Q1. Are women with a previous caesarean section eligible?
Having a previous caesarean section is not an exclusion criteria for the Big Baby Trial. It is the decision of the obstetrician in charge of the patients care to confirm if they are happy for the woman to enter the trial. If they confirm they are happy for their patient to enter the trial, they will need to sign in the red box in the essential recruitment document.
Q2. Are women who are diagnosed with GDM but are controlled with diet alone eligible? Would they become ineligible if they needed oral medication/insulin at any point?
If at randomisation the woman has GDM which is diet controlled she is eligible to join the trial. If at randomisation the woman has GDM requiring oral medication and/or insulin she would be ineligible. If after randomisation the woman then needed oral medication and/or insulin, she can continue in the trial and will not need to be withdrawn (unless the participant requests to withdraw). This is because we plan to perform an intention to treat analysis and all events after randomisation are deemed outcomes.
Q3. Are women with polyhydramnios eligible for the trial?
Women with polyhydramnios will be eligible for the trial. This is providing your hospital does not have a policy to induce women with polyhydramnios and that the clinician in charge of the woman’s care is happy for her to participate in the trial.
Q4. The fetus is breech, is the woman eligible to enter the trial?
If at the point of randomisation the fetus is breech, the woman is not eligible to enter the trial. If the women has a successful external cephalic version (ECV) prior to randomisation and the fetus is now cephalic the woman is now eligible, providing all the other eligibility criteria are met.
Q5. Are women booked for an elective caesarean section eligible to enter the cohort study?
If at the point of approaching the woman, she already has an elective caesarean section planned she is not eligible to enter the cohort study. To be eligible for the cohort study she must meet all the inclusion and exclusion criteria. If after being given the information sheet the woman opts for an elective caesarean section, she would then be considered for the cohort, providing all other criteria have been met
Q6. The fetus has an abnormality, can I recruit the woman into the trial?
If the fetus has a known serious abnormality then the woman is not eligible to be recruited. Fetuses with talipes, polydactyly and mild hydronephrosis have previously been included in the trial. If the fetus has an abnormality and you are unsure if you should recruit her then please call the trial managers who will be able to discuss this with you.
Q7. If the participant was allocated to induction, does she need to deliver by 38+4?
No. The intervention is the booking of an induction. The woman must be given a date for the induction to start between 38+0-38+4. If the woman attends in that time period, but the induction cannot be started due to capacity on labour ward, this is not a protocol deviation. It just needs to be reported on the CRF. The woman does not have to deliver in this induction window. If there is no capacity to book the induction between 38+0-38+4 please contact the trial team for further advice.
Q8. Should I send SAEs for women in the cohort study?
No. We only require you to send SAEs for women in the RCT.
Q9. What is the trial definition of a stillbirth?
A stillbirth is an intrauterine fetal death after 24 weeks gestation. Women with a previous stillbirth are not eligible to be included in the trial.
Q10. Can women enter the trial for a second time in a subsequent pregnancy?
No, women can only participate in the trial once
Q11. Can a woman be in the trial if she has had/is planning a membrane sweep?