Assisted vaginal birth Pregnancy and Childbirth Assisted vaginal birth
Conditions
Interventions
Participants (women who require an assisted vaginal birth for a known clinical indication) will have their baby’s birth assisted with BD Odon Device (rather than forceps or ventouse – which would be u
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 and over 2. In the final stage of labour (full cervical dilatation) who require an AVB. This could be because their labour has slowed down, there are concerns about their baby’s heart rate, or there is a medical reason to shorten the amount of time a woman should push for during labour 3. Informed consent has previously been given and has been reconfirmed. All ‘consent’ inclusion have been re-assessed and remain valid. 4. Pregnancy is =36+0 weeks’ gestation. 5. The woman is in labour and requires an assisted vaginal birth for a clinical indication (as per the Royal College of Obstetricians & Gynaecologists Greentop Guideline, 2011). The RCOG specific requirements for AVB are fulfilled (as per the Royal College of Obstetricians & Gynaecologists Greentop Guideline, 2011). The vertex is 1cm or more below ischial spines. 6. 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). 7. 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 metal cup). Availability of a suitably trained practitioner.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 10/03/2021: 1. The woman does not fulfil all of the inclusion criteria listed 2. Maternal-reported fetal skull abnormality, fetal osteogenesis imperfecta or fetal bleeding disorder 3. Intrauterine fetal death in the current pregnancy 4. The woman is currently serving a prison sentence 5. The woman lacks the capacity to consent 6. The woman has a lack of ability to read or understand English 7. Sensitivity to latex 8. Informed consent is withdrawn 9. There is an ongoing fetal bradycardia 10. Current confirmed or clinically suspected Covid-19 infection 11. Woman is shielding from Covid-19 due to a medical condition or medication as per current PHE guidance 12. No Odon trained practitioner available to assist the birth _____ Previous exclusion criteria: 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. The indication for AVB is a fetal bradycardia which is present and on-going and has not recovered 11. Informed consent is withdrawn at anytime 12. Any of the ‘consent’ or ‘participation’ inclusion criteria are not met 13. No Odon trained practitioner available to assist the birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Rate of births successfully assisted with the BD Odon Device A birth will be defined as ‘successful’ if all of the following criteria are met: 1. The birth of the baby is expedited with the Odon Device 2. There are no serious maternal adverse reactions related to the use of the device during birth 3. There are no serious neonatal adverse reactions related to the use of the device during birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are categorised below and include measures needed to test the feasibility of a RCT: 1. Birth 1.1 Time from “decision to perform assisted birth” to “birth” (minutes) 1.2 Time from “device application” to “birth” (minutes) 1.3 Time between “decision to perform assisted birth” to “time of Odon application” 1.4 Location of birth 1.5 Mode of birth following failed use of Odon device 2. Device 2.1 Failure of a component of the Odon device 2.2 Number of applications of device 2.3 Number of pulls of the device 2.4 Any trauma caused by first device application 2.5 Perceived reason for device failure from operator (maternal/clinical/device/other) 3. Maternal 3.1 Weighed estimated blood loss 3.2 Perineal and anal sphincter injury (1st/2nd/3rd/4th degree tears and episiotomy) 3.3 Ischio-rectal fossa defect 3.4 Cervical tear (present not requiring suturing) 3.5 Cervical tear (present requiring suturing) 3.6 Labial tear requiring suturing 3.7 Lower segment Caesarean section performed (Yes/No) 3.8 Use of analgesia days 1, 7 and 28 post natal 3.9 Details of analgesia used at days 1, 7 and 28 post natal 3.10 Maternal death 3.11 Length of hospital stay following birth 4. Neonatal 4.1 Umbilical artery pH and base excess 4.2 Umbilical vein pH and base excess 4.3 Shoulder dystocia 4.4 Apgar scores at 1, 5 and 10 minutes post natal 4.5 Neonatal Infant Pain Scores at 2 and 6 hours post natal 4.6 Neonatal feed by 10 hours post natal 4.7 Method of feeding days 1, 7, 28 and 90 post natal 4.8 Admission to Neonatal Intensive Care Unit (NICU) 4.9 Time spent in NICU (hours) 4.10 Neonatal soft tissue trauma (bruise/scalp/facial injury/cephalohaematoma) 4.11 Neonatal vascular injury (subaponeurotic haemorrhage) 4.12 Neonatal body maps (head and neck) 4.13 Neonatal skeletal injury (bone fracture) 4.14 Neonatal intra-cranial injury (cerebral contusion) 4.15 Neonatal neurological injury still present at day 28 post natal 4.16 Neonatal seizure by day 28 post natal 4.17 P | — |
Countries
England, United Kingdom
Outcome results
None listed