The BD Odon Device for assisted vaginal birth

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 97

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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