Pooja Maharjan

and 5 more

Background There is evidence to suggest that many medicines commonly used for pregnant women for the management of hypertensive disorders of pregnancy are poor quality. Objective To review the available studies systematically reporting medicine quality, routinely used in the prevention and management of hypertensive disorders of pregnancy. Search strategy We searched five electronic databases- Ovid MEDLINE, EMBASE, CINAHL, ProQuest and Cochrane Library, without year or language limitations. Selection criteria Studies reporting on quality parameters of nine medicines - magnesium sulphate, aspirin, calcium supplements, amlodipine, nifedipine, methyldopa, enalapril, hydralazine and labetalol, using any valid laboratory methods. Data collection and analysis Two reviewers independently screened the studies, extracted data and assessed the quality. Results were reported narratively by type of medicine. Main results Of 5669 citations screened, 33 studies from 27 countries were included. Five quality studies on magnesium sulphate- two (Nigeria and USA) found substandard medicine due to failing API specification and contaminants, respectively. Another study from Nigeria and a multi-country study (10 lower-middle- and low-income countries) found poor-quality due to failing the pH criteria. Seven of eight studies evaluating aspirin found quality issues, including degraded medicines in five studies (Brazil, USA, Yugoslavia and Pakistan). Five studies of calcium supplements found quality issues, particularly heavy metal contamination. Of 15 antihypertensives quality studies, 12 found substandard medicines and one study identified counterfeit medicines. Conclusion We identified multiple findings of poor quality across all types of medicines used in hypertensive disorders of pregnancy, raising concerns regarding their safety and effectiveness.

Yanan Hu

and 6 more

Background: There has been a trend toward birth at earlier gestational age and increased use of both induction of labour (IOL) and caesarean section (CS) for women with term pregnancies in many countries, particularly high-income countries. Unnecessary use of obstetric interventions during pregnancy and birth is associated with an increased risk of adverse health outcomes for women and babies, as well as adding financial costs to the health care systems. Existing evidence regarding the association between IOL at term and CS is mixed and conflicting, and little evidence has been known about the differential effect at each gestation between 37 +0 – 41 +6 weeks, separately among nulliparous and parous women. Objective: The aim of this study was to explore the association between IOL and primary CS for women with singleton term pregnancies, compared with expectant management (EM) of pregnancy. Methods: We performed an analysis of population-based retrospective cohort data on women who gave birth in one Australian state (Queensland), between 01/07/2012 and 30/06/2018. All no-labour births (i.e., prelabour CS), multiple births (e.g., twins or triplets), and women with a prior CS were excluded. Five sub-datasets were created based on the time of birth following IOL (37 +0 - 37 +6; 38 +0 - 38 +6; 39 +0 - 39 +6; 40 +0 - 40 +6; and 41 +0 - 41 +6). Unadjusted relative risk (RR) and adjusted relative risk (aRR) were calculated in each sub-dataset to explore the risk of primary CS following IOL, compared to EM. Analysis was stratified by parity (nulliparas versus paras). Sensitivity analyses were conducted by limiting to women with low-risk pregnancies. Results: The risk of primary CS following IOL was significantly higher for women with singleton pregnancies, compared with EM, before or after adjustment, at 38 +0 - 38 +6 (nulliparas: aRR = 1.14, 95% CI: 1.10 - 1.18; paras: aRR = 1.35, 95% CI: 1.25 - 1.46), at 39 +0 - 39 +6 (nulliparas: aRR = 1.18, 95% CI: 1.14 - 1.22; paras: aRR = 1.36, 95% CI: 1.24 - 1.49), at 40 +0 - 40 +6 (nulliparas: aRR = 1.25, 95% CI: 1.21 - 1.29; paras: aRR = 1.40, 95% CI: 1.26 - 1.56) and at 41 +0 - 41 +6 (nulliparas: aRR=1.42, 95% CI: 1.36 - 1.48; paras: aRR=1.61, 95% CI: 1.40 - 1.84). After adjusting for potential confounders, there was no significant difference in the risk of primary CS at 37 +0 - 37 +6 for nulliparas who had IOL and EM (aRR = 1.03, 95% CI: 0.95 - 1.12). Results remain stable in the sensitivity analyses. Conclusion: Our results demonstrated that the risk of primary CS following IOL was higher at each weeks’ gestation between 38 +0 - 38 +6 – 41 +0 - 41 +6 for both nulliparas and paras with singleton pregnancies, compared with EM, and the risk increased with gestational age. This has important implications to support shared decision making between women and health professionals regarding best clinical management and optimal timing of birth.

Annie Tan

and 7 more

Background: Pharmacological pain management options can relieve women’s pain during labour and birth. Trials of these interventions have used a wide variety of outcomes, complicating meaningful comparisons of their effects. Consensus about key outcomes would facilitate the development of a core outcome set to assess the effectiveness of labour pain management. Objective: To identify all outcomes used in studies of pharmacological pain management interventions during labour and birth. Design: A review of systematic reviews and their included randomised controlled trials was undertaken. Search Strategy: Cochrane CENTRAL was searched to identify all Cochrane systematic reviews describing pharmacological pain management options for labour and birth. Search terms included “pain management”, “labour” and variants, with no limits on year of publication or language. Selection Criteria: Cochrane reviews and randomised controlled trials contained within these reviews were included, provided they compared a pharmacological intervention with other pain management options, placebo or no treatment. Data Collection and Analysis: All outcomes reported by reviews or trials were extracted and tabulated, with frequencies of individual outcomes reported. Main Results: Nine Cochrane reviews and 227 unique trials were included. In total, 148 unique outcomes were identified and categorised into maternal, fetal, neonatal, child, health service, provider’s perspective, or economic outcome domains. Conclusions: Outcomes of pharmacological pain management interventions during labour and birth vary widely between trials. The standardisation of trial outcomes would permit more meaningful comparison between studies. Funding: No external funding was provided. Keywords: Labour and birth; pain management; pharmacological interventions; systematic review