Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPGS 757
Study information
Scientific title
Acronym
Study hypothesis
The project is an RCT of the effect of first trimester ultrasound on rates of induction of labour for postdates. Currently it is widespread practice in most obstetric units in the United Kingdom to induce labour 14 days after the estimated date of delivery (EDD). While this has been shown to have a beneficial effect on perinatal outcome, it may cause consumer dissatisfaction as it is perceived to be a painful intervention in an otherwise normal pregnancy. Measurement of the biparietal diameter at 20 weeks gestation has been shown to improve the accuracy of gestational age assessment, and this should lead to a reduction in rates of induction of labour for postdates. Gestational age assessment using CRL in the 1st trimester is more accurate than the biparietal diameter and may further reduce the numbers requiring induction for postdates. There is an increasing shift to perform prenatal diagnosis in the first trimester. Those providing antenatal care may have to choose the best time at which a routine scan in pregnancy can be offered. If a first trimester ultrasound scan is shown to improve the customisation and therefore the appropriateness of obstetric care this would provide further evidence to justify its introduction as well as its use in screening for Down's syndrome, either with nuchal fold or as an adjunct to serum screening.
The objective is to determine whether an ultrasound scan in the first trimester of pregnancy will lead to more accurate assessment of gestational age and consequently lead to a reduction in the number of pregnancies induced at term and fourteen days. If this is the case then there will be cost savings for the NHS, as well as the reduction in unnecessary and potentially painful interventions.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and childbirth: Childbirth
Intervention
The control group will continue with routine antenatal care with ultrasound performed for the usual indications.
The intervention group will have an ultrasound scan between 8 and 12 weeks gestation to measure the crown-rump length (CRL) and if there is a discrepancy of greater than 5 days between the estimated date of delivery (EDD) calculated form the last menstrual period and that by CRL the EDD will be revised to that derived by scan. The EDD will be entered in the patient's obstetric notes and all subsequent management decisions will be based on this assessment of gestational age.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Rates of induction of labour for postdates
Secondary outcome measures
1. The characteristics of labour with respect to the length of labour, the mode of delivery, the immediate perinatal outcome, analgesic requirements for labour and the overall client satisfaction with labour
2. Rates of gestation dependent events in pregnancy - false positive and negative outcomes from maternal serum screening
3. The management of early pregnancy complications
Overall trial start date
01/02/1999
Overall trial end date
30/09/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women in the first trimester of pregnancy who do not require a first trimester ultrasound for any other clinical indication.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Added December 2008: 800 intended
Participant exclusion criteria
Women will be excluded if there is a clinical indication for a first trimester ultrasound scan or if they refuse consent. Examples of the former would be if there was vaginal bleeding, uncertainty about viability of the pregnancy or the possibility of an ectopic pregnancy.
Recruitment start date
01/02/1999
Recruitment end date
30/09/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Department of Obstetrics and Gynaecology
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results of uncompleted trial on http://www.ncbi.nlm.nih.gov/pubmed/16411994
Publication citations
-
Results of uncompleted trial
Harrington DJ, MacKenzie IZ, Thompson K, Fleminger M, Greenwood C, Does a first trimester dating scan using crown rump length measurement reduce the rate of induction of labour for prolonged pregnancy? An uncompleted randomised controlled trial of 463 women., BJOG, 2006, 113, 2, 171-176, doi: 10.1111/j.1471-0528.2005.00833.x.