Fetal Congenital AbnormalitiesPhase 3NCT00204139
Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting: a Cluster Randomised Controlled Trial
A Phase 3 study testing Routine midtrimester pregnany ultrasound scan in people with Fetal Congenital Abnormalities and Prolonged Pregnancy, run by University of Johannesburg at 1 site in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Congenital Abnormalities, Prolonged Pregnancy, Multiple Pregnancy
- What is being tested?
- Routine midtrimester pregnany ultrasound scan
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2002to May 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy, 24 weeks pregnant or less, willing to participate
Who cannot join
- High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2000
About this study
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.
Read the 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.
- Being tested
- Routine midtrimester pregnany ultrasound scan
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine midtrimester pregnany ultrasound scanProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of congenital abnormalities
Postterm pregnancy inductions
Secondary outcomes (4)
Detection of multiple pregnancies
Stillbirths
Neonatal morbidity
Neonatal mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2002
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Congenital AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Investigators
- Eckhart J Buchmann, MBBCh, Study chair, University of the Witwatersrand, Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204139
- Sponsor's protocol ID
- BvanDyk USS
- Status last verified
- Jul 2004
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting: a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00204139
- Acronym / sponsor ID
- BvanDyk USS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Jun 2002
- Study completion
- May 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnancy, 24 weeks pregnant or less, willing to participate
Key exclusion criteria (1 listed)
- High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine midtrimester pregnany ultrasound scan | Procedure or surgery | – |
Primary outcome
Detection of congenital abnormalities
Postterm pregnancy inductions
4 secondary outcomes
Detection of multiple pregnancies
Stillbirths
Neonatal morbidity
Neonatal mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eckhart J Buchmann, MBBCh study chair
University of the Witwatersrand, Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Routine midtrimester pregnany ultrasound scan in people with Fetal Congenital Abnormalities and Prolonged Pregnancy, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of congenital abnormalities. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.