Reduced Fetal Movement Intervention Trial (ReMIT-2)

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: Maternal/ Fetal medicine

Armstrong-Buisseret L, Godolphin PJ, Bradshaw L, Mitchell E, Ratcliffe S, Storey C, Heazell AEP.

2020-02-136 citations

Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36<sup>+ 0</sup> weeks gestation.

Armstrong-Buisseret L, Mitchell E, Hepburn T, Duley L, Thornton JG, Roberts TE, Storey C, Smyth R, Heazell AEP.

2018-10-017 citations

10.1186/s13063-018-2859-1

Interventions

Eligible participants are randomised in a 1:1 ratio to either the intervention arm or the control arm. Randomisation is stratified by site and number of weeks gestation when the participant first pres

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women presenting with RFM before the onset of labour between 36+0 and 41+0 weeks gestation (assessment of gestation will be based on the best available information which will usually be the first or dating scan) 2. Viable singleton pregnancy on initial assessment 3. No indication for immediate delivery as assessed by CTG and ultrasound scan 4. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Maternal age 50 years 2. Fetus known to have any of the following congenital anomalies as per the Fetal Anomalies Screening Programme (FASP): 2.1. Anencephaly 2.2. Open spina bifida 2.3. Cleft lip 2.4. Diaphragmatic hernia 2.5. Gastrochisis 2.6. Exomphalos 2.7. Serious cardiac abnormalities 2.8. Bilateral renal agenesis 2.9. Lethal skeletal dysplasia 2.10. Edward’s syndrome (trisomy 18) 2.11. Patau’s syndrome (trisomy 13) 2.12. Any other severe structural abnormality 3. Multiple pregnancy 4. Women for whom it is their first attendance to ANY antenatal care e.g. “unbooked” women 5. Previous randomisation into the ReMIT-2 trial in this pregnancy 6. Concurrent participation in the intervention phase of another clinical trial which determined the timing or mode of delivery

Design outcomes

Primary

Measure	Time frame
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 an	—

Measure

Time frame

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 an

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Secondary

Measure	Time frame
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 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-1	—

Measure

Time frame

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 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-1

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Countries

United Kingdom

Contacts

Public ContactLindsay Armstrong-Buisseret

remit2@nottingham.ac.uk-

Outcome results

None listed