Reduced Fetal Movement Intervention Trial (ReMIT-2)

ReMIT2 is a pilot feasibility trial and therefore does not have primary and secondary outcomes like a standard drug trial. There are feasibility outcomes which determine the feasibility of doing a large main trial based on results collected in ReMIT2 and there are proof of concept outcomes which address whether the intervention might have an effect on neonatal outcome or healthcare costs.

Current feasibility outcomes as of 23/04/2018:
1. Number of potentially eligible women at each site and number of women recruited at each site as collected from hospital records at the time women attend with RFM throughout recruitment period.
2. Proportion lost to follow-up after discharge from hospital and reasons for loss to follow-up as collected from hospital records at the time site confirms participant is lost to follow-up.
3. Spectrum of clinical characteristics of women at randomisation (frequency of small for gestational age (SGA) fetuses, obstetric history, nulliparous) as collected from patient medical records at randomisation.
4. Reasons for non-recruitment, if available as collected from hospital records of women who attend with RFM throughout recruitment period:
4.1. Views of women about reasons for not participating collected at point trial is offered using an Anonymous Survey
4.2. CI site only: Women will be offered short interview within 1 week of presenting with RFM to gain further insight into their reasons for not participating in the trial using a semi-structured interview guide
5. Compliance with the trial interventions and reasons for non-compliance as collected from patient medical records at the time the trial intervention is delivered.
6. Completeness of data collection for planned outcomes in the main trial including that needed for health economic analyses as measured using the SF12 questionnaires at baseline and ~6 weeks after birth, plus a Health Resource Questionnaire at ~ 6 weeks after birth.
7. CI site only: participants’ views on sFlt-1/PlGF test collected at point results are given using scripted Test Performance questions.
8. Views of women about participation collected ~6 weeks after birth using a Participant Views questionnaire.
8.1. A sub-group of participants will be interviewed ~16 weeks after birth to gain further insight into their views of the trial using a semi-structured interview guide.
9. Views of clinicians on sFlt-1/PlGF test performance collected prior to recruiting first participant using a Health Professional Views questionnaire.
10. Views of clinicians on the trial collected prior to closing recruitment using a Health Professional Views questionnaire.

Previous feasibility outcomes:
1. Number of potentially eligible women at each site and number of women recruited at each site as collected from hospital records at the time women attend with RFM throughout recruitment period.
2. Proportion lost to follow-up after discharge from hospital and reasons for loss to follow-up as collected from hospital records at the time site confirms participant is lost to follow-up.
3. Spectrum of clinical characteristics of women at randomisation (frequency of small for gestational age (SGA) fetuses, obstetric history, nulliparous) as collected from patient medical records at randomisation.
4. Reasons for non-recruitment, if available as collected from hospital records of women who attend with RFM throughout recruitment period.
5. Compliance with the trial interventions and reasons for non-compliance as collected from patient medical records at the time the trial intervention is delivered.
6. Completeness of data collection for planned outcomes in the main trial including that needed for health economic analyses as measured using the SF12 questionnaires at baseline and ~6 weeks after birth, plus a Health Resource Questionnaire at ~ 6 weeks after birth.
7. Views of women about participation collected ~6 weeks after birth using a Participant Views questionnaire.
7.1. A sub-group of participants will be interviewed ~16 weeks after birth to gain further insight into their views of the trial using a semi-structured interview guide.
8. Views of clinicians on the trial collected 9-12 months after site initiation using a Health Professional Views questionnaire.

Proof of concept outcomes:
1. Frequency of induction of labour or planned caesarean and reasons for these procedures as collected from patient medical records at the time of the baby’s birth
2. Neonatal outcome including:
2.1. Stillbirths and deaths before discharge as collected from patient medical records at the time of the baby’s birth
2.2. Five minute Apgar score of <7 as collected from patient medical records at the time of the baby’s birth
2.3. Umbilical artery pH <7.05 as collected from patient medical records at the time of the baby’s birth
2.4. Admission to the neonatal unit for >48 hours as collected from patient medical records at the time the baby is discharged from the neonatal unit
2.5. SGA (<10th centile on neonatal birthweight standards) as collected from patient medical records at the time of the baby’s birth
2.6. Use of therapeutic cooling as collected from patient medical records during the time the baby is on the neonatal unit
2.7. Length of stay in hospital. Collected from patient medical records at the time of the baby’s discharge from hospital
2.8. Duration of respiratory support as collected from patient medical records during the time the baby is on the neonatal unit
2.9. Number of dependency days on neonatal unit as collected from patient medical records during the time the baby is on the neonatal unit
3. Maternal hypertensive disorders defined as development of gestational hypertension or pre-eclampsia as collected from patient medical records prior to baby’s birth
4. Maternal deaths prior to discharge as collected from patient medical records prior to discharge from hospital
5. Maternal admissions to Intensive Care Unit (ICU) as collected from patient medical records prior to discharge from hospital
6. Change in Generalised Anxiety Disorder 2 (GAD-2) scale measured at enrolment and ~6 weeks after birth
7. Quantifiable impact on costs and outcomes incurred by delivering the intervention from an NHS perspective and as assessed by the SF-12™ Health Survey measured at enrolment and ~6 weeks after birth along with a Health Resource Use questionnaire measured ~6 weeks after birth
8. The diagnostic performance of the placental factor test in participants allocated to the control arm of the trial as measured by central laboratory analysis using a Roche Cobas plus sFlt-1 and PlGF kits