The BEAD Feasibility Study: Baby Head Elevation device at full dilatation caesarean section

INTERVENTION: Inflation group: Fetal Pillow placed in the vagina (under the baby's head) by operating surgeon, immediately prior to caesarean section at full dilatation. Device is inflated with 180mL sterile water by the anaesthetist. Device is deflated after delivery of baby by anaesthetist. Device is removed by surgeon at end of operation. CONDITION: Caesarean section at full dilatation;Maternal uterine incision extensions; ; Caesarean section at full dilatation ; Maternal uterine incision extensions Reproductive Health and Childbirth ‐ Childbirth and postnatal care PRIMARY OUTCOME: Total number of women recruited in the second six months of the Feasibility Study. Recruitment is defined as consent, randomisation and receipt of intervention.; Assessed from data collected on the abbreviated consent form and in the electronic randomisation database.[Starting from six months after commencement of study and ending twelve months after start of recruitment] SECONDARY OUTCOME: Any extension of the maternal uterine incision. This includes any extension of the initial uterotomy. The uterotomy is the intentional, usually sharp incision into the uterus, which is followed by lateral or cephalo‐caudal blunt extension generated by traction with two fingers pulling in opposite directions. Extension of the initial uterotomy includes sharp, and inadvertent extension. In sharp extension, the uterotomy is enlarged by sharp incision into a T, a J or U ‐shape or laterally and undertaken after difficulty delivering the head is encountered. Inadvertent extension may occur laterally or inferiorly and may involve the uterine arteries, broad ligament, lower segment, cervix, vagina, bladder, or ureter. Inclusion of any of these structures (including caused by sharp incision) will be included as part of this outcome. ; Assessed by completion of the Template Tool form and review of hospital records. ; [Cumulative data will be assessed at the conclusion of the study] Birth to end of surgery (skin closure) in minutes. ; Assessed from hospital records/routinely collected data. ; [Cumulative data will be assessed at the conclusion of the study] Breastfeeding status at primary hospital discharge (fully or exclusively). Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] Composite neonatal outcome (any of perinatal death, moderate to severe HIE, seizures, significant neonatal birth injury, hypoxia at birth, NICU admission, MAS). Assessed by review of hospital records.[Cumulative data will be assessed at the conclusion of the study] Cost effectiveness of Fetal Pillow use from a hospital perspective. Assessed using hospital coding information and linkage to hospital financial records.[Cumulative data will be assessed at the conclusion of the study] Estimated blood loss (EBL) in operating theatre in mLs ; Blood loss is weighed in theatre and documented in hospital records. ; [Cumulative data will be assessed at the conclusion of the study] Incision‐to‐delivery interval in seconds. This is from time of uterotomy to time of delivery of the fetal head. ; This will be recorded on the Template tool form. ; [Cumulative data will be assessed at the conclusion of the study] Major uterine extensions – defined as into surrounding structures (uterine arteries, broad ligament, cervix, vagina, bladder, or ureter). ; This will be recorded visually and in writing on the Template tool form and hospital records will also be reviewed. ; [Cumulative data will be assessed at the conclusion of the study] Manoeuvres required for impacted fetal head and frequency of these as recorded on Template Tool form or in hospital records.[Cumulative data will be assessed at the conclusion of the study] Maternal intensive care unit (ICU) admission. Assessed by review of hospital records.[Cumulative data will be assessed at the conclusion of the study] Maternal length of stay postpartum in hours. Assessed by review of hospital records.[Cumulative data will be assessed at the conclusion of the study] Meconium aspiration syndrome (MAS). Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] Moderate to severe hypoxic ischemic encephalopathy (HIE). This is classified as Sarnat stage 2 or 3 or requiring treatment with therapeutic hypothermia (cooling). Assessed by review of hospital and neonatal unit records. ; [Cumulative data will be assessed at the conclusion of the study] Neonatal hypoxia at birth (any of cord pH <7.0, APGAR <7 at 5 mins, received cardiac massage). Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] Neonatal intensive care unit (NICU) admission of >/=4 hours. Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] Neonatal intensive care unit (NICU) length‐of‐stay in days. Assessed by review of hospital and neonatal unit records[Cumulative data will be assessed at the conclusion of the study] Neonatal seizures. Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] Perceived degree of difficulty of delivery of fetal head by the operating surgeon. Using a 4 point Likert scale, recorded on the Template Tool form.[Cumulative data will be assessed at the conclusion of the study] Perinatal death (within 28 days of delivery and during primary hospital admission). [Cumulative data will be assessed at the conclusion of the study.] Phototherapy for hyperbilirubinaemia. Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] Preterm birth (and spontaneous preterm birth) (<37 weeks) in the next pregnancy within 5 years of inde Xbirth. Measured by merge with national birthing data using coding for gestation and induction of labour and elective or emergency caesarean section. [5 years from inde Xbirth (inclusion in study).] Requirement for a maternal red blood cell (RBC) transfusion. Assessed by review of hospital records. ; [Cumulative data will be assessed at the conclusion of the study] Significant neonatal birth injury (any fracture, subgaleal haemorrhage, nerve palsy). Assessed by review of hospital and neonatal unit records.[Cumulative data will be assessed at the conclusion of the study] To assess of adequacy of clinician training for involvement in the study via face‐to‐face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team.[By si Xand twelve months after commencing recruitment.] To assess whether the quality of resources including written information and videos for clinicians are suitable. This will be assessed via face‐to‐face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team and/or study specific questionnaire.[By si Xand twelve months after start of recruitment] To assess whether the quality of resources including written information and videos for patients are suitable. This will be assessed via a study specific questionnaire.[Within seven days after caesarean section] To identify if participants consent to the collection of each of maternal, neonatal and future pregnancy data. Assessed via completion of signed consent form. ; [Within seven days after caesarean section] To identify if patients provide full consent for study participation following intrapartum consent. Assessed by completion of signed consent form.[Within seven days after caesarean section] To identify the barriers and enablers to trial participation by participant via a study specific questionnaire. ; [Within seven days after caesarean section] To identify the barriers and enablers to trial participation by research staff, medical professional and recruiting site status via face‐to‐face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team.[By si Xand twelve months after commencing recruitment.] To identify the proportion of the 'Template tool for recording uterine extensions, operating time and feedback on Fetal Pillow use' (Template tool form) that is completed. Assessed by review of study form.[By twelve months after start of recruitment.] To identify which women (by ethnicity and recruitment site) are willing to participate in a randomised trial of Fetal Pillow use at caesarean section at full dilatation. Assessed by agreement to participate (signed consent form and completion of study‐specific questionnaire) and participant demographics (via data collection forms).[Twelve months after commencing recruitment.] To undertake a qualitative analysis of/understand the intrapartum consent experiences of clinicians. This will be assessed via face‐to‐face individual or focus group interviews of up to eight clinicians facilitated by a member of the research team and/or study specific questionnaire.[By si Xand twelve months after start of recruitment] To undertake a qualitative analysis of/understand the intrapartum consent experiences of patients approached in this study. This will be assessed via a study specific questionnaire.[Within seven days after caesarean section] Total length of surgery in minutes. From initial knife‐to‐skin to final skin suture. ; Assessed from hospital records/routinely collected hospital data. ; [Cumulative data will be assessed at the conclusion of the study] INCLUSION CRITERIA: 1. Age = /> 16 years 2. Singleton pregnancy 3. Gestational age =/> 37 weeks 4. Cephalic presentation 5. Confirmed 10cm cervical dilatation