Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials

Objective: To compare the efficacy and safety profile of carbetocin with other uterotonic agents in preventing postpartum hemorrhage.

Methods: PubMed, Web of Science, Scopus and EBSCOhost were searched for relevant randomized controlled trials published until September 2013.

Results: Carbetocin was associated with a significantly reduced need for additional uterotonic agents (RR?=?0.68, 95% CI: 0.55–0.84, I^2?=?4%) compared with oxytocin in women following cesarean delivery. However, with respect to postpartum hemorrhage, severe postpartum hemorrhage, mean estimated blood loss and adverse effects, our analysis failed to detect a significant difference. Studies comparing carbetocin with syntometrine in women undergoing vaginal delivery demonstrated no statistical difference in terms of risk of postpartum hemorrhage, severe postpartum hemorrhage or the need for additional uterotonic agents, but the risk of adverse effect was significantly lower in the carbetocin group.

Conclusions: Carbetocin has been associated with a similar low incidence of adverse effects to oxytocin and at least as effective as syntometrine and may become an alternative uterotonic agent for the prevention of postpartum hemorrhage. Further studies should be conducted to determine the safety and efficacy profile of carbetocin in women with cardiac disorders and to analyze the cost-effectiveness and minimum effective dose of carbetocin.     

Uterine or paracervical lidocaine application for pain control during intrauterine contraceptive device insertion: a meta-analysis of randomised controlled trials

Objective: Systematic review and meta-analysis to assess the effects of uterine or paracervical lidocaine application on pain control during IUD insertion.

Methods: PubMed and five other electronic research databases were searched through 15 November 2017 for RCTs comparing lidocaine treatment vs. a control (placebo or no-intervention) to prevent pain during IUD insertion. Searched terms included ‘IUD insertion’, ‘lidocaine’ and ‘randomised controlled trial’. RCTs evaluating lidocaine treatment before IUD insertion without restriction of language, age and IUD type. Pain measured by visual pain scales at tenaculum placement, IUD insertion and immediate post-IUD insertion. Results of random effects meta-analyses were reported as mean differences (MDs) of visual pain scale (VPS) scores and their 95% confidence intervals (CIs).

Results: Eleven RCTs (n?=?1458 women) reporting paracervical lidocaine block or uterine mucosa lidocaine application before IUD insertion. Lidocaine produced lower VPS scores during tenaculum placement (MD ?0.99, 95% CI: ?1.73 to ?0.26), IUD insertion (MD ?1.26, 95% CI: ?2.23 to ?0.29) and immediate post-IUD insertion period (MD ?1.25, 95% CI: ?2.17 to ?0.33).

Conclusion: Lidocaine treatment was associated with modest reduction of pain during tenaculum placement and after IUD insertion.     

Sterile water injection for labour pain: a systematic review and meta-analysis of randomised controlled trials

Background  Up to one-third of labouring women will experience painful 'back labour'. Sterile water injected lateral to the lumbosacral spine is a simple and well-researched approach to this pain.
Objective  To determine if sterile water injection for low back pain compared to placebo or alternative therapy increased or decreased the rate of Caesarean section.
Search strategy  We performed a literature search with no language restriction in four databases: the Cochrane library, EMBASE (1980–2009), Ovid Medline (1950–2009) and CINAHL (1982–2009).
Selection criteria  We included all randomised controlled trials (RCTs) of sterile water injection for labour pain that included outcomes of interest and original data.
Data collection and analysis  We compared Caesarean section rates among women who received sterile water injection in labour with those who received either placebo treatment or another non-pharmacological treatment modality. Other outcomes included pain scores, use of regional analgesia and women's assessment of treatment. We used Revman 5 for the meta-analysis. Data were entered by one reviewer and independently cross-checked. Pooled outcomes were reported as Relative Risk (RR) or Weighted Mean Difference using Mantel–Haenszel fixed-effects model except when the I ² value >50% indicated significant heterogeneity in which case random-effects model was used.
Main results  We included eight RCTs. The Caesarean section rate was 4.6% in the sterile water injection group and 9.9% in the comparison group ( n  =   828) (RR 0.51, 95% CI: 0.30, 0.87).
Conclusion  We believe that a large RCT should be mounted to validate our findings regarding the impact of sterile water injections on mode of delivery.     

Balloon tamponade in the management of postpartum haemorrhage: a review

Obstetric haemorrhage is a significant contributor to worldwide maternal morbidity and mortality. Guidelines for the management of postpartum haemorrhage (PPH) involve a stepwise escalation of pharmacological and eventual surgical approaches. The method of uterine tamponade using balloons has recently been added to the armamentarium for managing PPH. There are various balloons available including the Bakri, Foley, Sengstaken–Blakemore, Rusch and condom catheter. This paper reviews these uterine tamponade technologies in the management of PPH.     

The effectiveness of reflexology on mental health in cancer patients: A systematic review and meta-analysis of randomised controlled trials

Background and purposeThe current body of research examining the effectiveness of reflexology in patients with cancer have predominantly focused on managing physical symptoms and treatment side effects. This review aimed to synthesise evidence from randomised controlled trials (RCTs) examining the effectiveness of reflexology on mental health outcomes in people with cancer.MethodsRCTs published in English and measuring stress, anxiety, depression or quality of life (QoL) were included. Eligible RCTs were identified through search of MEDLINE, Embase, Emcare, PsycINFO, Scopus, the Cochrane Library, OTseeker, PEDro (18 June 2021) and Google and Google Scholar (21 June 2021). The Critical Appraisal Skills Programme Randomised Controlled Trials Checklist was used to assess risk of bias. Meta-analysis and narrative synthesis were undertaken. The certainty of evidence was assessed by using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework.ResultsFifteen RCTs (1356 adult participants) were included. Evidence for stress and anxiety (primary outcomes), as well as depression and QoL (secondary outcomes), were mixed and conflicting. The certainty of the evidence was low to very low.ConclusionAn unequivocal recommendation supporting reflexology cannot be made. Greater utilisation of well-established reporting guidelines, together with increased investment in well-designed, high-quality clinical research are required.     

The prevalence and risk factors of postpartum depression among women during the early postpartum period: a retrospective secondary data analysis

ObjectivePostpartum depression (PPD) is common and detrimental affecting both maternal health and child development. The purpose of this study was to determine the prevalence and factors of PPD screened immediately after delivery.Materials and methodsA retrospective study design using secondary data analysis is applied. Four years of data, containing linkable maternal, neonate and PPD screen records between 2014 and 2018, was retrieved and combined from the electronic medical systems of MacKay Memorial Hospital in Taiwan. For each woman, the PPD screen record contained self-reported depressive symptoms assessed by the Edinburgh Postnatal Depression Scale (EPDS) within 48–72 h after delivery. A set of factors pertaining to maternal, pregnancy and obstetric, neonatal and breastfeeding were selected from the combined data set.ResultsIn total, 10.2% (1244 of 12,198) of women reported with the symptoms of PPD (EPDS ≥10). Through logistic regression analysis, eight predictors of PPD were identified. Specifically, PPD was shown to be associated with educational level of high school or lower (odds ratio (OR) = 1.57, 95% confidence interval (CI) 1.27–1.93), marital status of unmarried (OR = 1.52, 95% CI 1.18–1.99), unemployed (OR = 1.26, 95% CI 1.11–1.42), Cesarean section (OR = 1.7, 95% CI 1.5–1.93), unplanned pregnancy (OR = 1.38, 95% CI = 1.22–1.57), gestational age at 24–36 weeks (OR = 1.3, 95% CI 1.08–1.56), non-intention of breastfeeding (OR = 1.7, 95% CI 1.18–2.45) and Apgar at 5 min < 7 (OR = 2.18, 95% CI 1.11–4.29).ConclusionLow educational level, unmarried, unemployed, Caesarean section, unplanned pregnancy, preterm delivery, not breastfeeding and low Apgar at 5 min are predictors for postpartum women to develop PPD. These predictors are easily recognized in the clinical environment for patient guidance, support and referral as early as possible to ensure the health and well-being of the mothers and the neonates.     

The effect of early versus delayed postcaesarean feeding on women's satisfaction: a randomised controlled trial

Objective  To evaluate the effect of early versus delayed feeding after caesarean section on the woman's satisfaction.
Design  Randomised, controlled trial.
Setting  Tertiary care hospital.
Population  Healthy pregnant women were enrolled for the study during antenatal care visits.
Methods  Uncomplicated singleton pregnancies undergoing a planned or intrapartum caesarean section performed under regional anaesthesia were randomly assigned to either (1) a 'delayed feeding' group who started oral fluids 4 hours after surgery with diet introduced at 24 hours; or (2) an 'early feeding' group who were offered a regular diet within the first 8 hours.
Main outcome measures  Primary outcome was the woman's satisfaction measured with a visual analogue scale (VAS) before their hospital discharge. The secondary outcomes were: pain, anorexia, abdominal distension, persistent nausea and/or vomiting, time to the first bowel movement and passage of flatus.
Results  Two hundred women were recruited, with 103 randomised to delayed feeding and 97 to early feeding. The woman's satisfaction (mean VAS ± SD) was similar in both groups; 73 ± 17 mm in the delayed feeding group and 77 ± 13 mm in the early feeding group ( P = 0.12). A statistically significant difference was observed in mean postoperative pain: 29 ± 13 mm in the delayed feeding group versus 24 ± 11 mm in the early feeding group ( P = 0.008). No other significant differences in postoperative variables were recorded, and there were no major postoperative complications observed in either group.
Conclusion  Early feeding after uncomplicated caesarean in low-risk women is equivalent in terms of the woman's satisfaction and the reduced perceived pain.     

Intrapartum amnioinfusion for meconium-stained amniotic fluid: a systematic review of randomised controlled trials

BACKGROUND: Amnioinfusion (AI) is thought to dilute meconium when present in the amniotic fluid and so reduces the risk of meconium aspiration. OBJECTIVES: To evaluate if AI reduces meconium aspiration syndrome (MAS) and other indicators of morbidity in babies born to women with meconium-stained amniotic fluid (MSAF). SEARCH STRATEGY: PubMed, Medline, EMBASE, and the Cochrane Controlled Trials Register from January 1980 to May 30, 2005, using the keywords 'amnioinfusion' and 'meconium'. SELECTION CRITERIA: Randomised trials comparing AI with no AI for women in labour with MSAF. Trial quality was evaluated using pre-established criteria. DATA COLLECTION AND ANALYSIS: The following morbidity indicators were assessed: MAS, 5-minute Apgar score < 7, arterial cord pH < 7.2, and caesarean section. Studies were stratified according to the level of peripartum surveillance (standard versus limited). Typical relative risks (RRs) with their 95% confidence intervals were calculated for each outcome using a random effects model. MAIN RESULTS: In clinical settings with standard peripartum surveillance, we found no evidence that AI reduced the risk of MAS (RR 0.59, 95% CI 0.28-1.25), 5-minute Apgar score < 7 (RR 0.90, 95% CI 0.58-1.41), or caesarean delivery (RR 0.89, 95% CI 0.73-1.10). In clinical settings with limited peripartum surveillance, AI appeared to reduce the risk of MAS (RR 0.25, 95% CI 0.13-0.47). CONCLUSION: In clinical settings with standard peripartum surveillance, the evidence does not support the use of AI for MSAF. In settings with limited peripartum surveillance, where complications of MSAF are common, AI appears to reduce the risk of MAS. However, this finding requires confirmation by further studies.     

The levonorgestrel-releasing intrauterine system: its effect on the number of hysterectomies performed in perimenopausal women with uterine fibroids

Abstract

This prospective observational study was designed to determine the percentage of hysterectomies avoided following insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) in perimenopausal women with uterine fibroids and a prior indication for surgery. The study also compared the progress of patients using the LNG-IUS with those submitted to hysterectomy, with particular emphasis on the patient’s satisfaction with treatment. Sixty perimenopausal patients with uterine fibroids and excessive bleeding referred for hysterectomy were included. After counseling on the possibility of non-surgical treatment, 39 patients opted to use an LNG-IUS while 21 opted for hysterectomy. Continuation of LNG-IUS use and the patient’s satisfaction with the chosen procedure were assessed. A secondary analysis evaluated hemoglobin levels, clinical complications, bleeding patterns and uterine volume at ultrasonography over time. After 24 months of follow-up, four of the patients who had opted to use an LNG-IUS were submitted to surgery, while 35 continued using the device, thus avoiding hysterectomy in 89.5% of cases. LNG-IUS users were more satisfied with treatment (p?=?0.02) compared to those submitted to hysterectomy. In conclusion, the use of the LNG-IUS enables the number of hysterectomies to be reduced in women with uterine fibroids and is associated with greater satisfaction compared to surgical treatment.     

A systematic review of telephone support for women during pregnancy and the early postpartum period

OBJECTIVE: To assess the effects of telephone-based support on smoking, preterm birth, low birthweight, breastfeeding, and postpartum depression. DATA SOURCES: Cochrane Pregnancy and Childbirth Group trials register (March 2006), Cochrane Central Register of Controlled Trials (March 2006), Medline (1966-2006), EMBASE (1980-2006), and CINAHL (1982-2006). Secondary references were scanned and experts in the field were contacted. STUDY SELECTION: All published, unpublished, and ongoing randomized controlled trials of telephone support interventions in which the primary aim was smoking, preterm birth, low birthweight, breastfeeding, or postpartum depression were reviewed. DATA EXTRACTION: Data were independently extracted by both authors and double entered into the Cochrane Collaboration's Review Manager (2003) software. DATA SYNTHESIS: Trials evaluating different primary outcomes were analyzed separately. For dichotomous data, results were presented as summary relative risk with 95% confidence intervals. For continuous data, weighted mean difference was used. CONCLUSIONS: Proactive telephone support may (a) assist in preventing smoking relapse, (b) play a role in preventing low birthweight, (c) increase breastfeeding duration and exclusivity, and (d) decrease postpartum depressive symptomatology. No telephone interventions were effective in improving preterm birth or smoking cessation rates. Additional research is encouraged.     

The effect of the levonorgestrel releasing intrauterine system on endometrial hyperplasia: An Australian study and systematic review

Background: The levonorgestrel intrauterine system (LNG-IUS) provides effective contraception and treatment for menorrhagia and is used to prevent endometrial hyperplasia (EH) in women taking unopposed oestrogens.
Aims: The aim of this study was to assess whether the LNG-IUS was also a safe and effective treatment for EH and to conduct a systematic review of the literature.
Methods: A retrospective record review was undertaken in a private gynaecology practice in Brisbane, Australia, and included all women with EH treated with hysterectomy, oral progestins or LNG-IUS between January 2004 and April 2007. Histopathological findings from hysterectomy specimens or endometrial biopsies were used to calculate rates of regression of the EH.
Results: Twenty-one women elected to have a hysterectomy and seven of those (33%) had no persisting hyperplasia at surgery. Twenty-six women had a LNG-IUS inserted at initial hysteroscopy dilatation and curettage or shortly afterwards; seven of those elected to proceed to hysterectomy when their diagnosis was known. Among ten women who used oral progestin treatment, 90% showed initial regression; two with recurrent EH were subsequently treated successfully with LNG-IUS. All 21 women (100%), including one with atypia, treated with LNG-IUS for more than seven weeks had normal endometrial histology on subsequent assessment. No women developed endometrial cancer. Pooled analysis of the published literature gave a 96% regression rate for non-atypical EH treated with LNG-IUS.
Conclusions: These data contribute further evidence that LNG-IUS is a safe and effective method for treating non-atypical EH. Whether LNG-IUS could provide a safe and cost-effective alternative to hysterectomy for atypical EH warrants further examination.     

Tibolone in postmenopausal women: a review based on recent randomised controlled clinical trials

Aim.?To critically discuss the use of tibolone (T), in light of a series of very recent double-blind placebo (PL) controlled trials (LISA, LIFT, OPAL, THEBES, LIBERATE) conducted worldwide in a large number of postmenopausal women (PMW).

Methods.?The most relevant publications on T therapy in PMW were considered with emphasis on menopausal symptoms, quality of life, sexuality, bone, cardiovascular system (CVS) and oncologic risk.

Results.?T significantly relieves climacteric symptoms and improves mood and sexual well-being (LISA). T is as effective as estrogen–progestin therapy in preventing bone loss and reducing the relative risk of vertebral and non-vertebral fractures (LIFT). By using surrogate endpoints of the individual risks for the CVS, studies show mixed results, but a favourable effect on acute miocardial infarction and thromboembolism has been documented (THEBES, LIFT, OPAL). Although findings about endometrial and colon cancer are reassuring, conclusive data on breast cancer risk with T are not available and an increased risk of recurrence in women with previous breast cancer emerged (LIBERATE).

Conclusions.?T is effective in treating menopausal syndrome with a good tolerability profile. In spite of some unsolved issues in term of safety, T is still a good treatment option for early PMW.     

Planned delivery at 37 weeks in twins: a systematic review and meta-analysis of randomized controlled trials

Objective: To evaluate the effects of planned delivery at 37 weeks in women with twin gestations compared to expectant management.

Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Searches were performed in electronic databases. We included all RCTs of uncomplicated early term twin gestations with intact membranes who were randomized to planned delivery at 37 weeks or control (i.e. expectant management until at least 38⁰ weeks). The primary outcome was the rate of cesarean delivery.

Results: Two trials (271 women) were analyzed. Women with twin gestations who had planned delivery at 37 weeks had similar rates of cesarean delivery compared to controls [51.9 versus 49.3%; relative risk (RR): 1.05, 95% confidence interval (CI): 0.83–1.32]. Furthermore, no differences in all secondary outcomes were detected, except for a significantly lower rate of serious adverse infant outcomes in the women who had planned delivery at 37 weeks compared to controls (4.7 versus 12.2%; RR: 0.39, 95% CI: 0.20–0.76).

Conclusions: Planned delivery at 37 weeks in twins is associated with a similar risk of cesarean delivery and lower risk of serious adverse infant outcomes, compared to expectant management until at least 38 weeks.     

Herbal medicine for post-stroke anxiety: A systematic review and meta-analysis of randomized controlled trials

The study was conducted to investigate the efficacy and safety of herbal medicine (HM) for post-stroke anxiety (PSA). Through comprehensive searches, twenty randomized controlled trials were included. Meta-analysis showed that compared to the HM group, the conventional pharmacotherapy group showed significantly lower Hamilton anxiety rating scale (HAMA) score after 1 week of treatment, but not after 2, 4, and 6 weeks of treatment, and higher HAMA score after 8 weeks and 3 months of treatment. Meanwhile, compared to the conventional pharmacotherapy alone group, the HM plus conventional pharmacotherapy group showed significantly better results in HAMA score after 2, 4, 6, and 8 weeks of treatment. HM group was associated with lower incidence of adverse events. Current evidence suggests that HM or HM plus conventional pharmacotherapy may be safe and effective in PSA patients within a certain time period. However, due to limited strength of evidence, definite conclusions are not possible.