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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-28

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Reduce Unnecessary Caesarean Section Increase Institutional Delivery Increase Antenatal Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

One research staff, who will not be involved any of the research activity of this trial, will do this randomization.

Study Groups

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Control Group (CG)

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Ultrasonograpgy

Intervention Type DIAGNOSTIC_TEST

2 USG in 3rd and 5th ANC visits and even more USG if needed + 4 ANC + Health education

Interventions

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Ultrasonograpgy

2 USG in 3rd and 5th ANC visits and even more USG if needed + 4 ANC + Health education

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Additional 4 ANC Health Education

Eligibility Criteria

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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.