the home delivery	The rate of the institutional (hospital and clinics) delivery among the intervention pregnant women, compared with CG.	36 weeks
Delivery related complications	The reduction rate of the delivery related complications [ante partum and postpartum haemorrhage (APH, PPH)] among the intervention pregnant women, compared with CG	36 weeks
Rate of still birth	The reduction rate of still birth among the intervention pregnant women, compared with CG.	36 weeks

Collaborators and Investigators

• Sponsor: Hiroshima University
• Collaborators: North South University; Obstetrical and Gynaecological Society of Bangladesh (OGSB), Bangladesh

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Caesarean section; Bangladesh; institutional delivery; ANC
• Other Study ID Numbers: 2021/OR-NSU/IRB/0804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No