NCT05135026

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

Status unknown NA Last updated 23 August 2022

What this trial tests

NA trial testing Ultrasonograpgy in Reduce Unnecessary Caesarean Section in 288 participants. Status unknown.

Timeline

28 November 2021

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Hiroshima University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	288
Start date	28 November 2021
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	1 location across Bangladesh

Drugs / interventions tested

• Ultrasonograpgy

Conditions studied

• Reduce Unnecessary Caesarean Section — all drugs for Reduce Unnecessary Caesarean Section →
• Increase Institutional Delivery — all drugs for Increase Institutional Delivery →
• Increase Antenatal Care — all drugs for Increase Antenatal Care →

Sponsor

Hiroshima University

Who can join

Eligibility, female only, with Reduce Unnecessary Caesarean Section or Increase Institutional Delivery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of WHO-recommended antenatal care visits, ultrasonography, and health education in reducing unnecessary caesarean sections among pregnant women in Bangladesh: a hospital-based randomised controlled trial.
   Shirin H, K A T M Ehsanul H, Hawlader MDH, Masud SB, et al · · 2025 · cited 1× · PMID 40576427 · DOI 10.7189/jogh.15.04182
2. 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.
   Shirin H, Moriyama M, Huq KATME, Rahman MM, et al · · 2022 · cited 1× · PMID 36548143 · DOI 10.3390/mps5060101