Search

Background: Women's views are critical for informing the planning and delivery of maternity care services. ST segment analysis (STan) is a promising method to more accurately detect when unborn babies are at risk of brain damage or death during labour that is being trialled for the first time in Australia. This is the first study to examine women's views about STan monitoring in this context., Methods: Semi-structured interviews were conducted with pregnant women recruited across a range of clinical locations at the study hospital. The interviews included hypothetical scenarios to assess women's prospective views about STan monitoring (as an adjunct to cardiotocography, (CTG)) compared to the existing fetal monitoring method of CTG alone. This article describes findings from an inductive and descriptive thematic analysis., Results: Most women preferred the existing fetal monitoring method compared to STan monitoring; women's decision-making was multifaceted. Analysis yielded four themes relating to women's views towards fetal monitoring in labour: a) risk and labour b) mobility in labour c) autonomy and choice in labour d) trust in maternity care providers., Conclusions: Findings suggest that women's views towards CTG and STan monitoring are multifaceted, and appear to be influenced by individual labour preferences and the information being received and understood. This underlies the importance of clear communication between maternity care providers and women about technology use in intrapartum care. This research is now being used to inform the implementation of the first properly powered Australian randomised trial comparing STan and CTG monitoring.

Background: Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate., Methods/design: Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity. Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410)., Discussion: This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies., Trial Registration: This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.

Background: Occiput posterior position is the most common malpresentation in labour, contributes to about 18% of emergency caesarean sections and is associated with a high risk of assisted delivery. Caesarean section is now a major contributing factor to maternal mortality and morbidity following childbirth in developed countries. Obstetric intervention by forceps and ventouse delivery is associated with complications to the maternal genital tract and to the neonate, respectively. There is level 2 evidence that prophylactic manual rotation reduces the caesarean section rate and assisted vaginal delivery. But there has been no adequately powered randomised controlled trial. This is a protocol for a double-blinded, multicentre, randomised controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate., Methods/design: Eligible participants will be (greater than or equal to) 37 weeks' with a singleton pregnancy and a cephalic presentation in the occiput posterior position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 68%, then for a reduction to 50%, an alpha value of 0.05 and a beta value of 0.2, 254 participants will need to be enrolled. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, and protocol number X110410. Participants with written consent will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery (defined as vacuum, forceps and/or caesarean section deliveries). Secondary outcomes will be caesarean section, significant maternal mortality/morbidity and significant perinatal mortality/morbidity. Analysis will be by intention-to-treat. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. The results of the trial will be presented at one or more medical conferences. The trial will be submitted to peer review journals for consideration for publication. There will be potential to incorporate the results into professional guidelines for obstetricians and midwives., Trial Registration: The Australian New Zealand Clinical Trials Registry ACTRN12612001312831 . Trial registered 12 December 2012.