OBJECTIVES: To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA).
SEARCH STRATEGY: We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour.
SELECTION CRITERIA: We selected trials including pregnant women between 24 and 36(6/7) weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment.
DATA COLLECTION AND ANALYSIS: The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed.
MAIN RESULTS: Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95% confidence interval, 95% CI 0.35-5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95% CI 0.16-2.67), necrotising enterocolitis (NEC) (RR 1.15; 95% CI 0.50-2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95% CI 0.51-1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95% CI 0.55-1.01).
CONCLUSION: Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice.
TWEETABLE ABSTRACT: Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.
DESIGN: A prospective study.
SETTING: A tertiary hospital in Malaysia.
POPULATION: A cohort of 193 term nulliparous women with intact membranes.
METHODS: Prior to labour induction, cervical fluid was obtained via a vaginal speculum and tested for IGFBP-1, followed by TVUS and finally Bishop score. After each assessment the procedure-related pain was scored from 0 to 10. Cut-off values for Bishop score and cervical length were obtained from the receiver operating characteristic (ROC) curve. Multivariable logistic regression analysis was performed.
MAIN OUTCOMES MEASURES: Vaginal delivery and vaginal delivery within 24 hours of starting induction.
RESULTS: Bedside IGFBP-1 testing is better tolerated than Bishop score, but is less well tolerated than TVUS [median (interquartile range) of pain scores: 5 (4-5) versus 6 (5-7) versus 3 (2-3), respectively; P < 0.001]. IGFBP-1 independently predicted vaginal delivery (adjusted odds ratio, AOR 5.5; 95% confidence interval, 95% CI 2.3-12.9) and vaginal delivery within 24 hours of induction (AOR 4.9; 95% CI 2.1-11.6) after controlling for Bishop score (≥4 or ≥5), cervical length (≤29 or ≤27 mm), and other significant characteristics for which the Bishop score and TVUS were not predictive of vaginal delivery after adjustment. IGFBP-1 has 81% sensitivity, 59% specificity, positive and negative predictive values of 82 and 58%, respectively, and positive and negative likelihood ratios of 2.0 and 0.3 for vaginal delivery, respectively.
CONCLUSION: IGFBP-1 better predicted vaginal delivery than BS or TVUS, and may help guide decision making regarding labour induction in nulliparous women.
TWEETABLE ABSTRACT: IGFBP-1: a stronger independent predictor of labour induction success than Bishop score or cervical sonography.
DESIGN: Retrospective observational study.
POPULATION: A total of 1258 consecutive women attending a tertiary urogynaecological unit for the investigation of lower urinary tract or pelvic floor disorders between January 2012 and December 2014.
METHODS: Obstetric history and clinical examination data were obtained from the unit database. Prolapse quantification on imaging was performed using stored four-dimensional translabial ultrasound volume data sets. Women were grouped into four groups according to the most traumatic delivery reported. The presence of symptoms and signs of POP were compared between delivery groups while controlling for potential confounders.
MAIN OUTCOME MEASURES: Prolapse symptoms, visual analogue score for prolapse bother, International Continence Society Prolapse Quantification System findings and ultrasound findings of anterior, central and posterior compartment descent.
RESULTS: Nulliparae showed the lowest prevalence of most measures of POP, followed by women exclusively delivered by caesarean section. Highest prevalences were consistently found in women delivered at least once by forceps, although the differences between this group and women delivered by normal vaginal delivery and/or vacuum extraction were significant in three out of eight measures only. Compared with women in the caesarean section group, the adjusted odds ratios for reporting symptoms of prolapse were 2.4 (95% CI 1.30-4.59) and 3.2 (95% CI 1.65-6.12) in the normal vaginal delivery/vacuum extraction group and forceps group, respectively.
CONCLUSIONS: There is a clear link between vaginal delivery and symptoms and signs of pelvic organ prolapse in urogynaecological patients.
TWEETABLE ABSTRACT: Compared with caesarean section a history of vaginal delivery more than doubles the risk for POP.
SETTING: Obstetric unit of a university hospital in Kuala Lumpur, Malaysia.
POPULATION: Women admitted for a planned caesarean under spinal anaesthesia.
METHODS: Participants were randomised to a sandwich meal served immediately on return to the ward or on-demand.
MAIN OUTCOME MEASURES: Primary outcomes were patient satisfaction VAS (visual analog scale of 100 mm) on the feeding regimen and vomiting at 24 hours.
RESULTS: 453 women were initially enrolled, 395 were randomised and available for analysis. Median (full range) patient satisfaction VAS scores were 82 (15-100) versus 84 (0-100) mm, P = 0.88 and vomiting rates were 1/197 (0.5%) versus 2/198 (1.0%), P > 0.99 for immediate compared with on-demand feeding, respectively. The immediate versus on-demand arms first ate at a median of 105 (35-210) versus 165 (45-385) minutes, P
DESIGN: Randomised trial.
SETTING: University Hospital, Malaysia: April 2016-October 2016.
POPULATION: 331 women delivered by caesarean section.
METHOD: Participants were randomised to leaving their wound entirely exposed (n = 165) or dressed (n = 166) with a low adhesive dressing (next day removal).
MAIN OUTCOME MEASURES: Primary outcomes were superficial SSI rate (assessed by provider inspection up to hospital discharge and telephone questionnaires on days 14 and 28) and patient satisfaction with wound coverage management before hospital discharge.
RESULTS: The superficial SSI rates were 2/153 (1.3%) versus 5/157 (3.2%) (relative risk [RR] 0.4, 95% CI 0.1-2.1; P = 0.45) and patient satisfaction with wound management was 7 [5-8] versus 7 [5-8] (P = 0.81) in exposed compared with dressed study groups, respectively. In the wound-exposed patients, stated preference for wound exposure significantly increased from 35.5 to 57.5%, whereas in the wound-dressed patients, the stated preference for a dressed wound fell from 48.5 to 34.4% when assessed at recruitment (pre-randomisation) to day 28. There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to day 28 across trial groups.
CONCLUSION: The trial is underpowered as SSI rates were lower than expected. Nevertheless, leaving caesarean wounds exposed does not appear to have detrimental effects, provided patient counselling to manage expectations is undertaken.
TWEETABLE ABSTRACT: An exposed compared with a dressed caesarean wound has a similar superficial surgical site infection rate, patient satisfaction and appearance.
DESIGN: Randomised trial.
SETTING: University Hospital, Malaysia: April 2016-April 2017.
POPULATION: One hundred and sixty women hospitalised for HG.
METHOD: Women were randomised upon admission to fasting for 12 hours or expedited oral feeding. Standard HG care was instituted.
MAIN OUTCOME MEASURE: Primary outcome was satisfaction score with overall treatment at 24 hours (0-10 Visual Numerical Rating Scale VNRS), vomiting episodes within 24 hours and nausea VNRS score at enrolment, and at 8, 16 and 24 hours.
RESULTS: Satisfaction score, median (interquartile range) 8 (5-9) versus 8 (7-9) (P = 0.08) and 24-hour vomiting episodes were 1 (0-4) versus 1 (0-5) (P = 0.24) for 12-hour fasting versus expedited feeding, respectively. Repeated measures analysis of variance of nausea scores over 24 hours showed no difference (P = 0.11) between trial arms. Participants randomised to 12-hour fasting compared with expedited feeding were less likely to prefer their feeding regimen in future hospitalisation (41% versus 65%, P = 0.001), to recommend to a friend (65% versus 84%, P = 0.01; RR 0.8, 95% CI 0.6-0.9) and to adhere to protocol (85% versus 95%, P = 0.04; RR 0.9, 95% CI 0.8-1.0). Symptoms profile, ketonuria status at 24 hours and length of hospital stay were not different.
CONCLUSION: Advisory of 12-hour fasting compared with immediate oral feeding resulted in a non-significant difference in satisfaction score but adherence to protocol and fidelity to and recommendation of immediate oral feeding to a friend were lower. The 24-hour nausea scores and vomiting episodes were similar.
TWEETABLE ABSTRACT: Women hospitalised for hyperemesis gravidarum could feed as soon, as much and as often as can be tolerated compared with initial fasting.
DESIGN: Prospective observational cohort study.
SETTING: Single tertiary multidisciplinary antenatal clinic in Malaysia.
POPULATION: A total of 507 mothers: 145 with gestational diabetes mellitus (GDM); 94 who were obese with normal glucose tolerance (NGT) (pre-gravid body mass index, BMI ≥ 27.5 kg/m2 ), and 268 who were not obese with NGT.
METHODS: Maternal demographic, anthropometric, and clinical data were collected during an interview/examination using a structured questionnaire. Blood was drawn for insulin, C-peptide, triglyceride (Tg), and non-esterified fatty acid (NEFA) during the 75-g 2-hour oral glucose tolerance test (OGTT) screening, and again at 36 weeks of gestation. At birth, neonatal anthropometrics were assessed and data such as gestational weight gain (GWG) were extracted from the records.
MAIN OUTCOME MEASURES: Macrosomia, large-for-gestational-age (LGA) status, cohort-specific birthweight (BW), neonatal fat mass (NFM), and sum of skinfold thickness (SSFT) > 90th centile.
RESULTS: Fasting Tg > 95th centile (3.6 mmol/L) at screening for OGTT was independently associated with LGA (adjusted odds ratio, aOR 10.82, 95% CI 1.26-93.37) after adjustment for maternal glucose, pre-gravid BMI, and insulin sensitivity. Fasting glucose was independently associated with a birthweight ratio (BWR) of >90th centile (aOR 2.06, 95% CI 1.17-3.64), but not with LGA status, in this well-treated GDM cohort with pre-delivery HbA1c of 5.27%. In all, 45% of mothers had a pre-gravid BMI of <23 kg/m2 and 61% had a pre-gravid BMI of ≤ 25 kg/m2 , yet a GWG of >10 kg was associated with a 4.25-fold risk (95% CI 1.71-10.53) of BWR > 90th centile.
CONCLUSION: Maternal lipaemia and GWG at a low threshold (>10 kg) adversely impact neonatal adiposity in Asian offspring, independent of glucose, insulin resistance and pre-gravid BMI. These may therefore be important modifiable metabolic targets in pregnancy.
TWEETABLE ABSTRACT: Maternal lipids are associated with adiposity in Asian babies independently of pre-gravid BMI, GDM status, and insulin resistance.
DESIGN: Population-based multi-country analyses.
SETTING: Births collected through routine data systems in 13 countries.
SAMPLE: 125 419 255 total births from 22+0 to 44+6 weeks' gestation identified from 2000 to 2020.
METHODS: We included 635 107 stillbirths from 22+0 weeks' gestation from 13 countries. We classified all births, including stillbirths, into six 'newborn types' based on gestational age information (preterm, PT, <37+0 weeks versus term, T, ≥37+0 weeks) and size-for-gestational age defined as small (SGA, <10th centile), appropriate (AGA, 10th-90th centiles) or large (LGA, >90th centile) for gestational age, according to the international newborn size for gestational age and sex INTERGROWTH-21st standards.
MAIN OUTCOME MEASURES: Distribution of stillbirths, stillbirth rates and rate ratios according to six newborn types.
RESULTS: 635 107 (0.5%) of the 125 419 255 total births resulted in stillbirth after 22+0 weeks. Most stillbirths (74.3%) were preterm. Around 21.2% were SGA types (PT + SGA [16.2%], PT + AGA [48.3%], T + SGA [5.0%]) and 14.1% were LGA types (PT + LGA [9.9%], T + LGA [4.2%]). The median rate ratio (RR) for stillbirth was highest in PT + SGA babies (RR 81.1, interquartile range [IQR], 68.8-118.8) followed by PT + AGA (RR 25.0, IQR, 20.0-34.3), PT + LGA (RR 25.9, IQR, 13.8-28.7) and T + SGA (RR 5.6, IQR, 5.1-6.0) compared with T + AGA. Stillbirth rate ratios were similar for T + LGA versus T + AGA (RR 0.7, IQR, 0.7-1.1). At the population level, 25% of stillbirths were attributable to small-for-gestational-age.
CONCLUSIONS: In these high-quality data from high/middle income countries, almost three-quarters of stillbirths were born preterm and a fifth small-for-gestational age, with the highest stillbirth rates associated with the coexistence of preterm and SGA. Further analyses are needed to better understand patterns of gestation-specific risk in these populations, as well as patterns in lower-income contexts, especially those with higher rates of intrapartum stillbirth and SGA.