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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Reduce Unnecessary Caesarean Section, Increase Institutional Delivery, Increase Antenatal Care

Intervention / Treatment
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* Diagnostic Test: Ultrasonograpgy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the pregnant mothers irrespective of age who will be attending the designated hospitals/health complex. We will include all pregnant mothers who will have/have not complication to see the delivery outcome with indication of normal delivery and CS. Willing to participate in the study. Exclusion Criteria: Not willing to participate. Early Pregnancy with indication for C/S (co-morbidities, H/O previous C/S etc.)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (CG)<br>Usual care | |
| Experimental: Intervention Group (IG)<br>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<br>* 2 USG in 3rd and 5th ANC visits and even more USG if needed + 4 ANC + Health education<br>* Other names: Health Education;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean section, institutional delivery, ANC, Bangladesh