A Pregnancy and Postnatal RCT Among Women With Gestational Diabetes Mellitus and Overweight/Obesity: The PAIGE2 Study.

Objective: This study examined the influence of a pregnancy and postnatal multicomponent lifestyle intervention for women with gestational diabetes mellitus (GDM) and overweight/obesity from 6 weeks to 12 months postnatal. The primary outcome was weight at 12 months. Secondary outcomes included change in body mass index (BMI), waist circumference (WC) and fasting plasma glucose (FPG). Methods: The study involved 235 pregnant women with GDM and BMI ≥ 25 kg/m2 during pregnancy. Intervention components included an educational session, activity tracker (Fitbit), monthly phone calls, weekly motivational text messages, 12-week voucher for a commercial weight management organization and anthropometric, biochemical, and clinical measurements taken at 6 weeks, 6 months, and 12 months postnatal. The control group received routine local maternity care. Results: A mean weight change of -2.0 (SD 7.1) kg was observed in the intervention group compared with -0.6 (SD 8.0) kg in the control group, difference -1.4 (95% CI -4.4, 1.5) kg from 6 weeks to 12 months postnatal, but this was not statistically significant (P = .34). Neither were significant differences obtained for any secondary outcomes: BMI -0.6 (-1.6, 0.5) kg/m2, WC -1.0 (-5.1, 3.2) cm and FPG 0.07 (-0.15, 0.29) mmol/L. Conclusion: This lifestyle intervention among women with overweight/obesity and GDM resulted in a statistically nonsignificant 1.4 kg greater weight loss compared with routine care at 12 months postnatal. Further research is needed to understand how the different components of this lifestyle intervention might be better applied to elicit more successful results.

Women's experiences of outpatient induction of labour with double balloon catheter or prostaglandin pessary: A qualitative study.

BACKGROUND: One quarter to one third of women experience induction of labour. Outpatient induction of labour may be safe and effective but women's views of this setting and of different methods of induction are sparse. AIM: To explore women's experiences of outpatient induction of labour with either prostaglandin pessary or double balloon catheter. METHODS: Qualitative study using semi-structured, audio-recorded interviews with twenty-one women recruited to a feasibility trial of outpatient induction of labour. Transcripts were coded and analysed using a thematic framework approach. FINDINGS: Two key themes were identified. 'Ownership of induction of labour' concerned how women understood and experienced the induction of labour process and tried to maintain control of a procedure managed by medical professionals. Women felt unprepared for the steps in the process and for the time it would take. The balloon method was preferred as it was considered a gentler start to the process, although some women reported it was painful on insertion. 'Importance of place' reflected women's associations of the home with comfort, ease of support and distraction, and the hospital with safety yet also with discomfort and delays. DISCUSSION: This sample of women were keen to start induction without hormones. The randomised controlled trial design may have biased the sample towards women who wanted to experience the balloon method and outpatient setting where these were not usually offered, thus further cohort studies would be beneficial. CONCLUSIONS: Women were positive about experiencing the early stages of induction of labour at home with the balloon catheter.

Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F).

BACKGROUND: The aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting. METHODS: An open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥ 16 years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire. RESULTS: During the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess (n = 20) and CRB (n = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for inpatient IOL (n = 22) and preference for a specific method, Propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. - 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. CONCLUSIONS: A third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers. TRIAL REGISTRATION: NCT03199820. Registered on June 27, 2017.

Women's experiences of induction of labour: Qualitative systematic review and thematic synthesis.

OBJECTIVES: To explore and synthesise evidence of women's experiences of induction of labour (IoL). DESIGN: Systematic review and thematic synthesis of peer-reviewed qualitative evidence. Relevant databases were searched from inception to the present day. Study quality was appraised using the Critical Appraisal Skills Programme (CASP) qualitative research appraisal tool. SETTING AND PARTICIPANTS: Low and high risk women who had experienced IoL in an inpatient or outpatient setting. FINDINGS: Eleven papers (representing 10 original studies) published between 2010 and 2018 were included for thematic synthesis. Four key analytical themes were identified: ways in which decisions regarding induction were made; women's ownership of the process; women's social needs when undergoing IoL; and the importance of place in the induction process. The review indicates that IoL is a challenging experience for women, which can be understood in terms of the gap between women's needs and the reality of their experience concerning information and decision-making, support, and environment. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Providing good quality appropriately timed information and supporting women's self-efficacy to be involved in decision-making around IoL may benefit women by facilitating a sense of ownership or control of labour. Compassionate support from significant others and healthcare professionals in a comfortable, private and safe environment should be available to all women.