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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Gulsah
Cetinkaya
gulsah.cetinkaya1@nhs.net
Nishel
Shah
nishel.shah@imperial.ac.uk
Prof
Mark
Johnson
mark.johnson@imperial.ac.uk
Maternal care related to the fetus and amniotic cavity and possible delivery problems
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Preterm birth (less than 37 weeks) affect approximately 8% of babies in the UK and is the worldwide leading cause of death in children under the age of 5. Subclinical infection affects approximately 50% of women giving birth before 32 weeks. Infection contributes to significant neonatal morbidity and mortality. Antibiotics such as erythromycin is currently used to treat women who present with preterm rupture of membranes. While this has shown short-term improvement in neonatal morbidity,it has not had any impact in reducing the perinatal mortality and also little effect on the health of the children at age seven. Some antibiotics such as co-amoxiclav has not shown to be effective in delaying delivery and some studies have shown that antibiotics increases rather than reduces the risk of cerebral palsy. Many women do not display signs of infection and the underlying bacteria is multifactorial (bacterial vaginosis,trichomoniasis,gonorrhoea,Chlamydia,ureaplasma,Group B streptococcal and E. Coli) and remains a diagnostic challenge. The only available clinical approach is to test the sample of amniotic fluid for bacteria and small case series have shown prolongation of pregnancy when accurately targeted antibiotic treatment is used.
This research aims to prove that targeted antibiotic therapy results in a greater prolongation of pregnancy than standard management for women with preterm pre-labour rupture of membranes (PPROM) and/or threatened preterm labour (tPTL).
Women will be randomised to standard care versus BioFire directed antibiotic treatment in addition to standard care. We will use the BioFire point of care testing to identify the presence of infection and identify with anti-microbial resistance genes the bacteria possess to guide the antibiotic treatment. To be certain that we detect the presence of infection we will use PCR to test the amniotic fluid for IL-6 and white cell count.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Management of Care;
You can take part if:
You may not be able to take part if:
Participants who meet any of the following exclusion criteria are not to be enrolled in this study. 1. Chorioamnionitis: Defined as maternal temperature was elevated to 37.8 °C and two or more of the following criteria were present: uterine tenderness,malodorous vaginal discharge,maternal leucocytosis (>15 000 cells/mm3),maternal tachycardia (>100 beats/min) and fetal tachycardia (>160 beats/min). 2. Multiple pregnancy 3. Uterine contractions >2:10 and evidence on tocogram 4. Maternal infections such as HIV and hepatitis 5. Clinical suspicion of placental abruption 6. Evidence of meconium stained liquor 7. Fetal abnormality or growth restriction 8. Abnormal fetal heart rate pattern 9. Maternal pathologies in which preterm termination of pregnancy is required. 10. Participants who smoke,drink alcohol or take recreational drugs
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Nishel
Shah
nishel.shah@imperial.ac.uk
Gulsah
Cetinkaya
gulsah.cetinkaya1@nhs.net
Prof
Mark
Johnson
mark.johnson@imperial.ac.uk
The study is sponsored by CHELSEA AND WESTMINSTER HOSPITAL NHS FOUNDATION TRUST and funded by THE BORNE FOUNDATION .
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for Trial ID: CPMS 54950
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