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NCT Number: NCT05135026

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

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DMCH, SSMC, Munshiganj General Hospital and Bogra District Hospital

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the pregnant mothers irrespective of age who will be attending the designated hospitals/health complex in their first trimester.
  • 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.) in their first trimester.

Treatment and study plan

Ultrasonograpgy

Diagnostic Test

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

Primary outcomes

  1. Unnecessary C/S

    Time frame: 36 weeks

    Compare the reduction of the percentage of unnecessary C/S among the intervention compare to control pregnant women

Secondary outcomes

  1. ANC

    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.)

  2. USG

    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.)

  3. Institutional (hospital and clinics) delivery compare to the home delivery

    Time frame: 36 weeks

    The rate of the institutional (hospital and clinics) delivery among the intervention pregnant women, compared with CG.

  4. Delivery related complications

    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

  5. Rate of still birth

    Time frame: 36 weeks

    The reduction rate of still birth among the intervention pregnant women, compared with CG.

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • North South University
  • Obstetrical and Gynaecological Society of Bangladesh (OGSB), Bangladesh

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 26, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.