DMCH, SSMC, Munshiganj General Hospital and Bogra District Hospital
Dhaka, Bangladesh
NCT Number: NCT05135026
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 (Bogra 250-bed Mohammad Ali District Hospital) 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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Interventional
Not applicable
Dhaka, Bangladesh
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
2 USG in 3rd and 5th ANC visits and even more USG if needed + 4 ANC + Health education
Other names: Additional 4 ANC, Health Education
Time frame: 36 weeks
Compare the reduction of the percentage of unnecessary C/S among the intervention compare to control pregnant women
Time frame: 36 weeks
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.)
Time frame: 36 weeks
The rate of set-number (4 times) of USG use among the intervention pregnant women (how many pregnant women in IG followed the protocol.)
Time frame: 36 weeks
The rate of the institutional (hospital and clinics) delivery among the intervention pregnant women, compared with CG.
Time frame: 36 weeks
The reduction rate of the delivery related complications [ante partum and postpartum haemorrhage (APH, PPH)] among the intervention pregnant women, compared with CG
Time frame: 36 weeks
The reduction rate of still birth among the intervention pregnant women, compared with CG.
Hiroshima University
Other
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
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