Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting: a Cluster Randomised Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
University of Johannesburg
ClinicalTrials.gov Identifier:
NCT00204139
First received: September 12, 2005
Last updated: NA
Last verified: July 2004
History: No changes posted
  Purpose

It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of pregnancy has substantive benefits for mothers and babies. Few studies have addressed this issue in poorly resourced settings. This trial will attempt to determine the benefits, if any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no routine (only selective) scanning. This will be done by recruiting about 900 women in South Africa, and randomly allocating about half to routine scanning and half to selective scanning groups, and following up their pregnancies.


Condition Intervention Phase
Fetal Congenital Abnormalities
Prolonged Pregnancy
Multiple Pregnancy
Procedure: Routine midtrimester pregnany ultrasound scan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Johannesburg:

Primary Outcome Measures:
  • Detection of congenital abnormalities
  • Postterm pregnancy inductions

Secondary Outcome Measures:
  • Detection of multiple pregnancies
  • Stillbirths
  • Neonatal morbidity
  • Neonatal mortality

Estimated Enrollment: 900
Study Start Date: June 2002
Estimated Study Completion Date: May 2004
Detailed Description:

Routine ultrasound scanning in the second trimester of pregnancy has few substantive benefits, according to the results of number of randomised trials, mostly performed in industrialised countries. While ultrasound did not seem to prevent fetal death, it was associated with improved detection of multiple pregnancies, improved detection of congenital abnormalities and reduced need for postterm labour induction. Only one trial, from Cape Town, has investigated the benefits of a policy of routine second trimester ultrasound scanning in an under-resourced setting.

This will be cluster randomised controlled trial, performed in the Krugersdorp area of South Africa, where most health service users are African, working class and dependent on government health facilities. About 900 low-risk pregnant women at less than 24 weeks gestation will be recruited, and randomised, in clusters, to either routine scanning or no scanning with recourse to selective scanning if clinically indicated.

Women will be followed up for maternal, fetal and neonatal outcome, and for indices of health service utilisation. Important outcome measures will be need for subsequent ultrasound,detection of multiple pregnancy, detection of congenital abnormalities, postterm pregnancy induction, still birth,and neonatal morbidity and mortality.

Data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done, using standard statistical methods.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnancy, 24 weeks pregnant or less, willing to participate

Exclusion Criteria:

  • High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204139

Locations
South Africa
University of Johannesburg
Johannesburg, Gauteng, South Africa, 2000
Sponsors and Collaborators
University of Johannesburg
Investigators
Study Chair: Eckhart J Buchmann, MBBCh University of the Witwatersrand, Johannesburg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204139     History of Changes
Other Study ID Numbers: BvanDyk USS
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: South Africa: National Health Research Ethics Council

Additional relevant MeSH terms:
Congenital Abnormalities
Pregnancy, Prolonged
Pregnancy Complications

ClinicalTrials.gov processed this record on July 20, 2014