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1.
BMJ Open ; 14(5): e079713, 2024 May 08.
Article in English | MEDLINE | ID: mdl-38719306

ABSTRACT

OBJECTIVE: There are no globally agreed on strategies on early detection and first response management of postpartum haemorrhage (PPH) during and after caesarean birth. Our study aimed to develop an international expert's consensus on evidence-based approaches for early detection and obstetric first response management of PPH intraoperatively and postoperatively in caesarean birth. DESIGN: Systematic review and three-stage modified Delphi expert consensus. SETTING: International. POPULATION: Panel of 22 global experts in PPH with diverse backgrounds, and gender, professional and geographic balance. OUTCOME MEASURES: Agreement or disagreement on strategies for early detection and first response management of PPH at caesarean birth. RESULTS: Experts agreed that the same PPH definition should apply to both vaginal and caesarean birth. For the intraoperative phase, the experts agreed that early detection should be accomplished via quantitative blood loss measurement, complemented by monitoring the woman's haemodynamic status; and that first response should be triggered once the woman loses at least 500 mL of blood with continued bleeding or when she exhibits clinical signs of haemodynamic instability, whichever occurs first. For the first response, experts agreed on immediate administration of uterotonics and tranexamic acid, examination to determine aetiology and rapid initiation of cause-specific responses. In the postoperative phase, the experts agreed that caesarean birth-related PPH should be detected primarily via frequently monitoring the woman's haemodynamic status and clinical signs and symptoms of internal bleeding, supplemented by cumulative blood loss assessment performed quantitatively or by visual estimation. Postoperative first response was determined to require an individualised approach. CONCLUSION: These agreed on proposed approaches could help improve the detection of PPH in the intraoperative and postoperative phases of caesarean birth and the first response management of intraoperative PPH. Determining how best to implement these strategies is a critical next step.


Subject(s)
Cesarean Section , Consensus , Delphi Technique , Postpartum Hemorrhage , Humans , Postpartum Hemorrhage/diagnosis , Postpartum Hemorrhage/etiology , Postpartum Hemorrhage/therapy , Female , Cesarean Section/adverse effects , Pregnancy , Early Diagnosis , Tranexamic Acid/therapeutic use
2.
Bull World Health Organ ; 101(11): 723-729, 2023 Nov 01.
Article in English | MEDLINE | ID: mdl-37961052

ABSTRACT

Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.


L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en œuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en œuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.


El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.


Subject(s)
Cesarean Section , Labor, Obstetric , Pregnancy , Female , Humans , Incidence , Delivery, Obstetric , Postpartum Period
4.
J Perinat Med ; 51(1): 135-144, 2023 Jan 27.
Article in English | MEDLINE | ID: mdl-36054840

ABSTRACT

Intrapartum fetal surveillance aims to predict significant fetal hypoxia and institute timely intervention to avoid fetal injury, and do so without unnecessary operative delivery of fetuses at no risk of intrapartum hypoxia. However, the configuration and application of current clinical guidelines inadvertently undermine these aims because of persistent failure to incorporate increased understanding of fetal cardiovascular physiology and adaptations to oxygen deprivation, advances in signal acquisition/processing, and related technologies. Consequently, the field on intrapartum fetal surveillance is stuck in rudimentary counts of the fetal R-R intervals and visual assessment of very common, but nonspecific fetal heart decelerations and fetal heart rate variability. The present authors argue that the time has come to move away from classifications of static morphological appearances of FHR decelerations, which do not assist the thinking clinician in understanding how the fetus defends itself and compensates for intrapartum hypoxic ischaemic insults or the patterns that suggest progressive loss of compensation. We also reappraise some of the controversial aspects of intrapartum fetal surveillance in modern obstetric practice, the current state of flux in training and certification, and contemplate the future of the field particularly in the context of the emerging role of artificial intelligence.


Subject(s)
Fetal Diseases , Labor, Obstetric , Female , Pregnancy , Humans , Labor, Obstetric/physiology , Artificial Intelligence , Fetal Hypoxia/diagnosis , Fetus , Heart Rate, Fetal/physiology , Fetal Monitoring
5.
Arch Dis Child ; 107(7): 644-649, 2022 07.
Article in English | MEDLINE | ID: mdl-34969670

ABSTRACT

The World Health Organization (WHO) has a mandate to promote maternal and child health and welfare through support to governments in the form of technical assistance, standards, epidemiological and statistical services, promoting teaching and training of healthcare professionals and providing direct aid in emergencies. The Strategic and Technical Advisory Group of Experts (STAGE) for maternal, newborn, child and adolescent health and nutrition (MNCAHN) was established in 2020 to advise the Director-General of WHO on issues relating to MNCAHN. STAGE comprises individuals from multiple low-income and middle-income and high-income countries, has representatives from many professional disciplines and with diverse experience and interests.Progress in MNCAHN requires improvements in quality of services, equity of access and the evolution of services as technical guidance, community needs and epidemiology changes. Knowledge translation of WHO guidance and other guidelines is an important part of this. Countries need effective and responsive structures for adaptation and implementation of evidence-based interventions, strategies to improve guideline uptake, education and training and mechanisms to monitor quality and safety. This paper summarises STAGE's recommendations on how to improve knowledge translation in MNCAHN. They include support for national and regional technical advisory groups and subnational committees that coordinate maternal and child health; support for national plans for MNCAHN and their implementation and monitoring; the production of a small number of consolidated MNCAHN guidelines to promote integrated and holistic care; education and quality improvement strategies to support guidelines uptake; monitoring of gaps in knowledge translation and operational research in MNCAHN.


Subject(s)
Adolescent Health , Maternal Health Services , Adolescent , Child , Family , Female , Humans , Infant, Newborn , Nutritional Status , Pregnancy , Translational Science, Biomedical , World Health Organization
6.
J Obstet Gynaecol Res ; 47(9): 3171-3178, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34162016

ABSTRACT

AIM: To compare the efficacy and safety of dinoprostone vaginal insert (DVI) alone versus DVI with adjunctive sweeping of membranes (ASM) for induction of labor (IOL). METHODS: Single-center, prospective, randomized controlled trial; women with singleton term pregnancies, cervical dilation ≥1 and <3 cm, intact membranes allocated to either DVI or DVI with ASM. The primary outcome was vaginal delivery within 24 h of insertion. Secondary outcomes included mean time from insertion to delivery, tachysystole, operative delivery for non-reassuring fetal status (NRFS), tocolytics, fetal outcomes, pain information, and subject satisfaction. RESULTS: One hundred and four received DVI (Group 1) alone and 104 DVI with ASM (Group 2). The rate of vaginal delivery within 24 h was 53% versus 56%, cesarean rate 8.7% versus 10.6% in Groups 1 and 2 respectively. Although the duration of labor was similar in both groups, about 6% of women required additional ripening with dinoprostone vaginal tablets in Group 2 compared to 11.5% in Group 1 (p-value = 0.2). The frequency of hyperstimulation syndrome, failed induction, analgesic requirements, and fetal outcomes were comparable. The majority (83%-86%) in either cohort were satisfied with their labor experience. Multivariate logistic regression demonstrated a slightly better chance for vaginal delivery within 24 h (odds ratio [OR] 1.22 [95% confidence interval, CI 0.65-2.29]; p-value 0.53] for DVI with ASM, although statistically insignificant. Younger maternal age and multiparity (OR 10.36 [95% CI 4.88-23.67]; p-value <0.0001) contributed to successful IOL. CONCLUSION: DVI with ASM is at least as efficacious as DVI for cervical ripening with no increase in morbidity. Although DVI with ASM group less often needed additional dinoprostone tablets to complete the process of IOL (p-value = 0.2), adjunctive sweeping has not been shown to have a significant impact on the duration of labor or mode of delivery.


Subject(s)
Misoprostol , Oxytocics , Administration, Intravaginal , Cervical Ripening , Dinoprostone , Female , Humans , Labor, Induced , Pregnancy , Prospective Studies
7.
BMC Pregnancy Childbirth ; 20(1): 409, 2020 Jul 16.
Article in English | MEDLINE | ID: mdl-32677911

ABSTRACT

BACKGROUND: Post-partum haemorrhage (PPH) is a leading cause of maternal death worldwide. The WOMAN trial assessed the effects of tranexamic acid (TXA) on death and surgical morbidity in women with PPH. The trial recorded 483 maternal deaths. We report the circumstances of the women who died. METHODS: The WOMAN trial recruited 20,060 women with a clinical diagnosis of PPH after a vaginal birth or caesarean section. We randomly allocated women to receive TXA or placebo. When a woman died, we asked participating clinicians to report the cause of death and to provide a short narrative of the events surrounding the death. We collated and edited for clarity the narrative data. RESULTS: Case fatality rates were 3.0% in Africa and 1.7% in Asia. Nearly three quarters of deaths were within 3 h of delivery and 91% of these deaths were from bleeding. Women who delivered outside a participating hospital (12%) were three times more likely to die (OR = 3.12, 95%CI 2.55-3.81) than those who delivered in hospital. Blood was often unavailable due to shortages or because relatives could not afford to buy it. Clinicians highlighted late presentation, maternal anaemia and poor infrastructure as key contributory factors. CONCLUSIONS: Although TXA use reduces bleeding deaths by almost one third, mortality rates similar to those in high income countries will not be achieved without tackling late presentation, maternal anaemia, availability of blood for transfusion and poor infrastructure.


Subject(s)
Antifibrinolytic Agents/administration & dosage , Antifibrinolytic Agents/therapeutic use , Postpartum Hemorrhage/mortality , Tranexamic Acid/therapeutic use , Adult , Africa/epidemiology , Anemia/mortality , Asia/epidemiology , Blood Transfusion , Cause of Death , Cesarean Section , Developing Countries , Europe/epidemiology , Female , Humans , Maternal Mortality , Postpartum Hemorrhage/drug therapy , Postpartum Period , Pregnancy , Pregnancy Outcome/epidemiology , Time Factors , Young Adult
9.
JNMA J Nepal Med Assoc ; 58(221): 1-5, 2020 Jan.
Article in English | MEDLINE | ID: mdl-32335630

ABSTRACT

INTRODUCTION: Nepal Society of Obstetricians and Gynecologists jointly with the Nepalese government and with the support from the International Federation of Obstetrics and Gynecology has implemented an initiative to institutionalize postpartum family planning services in selected major referral facilities of Nepal to address the gap of low uptake of postpartum family planning in Nepal. The aim of the study is to find the prevalence of the service coverage of postpartum contraception in the selected facilities. METHODS: A descriptive cross-sectional study was conducted in seven major referral facilities across Nepal. Data were collected from the hospital records of all women who delivered in these facilities between October 2018 and March 2019. Ethical approval for this study was obtained from Nepal Health Research Council. Data analysis was done with SPSS version 23. RESULTS: Among the 29,072 deliveries from all the facilities, postpartum family planning counseling coverage was 27,301 (93.9%). The prevalence of uptake of Postpartum Intrauterine Device is 1581 (5.4%) and female sterilization is 1830 (6.3%). In total 11387 mothers (52.2%) had the intention to choose a postpartum family planning method. However, 36% of mothers neither used nor had the intention to choose a postpartum family planning method. CONCLUSIONS: The coverage of Postpartum Intrauterine Device counseling service coverage in Nepal is higher in 2018 as compared to 2016-2017 and in other countries implementing Postpartum Intrauterine Device initiatives. However, the prevalence of service coverage of immediate Postpartum Family Planning methods, mainly Postpartum Intrauterine Device in 2018 is lower in Nepal as compared to 2016-2017, and other countries implementing Postpartum Intrauterine Device initiative. More efforts are needed to encourage mothers delivering in the facilities to use the postpartum family planning method.


Subject(s)
Contraception/statistics & numerical data , Counseling , Family Planning Services , Intrauterine Devices/statistics & numerical data , Postpartum Period , Professional Practice Gaps , Adult , Counseling/methods , Counseling/statistics & numerical data , Cross-Sectional Studies , Family Planning Services/methods , Family Planning Services/standards , Female , Health Services Needs and Demand , Humans , Nepal , Pregnancy , Prevalence , Professional Practice Gaps/methods , Professional Practice Gaps/statistics & numerical data , Quality Improvement/organization & administration
11.
Obstet Gynecol ; 135(4): 945-948, 2020 04.
Article in English | MEDLINE | ID: mdl-32168220

ABSTRACT

OBJECTIVE: To evaluate the pharmacokinetics of tranexamic acid after oral administration to postpartum women. METHODS: We conducted a single-center pharmacokinetic study at Teaching Hospital-Jaffna, Sri Lanka, on 12 healthy postpartum women who delivered vaginally. After oral administration of 2 g of immediate-release tranexamic acid 1 hour after delivery, pharmacokinetic parameters were measured on plasma samples at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, and 12 hours. Plasma tranexamic acid concentrations were determined by high-performance liquid chromatography. The outcome measures were maximum observed plasma concentration, time to maximum plasma concentration, time to reach effective plasma concentration, time period effective serum concentration lasted, area under the curve for drug concentration, and half-life of tranexamic acid. RESULTS: The mean maximum observed plasma concentration was 10.06 micrograms/mL (range 8.56-12.22 micrograms/mL). The mean time to maximum plasma concentration was 2.92 hours (range 2.5-3.5 hours). Mean time taken to reach the effective plasma concentration of 5 micrograms/mL and the mean time this concentration lasted were 0.87 hours and 6.73 hours, respectively. Duration for which plasma tranexamic acid concentration remained greater than 5 micrograms/mL was 5.86 hours. Half-life was 1.65 hours. Area under the curve for drug concentration was 49.16 micrograms.h/mL (range 43.75-52.69 micrograms.h/mL). CONCLUSION: Clinically effective plasma concentrations of tranexamic acid in postpartum women may be achieved within 1 hour of oral administration. Given the promising pharmacokinetic properties, we recommend additional studies with larger sample sizes to investigate the potential of oral tranexamic acid for the treatment or prophylaxis of postpartum hemorrhage.


Subject(s)
Antifibrinolytic Agents/pharmacokinetics , Postpartum Hemorrhage/prevention & control , Postpartum Period/blood , Tranexamic Acid/pharmacokinetics , Administration, Oral , Adult , Antifibrinolytic Agents/administration & dosage , Antifibrinolytic Agents/therapeutic use , Chromatography, High Pressure Liquid , Female , Humans , Postpartum Hemorrhage/blood , Pregnancy , Tranexamic Acid/administration & dosage , Tranexamic Acid/therapeutic use , Young Adult
13.
BMC Health Serv Res ; 20(1): 123, 2020 Feb 17.
Article in English | MEDLINE | ID: mdl-32066440

ABSTRACT

BACKGROUND: Family planning services in the post-partum period, termed post-partum family planning (PPFP) is critical to cover the unmet need for contraception, especially when institutional delivery rates have increased. However, the intention to choose PPFP methods such as post-partum intrauterine devices (PPIUD) remains low in countries such as Nepal. Community health workers such as Female Community Health Volunteers (FCHVs) could play an important role in improving the service coverage of PPFP in Nepal. However, their knowledge of PPFP and community-based services related to PPFP remain unclear. This study aims to assess the effect on community-based PPFP services by improving FCHV's knowledge through orientation on PPFP. METHODS: We conducted this mixed-methods study in Morang District in Nepal. The intervention involved orientation of FCHVs on PPFP methods. We collected quantitative data from three sources; via a survey of FCHVs that assessed their knowledge before and after the intervention, from their monthly reporting forms on counseling coverage of women at different stages of pregnancy from the communities, and by interviewing mothers in their immediate post-partum period in two selected hospitals. We also conducted six focus group discussions with the FCHVs to understand their perception of PPFP and the intervention. We performed descriptive and multivariable analyses for quantitative results and thematic analysis for qualitative data. RESULTS: In total, 230 FCHVs participated in the intervention and their knowledge of PPFP improved significantly after it. The intervention was the only factor significantly associated with their improved knowledge (adjusted odds ratio = 24, P < 0.001) in the multivariable analysis. FCHVs were able to counsel 83.3% of 1872 mothers at different stages of pregnancy in the communities. In the two hospitals, the proportion of mothers in their immediate post-partum period whom reported they were counseled by FCHVs during their pregnancy increased. It improved from 7% before the intervention to 18.1% (P < 0.001) after the intervention. The qualitative findings suggested that the intervention improved their knowledge in providing PPFP counseling. CONCLUSION: The orientation improved the FCHV's knowledge of PPFP and their community-based counseling. Follow-up studies are needed to assess the longer term effect of the FCHV's role in improving community-based PPFP services.


Subject(s)
Community Health Workers/education , Family Planning Services/organization & administration , Family Planning Services/standards , Inservice Training , Postpartum Period , Quality Improvement/organization & administration , Volunteers/education , Contraception , Counseling/statistics & numerical data , Female , Focus Groups , Health Knowledge, Attitudes, Practice , Health Services Research , Humans , Intrauterine Devices/statistics & numerical data , Nepal , Qualitative Research , Surveys and Questionnaires
14.
Int J Gynaecol Obstet ; 148(1): 65-71, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31593302

ABSTRACT

OBJECTIVE: To determine maternal outcomes for women with abnormally invasive placenta (AIP) managed using the Triple P Procedure and establish its safety as a conservative surgical management option. METHODS: A retrospective study of the outcomes of the first 50 patients who underwent the Triple P Procedure for AIP from September 2010 to May 2017 at St George's Maternity Unit. Maternity case notes and the database were reviewed to determine the volume of bleeding, procedure-related complications, hysterectomy rate, and postoperative hospitalization. RESULTS: Mean operative blood loss was 2318 mL (range, 400-7300 mL and the incidence of bladder and ureteric injuries was 2% (n=1) and 0%, respectively. Median length of hospital stay was 4 days (range, 2-8 days). Three women (6.0%) developed arterial thrombosis without any long-term complications and none of the patients required peripartum hysterectomy. CONCLUSION: The Triple P Procedure should be considered as a conservative, less risky alternative to a peripartum hysterectomy during counselling prior to surgery for women with AIP.


Subject(s)
Cesarean Section/methods , Conservative Treatment/methods , Placenta Accreta/surgery , Adult , Blood Loss, Surgical/statistics & numerical data , Female , Humans , Length of Stay/statistics & numerical data , Pregnancy , Retrospective Studies
15.
Int J Gynaecol Obstet ; 148(3): 290-299, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31709527

ABSTRACT

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.


Subject(s)
Patient Care Bundles/methods , Postpartum Hemorrhage/therapy , Female , Guideline Adherence , Humans , International Cooperation , Pregnancy , World Health Organization
16.
N Engl J Med ; 380(11): 1012-1021, 2019 03 14.
Article in English | MEDLINE | ID: mdl-30865795

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.).


Subject(s)
Abortion, Spontaneous/surgery , Antibiotic Prophylaxis , Doxycycline/therapeutic use , Metronidazole/therapeutic use , Pelvic Infection/prevention & control , Postoperative Complications/prevention & control , Preoperative Care , Administration, Oral , Adolescent , Adult , Africa South of the Sahara , Developing Countries , Double-Blind Method , Doxycycline/adverse effects , Female , Humans , Metronidazole/adverse effects , Pakistan , Pelvic Infection/epidemiology , Postoperative Complications/epidemiology , Pregnancy , Treatment Outcome
18.
Trials ; 19(1): 712, 2018 Dec 29.
Article in English | MEDLINE | ID: mdl-30594227

ABSTRACT

BACKGROUND: Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, most of which occur in low- and middle-income countries. Tranexamic acid (TXA) reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases blood loss in surgery and reduces death due to bleeding after trauma. When given within 3 h of birth, TXA reduces deaths due to bleeding in women with PPH. However, for many women, treatment of PPH is too late to prevent death. Over one third of pregnant women in the world are anaemic and many are severely anaemic. These women have an increased risk of PPH and suffer more severe outcomes if PPH occurs. There is an urgent need to identify a safe and effective way to reduce postpartum bleeding in anaemic women. METHODS/DESIGN: The WOMAN-2 trial is an international, multicentre, randomised, double-blind, placebo-controlled trial to quantify the effects of TXA on postpartum bleeding in women with moderate or severe anaemia. Ten thousand women with moderate or severe anaemia who have given birth vaginally will be randomised to receive 1 g of TXA or matching placebo by intravenous injection immediately (within 15 min) after the umbilical cord is cut or clamped. The primary outcome is the proportion of women with a clinical diagnosis of primary PPH. The cause of PPH will be described. Data on maternal health and wellbeing, maternal blood loss and its consequences, and other health outcomes will be collected as secondary outcomes. The main analyses will be on an 'intention-to-treat' basis, irrespective of whether the allocated treatment was received. Results will be presented as appropriate effect estimates with a measure of precision (95% confidence intervals). Subgroup analyses will be based on the severity of anaemia (moderate versus severe) and type of labour (induced or augmented versus spontaneous). A study with 10,000 patients will have over 90% power to detect a 25% relative reduction from 10 to 7.5% in PPH. The trial will be conducted in hospitals in Africa and Asia. DISCUSSION: The WOMAN-2 trial should provide reliable evidence for the effects of TXA for preventing postpartum bleeding in women with anaemia. TRIAL REGISTRATION: ISRCTN, ISRCTN62396133 . Registered on 7 December 2017; ClincalTrials.gov, ID: NCT03475342 . Registered on 23 March 2018.


Subject(s)
Anemia/complications , Antifibrinolytic Agents/administration & dosage , Postpartum Hemorrhage/prevention & control , Tranexamic Acid/administration & dosage , Africa , Anemia/blood , Anemia/diagnosis , Antifibrinolytic Agents/adverse effects , Asia , Biomarkers/blood , Double-Blind Method , Female , Hemoglobins/metabolism , Humans , Multicenter Studies as Topic , Postpartum Hemorrhage/diagnosis , Postpartum Hemorrhage/etiology , Pregnancy , Randomized Controlled Trials as Topic , Risk Factors , Time Factors , Tranexamic Acid/adverse effects , Treatment Outcome
19.
Int J Gynaecol Obstet ; 143 Suppl 1: 4-12, 2018 Sep.
Article in English | MEDLINE | ID: mdl-30225869

ABSTRACT

OBJECTIVE: To describe the process of planning and implementing a program of counselling and delivery of postpartum intrauterine devices (PPIUD) in 48 hospitals across six countries in Africa and Asia. METHODS: The process of planning the FIGO PPIUD initiative, selection of countries and hospitals, model of implementation, and lessons for the future are described. RESULTS: Country-level and hospital-based leadership were essential and training-the-trainer models were successful. There was a need for consistency of competency standards allowing for national variations. As the project progressed, additional steps were necessary for steady implementation of the initiative, specifically: establishment of a project steering committee and a data safety monitoring committee, audits of structure and process, and regular feedback of each center's performance to stimulate maintenance and enhancement of activities. Postnatal follow-up was challenging in many countries with fragmented maternity systems. CONCLUSION: The importance of professional leadership and commitment backed by robust data for monitoring and feedback are essential for success.


Subject(s)
Contraception Behavior/statistics & numerical data , Counseling/statistics & numerical data , Family Planning Services/statistics & numerical data , Intrauterine Devices/statistics & numerical data , Long-Acting Reversible Contraception/statistics & numerical data , Postpartum Period , Africa , Asia , Female , Humans , International Cooperation
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