The BD Odon Device™ for assisted vaginal birth

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 126

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

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 Informed consent is withdrawn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

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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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Rate of births successfully assisted with the BD Odon Device<br>A birth will be defined as ‘successful’ if all of the following criteria are met: <br>1. The birth of the baby is expedited with the Odon Device<br>2. There are no serious maternal adverse reactions related to the use of the device during birth<br>3. There are no serious neonatal adverse reactions related to the use of the device during birth

Secondary Outcome Measures

Name	Time	Method

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