Objective
To develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real‐world need of women and healthcare providers, ...informed by views and agreement amongst globally diverse stakeholders.
Design
Mixed methods.
Setting
Global (with a focus on low‐ and middle‐income countries, LMICs).
Sample
Global stakeholders with diverse expertise in preterm labour/birth and drug development.
Methods
Following an initial literature review, diverse stakeholders were invited to participate in an online international survey and in‐depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs.
Main outcomes measures
Level of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines.
Results
We performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug‐specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree).
Conclusions
There is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings.
Objective
To systematically develop evidence‐based bundles for care of postpartum hemorrhage (PPH).
Methods
An international technical consultation was conducted in 2017 to develop draft bundles of ...clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated “GRADE Evidence‐to‐Decision” framework. Twenty‐three global maternal‐health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6‐month period, the expert panel met online and via teleconferences, culminating in a 2‐day in‐person meeting.
Results
The consultation led to the definition of two care bundles for facility implementation. The “first response to PPH bundle” comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The “response to refractory PPH bundle” comprises compressive measures (aortic or bimanual uterine compression), the non‐pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements.
Conclusion
For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.
Care bundles were defined for first response and refractory PPH. Implementation strategies, refractory PPH definition, and effectiveness of intrauterine balloon tamponade require further consultation.
Objective
To evaluate the use of analgesia during labor in women who had a vaginal birth and to determine the factors associated with its use.
Methods
A secondary analysis was performed of the WHO ...Multicountry Survey on Maternal and Newborn Health, a cross‐sectional, facility‐based survey including 359 healthcare facilities in 29 countries. The prevalence of analgesia use for vaginal birth in different countries was reported according to the Human Development Index (HDI). Sociodemographic and obstetric characteristics of the participants with and without analgesia were compared. The prevalence ratios were compared across countries, HDI groups, and regions using a design‐based χ2 test.
Results
Among the 221 345 women who had a vaginal birth, only 4% received labor analgesia, mainly epidural. The prevalence of women receiving analgesia was significantly higher in countries with a higher HDI than in countries with a lower HDI. Education was significantly associated with increased use of analgesia; nulliparous women and women undergoing previous cesarean delivery had a significantly increased likelihood of receiving analgesia.
Conclusion
Use of analgesia for women undergoing labor and vaginal delivery was low, specifically in low‐HDI countries. Whether low use of analgesia reflects women’s desire or an unmet need for pain relief requires further studies.
Synopsis
The use of analgesia is very low worldwide, especially in low‐income countries.
Magnesium sulfate is the anticonvulsant of choice for eclampsia prophylaxis and treatment; however, the recommended dosing regimens are costly and cumbersome and can be administered only by skilled ...health professionals. The objectives of this study were to develop a robust exposure‐response model for the relationship between serum magnesium exposure and eclampsia using data from large studies of women with preeclampsia who received magnesium sulfate, and to predict eclampsia probabilities for standard and alternative (shorter treatment duration and/or fewer intramuscular injections) regimens. Exposure‐response modeling and simulation were applied to existing data. A total of 10 280 women with preeclampsia who received magnesium sulfate or placebo were evaluated. An existing population pharmacokinetic model was used to estimate individual serum magnesium exposure. Logistic regression was applied to quantify the serum magnesium area under the curve‐eclampsia rate relationship. Our exposure‐response model‐estimated eclampsia rates were comparable to observed rates. Several alternative regimens predicted magnesium peak concentration < 3.5 mmol/L (empiric safety threshold) and eclampsia rate ≤ 0.7% (observed response threshold), including 4 g intravenously plus 10 g intramuscularly followed by either 8 g intramuscularly every 6 hours × 3 doses or 10 g intramuscularly every 8 hours × 2 doses and 10 g intramuscularly every 8 hours × 3 doses. Several alternative magnesium sulfate regimens with comparable model‐predicted efficacy and safety were identified that merit evaluation in confirmatory clinical trials.
Aim. To evaluate the use of analgesia for vaginal birth, in women with and without severe maternal morbidity (SMM) and to describe sociodemographic, clinical, and obstetric characteristics and ...maternal and perinatal outcomes associated with labor analgesia. Methods. Secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health (WHO-MCS), a global cross-sectional study performed between May 2010 and December 2011 in 29 countries. Women who delivered vaginally and had an SMM were included in this analysis and were then divided into two groups: those who received and those who did not receive analgesia for labor/delivery. We further compared maternal characteristics and maternal and perinatal outcomes between these two groups. Results. From 314,623 women originally included in WHO-MCS, 9,788 developed SMM and delivered vaginally, 601 (6.1%) with analgesia and 9,187 (93.9%) without analgesia. Women with SMM were more likely to receive analgesia than those who did not experience SMM. Global distribution of SMM was similar; however, the use of analgesia was less prevalent in Africa. Higher maternal education, previous cesarean section, and nulliparity were factors associated with analgesia use. Analgesia was not an independent factor associated with an increase of severe maternal outcome (Maternal Near Miss + Maternal Death). Conclusions. The overall use of analgesia for vaginal delivery is low but women with SMM are more likely to receive analgesia during labor. Social conditions are closely linked with the likelihood of having analgesia during delivery and such a procedure is not associated with increased adverse maternal outcomes. Expanding the availability of analgesia in different levels of care should be a concern worldwide.
Global perspectives on elective induction of labor Vogel, Joshua P; Gülmezoglu, Ahmet M Metin; Hofmeyr, George J ...
Clinical obstetrics and gynecology,
2014-June, Letnik:
57, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Elective labor induction is an increasingly common practice not only in high-income countries, but also in many low-income and middle-income countries. Many questions remain unanswered on the safety ...and cost-effectiveness of elective labor induction, particularly in resource-constrained settings where there may be a high unmet need for medically indicated inductions, as well as limited or no access to appropriate medications and equipment for induction and monitoring, comprehensive emergency obstetric care, safe and timely cesarean section, and appropriate supervision from health professionals. This article considers the global perspective on the epidemiology, practices, safety, and costs associated with elective labor induction.
Surgical intervention is needed in some cases of spontaneous abortion to remove retained products of conception. Antibiotic prophylaxis may reduce the risk of pelvic infection, which is an important ...complication of this surgery, particularly in low-resource countries.
We conducted a double-blind, placebo-controlled, randomized trial investigating whether antibiotic prophylaxis before surgery to complete a spontaneous abortion would reduce pelvic infection among women and adolescents in low-resource countries. We randomly assigned patients to a single preoperative dose of 400 mg of oral doxycycline and 400 mg of oral metronidazole or identical placebos. The primary outcome was pelvic infection within 14 days after surgery. Pelvic infection was defined by the presence of two or more of four clinical features (purulent vaginal discharge, pyrexia, uterine tenderness, and leukocytosis) or by the presence of one of these features and the clinically identified need to administer antibiotics. The definition of pelvic infection was changed before the unblinding of the data; the original strict definition was two or more of the clinical features, without reference to the administration of antibiotics.
We enrolled 3412 patients in Malawi, Pakistan, Tanzania, and Uganda. A total of 1705 patients were assigned to receive antibiotics and 1707 to receive placebo. The risk of pelvic infection was 4.1% (68 of 1676 pregnancies) in the antibiotics group and 5.3% (90 of 1684 pregnancies) in the placebo group (risk ratio, 0.77; 95% confidence interval CI, 0.56 to 1.04; P = 0.09). Pelvic infection according to original strict criteria was diagnosed in 1.5% (26 of 1700 pregnancies) and 2.6% (44 of 1704 pregnancies), respectively (risk ratio, 0.60; 95% CI, 0.37 to 0.96). There were no significant between-group differences in adverse events.
Antibiotic prophylaxis before miscarriage surgery did not result in a significantly lower risk of pelvic infection, as defined by pragmatic broad criteria, than placebo. (Funded by the Medical Research Council and others; AIMS Current Controlled Trials number, ISRCTN97143849.).
Summary Background Macrosomia is a risk factor for adverse delivery outcomes. We investigated the prevalence, risk factors, and delivery outcomes of babies with macrosomia in 23 developing countries ...in Africa, Asia, and Latin America. Methods We analysed data from WHO's Global Survey on Maternal and Perinatal Health, which was a facility-based cross-sectional study that obtained data for women giving birth in 373 health facilities in 24 countries in Africa and Latin America in 2004–05, and in Asia in 2007–08. Facilities were selected by stratified multistage cluster sampling and women were recruited at admission for delivery. We extracted data from the medical records with a standardised questionnaire. We used logistic regression with random effects to assess the risk factors for macrosomia and the risks for caesarean section and adverse maternal and perinatal outcomes (assessed by a composite score) in babies with the disorder. Findings Of 290 610 deliveries, we analysed data for 276 436 singleton livebirths or fresh stillbirths. Higher maternal age (20–34 years), height, parity, body-mass index, and presence of diabetes, post-term pregnancy, and male fetal sex were associated with a significantly increased risk of macrosomia. Macrosomia was associated with an increased risk of caesarean section because of obstructed labour and post-term pregnancy in all regions. Additionally, macrosomia was associated with an increased risk of adverse maternal birth outcomes in all regions, and of adverse perinatal outcomes only in Africa. Interpretation Increasing prevalence of diabetes and obesity in women of reproductive age in developing countries could be associated with a parallel increase in macrosomic births. The effect and feasibility of control of diabetes and preconception weight on macrosomia should be investigated in these settings. Furthermore, increased institutional delivery in countries where rates are low could be crucial to reduce macrosomia-associated morbidity and mortality. Funding None.
WHO develops evidence-based guidelines for setting global standards and providing technical support to its Member States and the international community, as a whole. There is a clear need to ensure ...that WHO guidance is relevant, rigorous and up-to date. A key activity is to ascertain the guidance needs of the countries. This study provides an international comparison of priority guidance needs for maternal and perinatal health. It incorporates data from those who inform policy and implementation strategies at a national level, in addition to targeting those who use and most need the guidance at grassroot level.
An online multi-country survey was used to identify WHO guidance priorities for the next five years in the field of maternal and perinatal health. WHO regional and country offices were requested to respond the survey and obtain responses from Ministries of Health around the world. In addition, the survey was disseminated through other networks and relevant electronic forums.
A total of 393 responses were received, including 56 from Ministries of Health and 54 from WHO/UN country offices. 75% of responses were from developing countries and 25% from developed countries. Guidance on strategies focusing on 'quality of care' issues to reduce all-cause maternal/perinatal mortality was considered the most important domain to target, which includes for instance guidance to improve access, dissemination, implementation of effective practices and health professionals' education.
This study provides a panorama of international priority guidance needs for maternal and perinatal health. Although clinical guidance remains a priority, there are other areas related to health systems guidance, which seem to be even more important. Overall, the domain ranked highest in terms of greatest need for guidance was around quality of care, which included questions related to educational needs, access to and implementation of guidance.
PDF
