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OpenTrials
Completed

NCT Number: NCT00204139

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Johannesburg

Johannesburg, Gauteng, 2000, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Routine midtrimester pregnany ultrasound scan

Procedure

Primary outcomes

  1. Detection of congenital abnormalities

  2. Postterm pregnancy inductions

Secondary outcomes

  1. Detection of multiple pregnancies

  2. Stillbirths

  3. Neonatal morbidity

  4. Neonatal mortality

Sponsors and collaborators

Lead sponsor

University of Johannesburg

Other

Registry information

Important dates

Study start
2002
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Sep 20, 2005

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.

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