Assisted vaginal birth Pregnancy and Childbirth Other assisted single delivery
Conditions
Interventions
Chosen methodology and participant journey
The chosen methodology is an open, non-blinded single-arm single-centre feasibility study. Only one intervention arm has been included – an assisted vaginal
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women will be eligible to participate in the study if ALL of the following apply: 1. The woman is =18 years of age 2. The woman has a singleton pregnancy 3. The pregnancy is =36+0 weeks’ gestation 4. The woman may require an AVB for a clinical indication – see below Fetal Presumed fetal compromise Maternal 1. Maternal fatigue/exhaustion 2. Lack of continuing progress of the fetal head following the time limits of active second stage recommended by the National Institute of Health and Care Excellence (NICE) (2 hours for a woman in her first pregnancy with no analgesia, 1 hour for a woman in her first pregnancy with analgesia who has already been in the second stage of labour for 2 hours, 1 hour for women in a 2nd or greater pregnancy) 3. To shorten and reduce the effects of the second stage of labour on medical conditions (i.e. cardiac disease, myasthenia gravis, hypertensive crises, proliferative retinopathy, spinal cord injury patients at risk of autonomic dysreflexia, etc) *Adapted from the Royal College of Obstetricians & Gynaecologists 2011 4. The woman has effective analgesia in place during the use of the instrument (i.e. epidural, spinal or pudendal block, or perineal infiltration with local anaesthetic) 5. The practitioner providing the woman’s care in labour determines that she requires an AVB, and there is no obstetric indication for an alternative method of AVB (forceps or ventouse) Babies will be included if their mother is participating in the study
Exclusion criteria
Exclusion criteria: Women may not enter the study, or will be removed from the study, if any of the following apply: 1. The woman does not fulfil all of the inclusion criteria listed 2. There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly) 3. There is a known osteogenesis imperfecta affected pregnancy 4. There is suspicion of a fetal bleeding disorder (von Willebrand’s disease, AITP, haemophilia etc) 5. Intrauterine fetal death in the current pregnancy 6. The woman is currently serving a prison sentence 7. The woman lacks capacity to consent 8. The woman has a lack of ability to read or understand English as this would preclude successful completion of questionnaires 9. Latex sensitivity 10. Fetal bradycardia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful vaginal birth with BD Odon Device; Timepoint(s): At birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcomes: 1. Failure to achieve a vaginal birth with the assistance of a BD Odon Device, measured at birth 2. Use of emergency Caesarean section to achieve birth, measured at birth 3. Postpartum haemorrhage >3,000ml, measured within 24 hours of birth 4. 3rd or 4th degree anal sphincter tear, measured at birth 5. Cervical tear, measured at birth 6. Maternal death up to 90 days post birth 7. Maternal health-related quality of life (EQ-5D-5L) antenatally, at day one and day 28 postnatal 8. Maternal pain: use of analgesia measured at day 1 and day 7 postnatal, maternal reported pain measured on 11-point Likert scale at day 1, day 7, day 28 and day 90 postpartum 9. Maternal continence, measured with the Aberdeen Postnatal Incontinence Questionnaire at 90 days postpartum 10. Maternal satisfaction with birth experience, measured with the Patient Perception Score on day 1 postnatal Neonatal outcome measures: 1. Apgar score <7 at 5 minutes 2. Neonatal pain, measured by Neonatal Infant Pain Score at 2 and 6 hours after birth 3. Shoulder dystocia, measured at birth 4. Admission to Neonatal Intensive Care Unit within 28 days after birth 5. Phototherapy for bruising, measured within 7 days of birth 6. Pressure necrosis of fat or skin, measured within 28 days of birth 7. Other neonatal injury within 28 days of birth 8. Neonatal death within 28 days of birth 9. Failure to establish normal feeding pattern (defined as =1 feed at 10 hours of age) 10. Method of feeding on day 1, day 7, day 28 and day 90 postpartum 1. Failure of a component of the BD Odon Device before or during delivery 2. Practitioner reported perception of BD Odon Device (willingness to use device, overall ease of use, ease of device setup, ease of application, ease of withdrawal, comfort, ease of deflation – all measured on five-point Likert scale) measured within 24 hours of birth 3. Patient recruitment, participation and follow-up rates and reasons for declining or withdrawal (medical, personal, log | — |
Countries
England, United Kingdom
Outcome results
None listed