Women's perspectives on caesarean section recovery, infection and the PREPS trial: a qualitative pilot study.

BACKGROUND: In England, 27.8% of all pregnant women undergo caesarean sections (CS) to deliver their babies. Women undergoing CS are at risk of developing sepsis and post-natal infections, which not only contribute significantly to maternal mortality and morbidity, but also negatively impact upon post-natal recovery and wellbeing. This study explores patients' priorities in relation to CS recovery, focusing on their knowledge and experiences of infection prevention. The study formed part of the PREPS (Vaginal Preparation at caesarean section to Reduce Endometritis and Prevent Sepsis - a feasibility study of chlorhexidine) Trial; patients' views on the PREPS Trial were also sought. METHODS: Using qualitative methodology, two focus groups and six telephone interviews were carried out between September and October 2017 with a total of 21 women who had undergone a CS within the preceding six months. Focus groups and individual telephone interviews were audio-recorded and transcribed verbatim; a thematic analysis was conducted using NVivo 11. RESULTS: Women's priorities around CS recovery centred on pain (or the lack thereof), mobility and the ability to resume everyday activities, including caregiving. Those undergoing a CS for the first time reported not feeling confident in their ability to identify signs of infection and sought visiting health professionals' expertise and reassurance. Women were unable to recall whether they had received information regarding infection prevention and felt that they had not received sufficient advice. Some reported receiving general information regarding CS recovery, which ranged in quality. Prevention of womb infection is a major goal of the PREPS trial, however, the majority of women were not aware that womb (as opposed to wound) infection was a post CS risk. CONCLUSIONS: Women undergoing a CS want more information on what constitutes a 'normal' post-operative recovery and specifically would welcome written information and infection prevention advice. This should be a key element of improving post-CS maternal experiences and potentially reducing sepsis and infection rates. CS stigma negatively impacts women's recovery experiences and possibly information provision. The PREPS team incorporated findings regarding consent pathways for recruiting women into intrapartum research and developed two patient reported outcomes to collect in the main trial. TRIAL REGISTRATION: The PREPS trial has been registered with ISRCTN on the 10th July 2017 ( ISRCTN33435996 ).

C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes-a multicentre randomised controlled trial.

BACKGROUND: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior. METHODS: A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials. DISCUSSION: Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates. TRIAL REGISTRATION: ISRCTN 15373349 . Registered before recruitment on 03 December 2014 prior to first recruit.

Preterm labour decision-making and experiences of care for women and clinicians (QUIDS Qualitative): A qualitative exploration.

BACKGROUND: Minimising the risks of mortality, morbidities, and the costs associated with preterm birth is reliant on accurate prediction, appropriate decision-making and timely intervention. This study aimed to determine for the first time the decisional and informational requirements of women and clinicians during preterm labour diagnosis and intervention. A secondary objective was to explore their experiences. STUDY DESIGN: A qualitative, interpretive approach was used in three tertiary referral units in England and Scotland. Women with experience of or risk factors for preterm birth and clinicians with experience of caring for women in preterm labour took part in semi-structured interviews individually face-face or via telephone, or in a small focus-group. Data was analysed using a framework approach. RESULTS: Women and clinicians welcomed a more accurate tool for predicting preterm birth. Women wanted to be actively involved in their care, but desired different levels of control over decisions. Communication between women and clinicians influenced women's overall experiences and shaped clinicians' practice. Women found accessing care difficult, due to uncertainty about symptoms and gatekeepers to face-face care. The emotional impact of their experiences influenced family plans and subsequent pregnancies. Women's overall perception of their experience was influenced by their judgement of the care they received. CONCLUSIONS: Decision-making is complex and a tool to more accurately predict preterm birth than is currently available was valued. Further research is warranted to evaluate a tool in clinical practice and to improve services for women with symptoms of preterm labour attempting to gain access to face-face care. Trial Registration ISRCTN: 41598423 and CPMS:31277.