Paracervical block as pain treatment during second-trimester medical termination of pregnancy: an RCT with bupivacaine versus sodium chloride.

STUDY QUESTION: Can paracervical block (PCB) administered before the onset of pain decrease women's pain experience during second-trimester medical termination of pregnancy (MToP)? SUMMARY ANSWER: There were no clinically significant differences between groups receiving PCB with bupivacaine or saline with regard to the highest and lowest pain intensity, morphine consumption or induction-to abortion interval. WHAT IS KNOWN ALREADY: The most common side effect of misoprostol is pain; nevertheless, there are sparse studies in pain and pain treatment during MToP, especially in second-trimester abortion. Pain reported in second-trimester medical abortion is often intense, and peaks when the fetal expulsion occurs. STUDY DESIGN, SIZE, DURATION: A double-blinded RCT was carried out from May 2012 until April 2015. A power calculation was based on a previous pilot study showing that the proportion of women with severe pain [visual analogue scale (VAS) ≥7] was 63%. A clinically significant reduction was considered to yield 35% with severe pain, and with a power of 80% and significance level of 5% (two-sided) 112 women were needed. Accounting for a 20% drop-out rate, a total of 140 women were needed. The primary outcome, pain intensity measured as any VAS ≥7, was analysed using a generalized estimating equations model. The level of significance was set to P < 0.05 two-sided. A computer generated randomization list with block size of 10 was used. The treatment allocation was placed in a sealed, opaque, envelope and picked consecutively. PARTICIPANTS/MATERIALS, SETTING, METHODS: A total of 589 women attending a gynaecological clinic had a second-trimester abortion during the study period and 276 were invited to participate. A total of 113 women undergoing abortion from 13 weeks of gestation and above were recruited, of which 55 were randomly allocated to receive a PCB with bupivacaine and 58 a PCB with sodium chloride 1 h after the first dose of misoprostol. The full analysis set (FAS) population was defined as all randomized women that had at least one value for any of the outcomes (n = 102). The per-protocol (PP) population was defined as a subset of the FAS excluding patients with major protocol deviations or without a value for the primary outcome (n = 99). Pain was measured by VAS at misoprostol initiation (baseline) and repeated every 30 min until fetal expulsion. The primary outcome was the highest VAS pain intensity at any time point. MAIN RESULTS AND THE ROLE OF CHANCE: The highest pain intensity, did not show any differences at a cut-off of VAS ≥7 [risk ratio (RR): 1.1; 95% confidence interval (CI): 0.9-1.5; P = 0.0.292]. In the PP analyses, there were 75% women in the bupivacaine group and 64% in the sodium chloride group with VAS ≥7 (RR: 1.2; 95% CI: 0.9-1.5; P = 0.235). Most women did not experience pain at the misoprostol start, 19 women scored a VAS of >0, ranging from 1 to 4 with a mean of 1.8 and median of 2 (P = 1.000). Immediately prior to PCB, 61 women scored a VAS of >0, from 1 to 10 with a mean of 2.0 and median of 1 (P = 0.771). There was a 48% loss of VAS scores at the time of expulsion and the remaining scores did not differ between groups (RR: 1.5; 95% CI: 0.9-2.5). A subgroup analysis of primipara did not show any difference in highest pain intensity VAS ≥7 (RR: 1.2; 95% CI: 0.9-1.6; P = 0.283). No statistically significant differences were observed between groups with regard to the highest and lowest (P = 553 and 0.182) pain intensity and morphine consumption (P = 0.772). Side effects were reported by 28 women (14 women in each group), with no differences between groups. Most common was nausea and vomiting in connection to morphine injection. LIMITATIONS, REASONS FOR CAUTION: Nearly 60% of the invited women did not want to participate in the study (fear of needles and fear of receiving the placebo) therefore women who tolerate pain may have been overrepresented in the study population. Data collection was stopped, in error, when 113 participants had been recruited. The loss to follow-up was, however, only 11 women (10%), which was lower than expected but intrinsically the study did not fully reach the intended number of women, which may have influenced the results. In addition, the obstetrical and gynaecological background of participating women differs. The participants were informed that they had a 50% chance of receiving a PCB with active substance, which could theoretically have affected their expectations and pain experience (placebo effect). The frequent attention at VAS scoring and the overall care provided may also have affected the participants in a positive way, and helped women to feel supported and more relaxed during the abortion. WIDER IMPLICATIONS OF THE FINDINGS: The highest pain intensity was severe (VAS: 7-10) among 65-75% of the participants, as reported for first-trimester medical abortion; however, the maximal pain scores remain high despite the PCB. There is, therefore, a clear need for more optimal pain treatment but only limited data exist on pain treatment during MToP over all gestational lengths. As PCB was well tolerated, did not cause any serious side effects and had no negative impact on the abortion process and efficacy, another approach may be worth exploring, namely PCB given on demand at the onset of painful contractions. STUDY FUNDING/COMPETING INTERESTS: The study was supported by grants from the Swedish Research Council (grant no: 2012-2844), ALF (Karolinska Institutet - Stockholm County Council, Agreement on Medical Research and Training) funding, the Karolinska Institutet, Stockholm South General Hospital, and Swedish Nurses in the Area of Pain - SSOS together with GlaxoSmithKline. None of the authors have any conflicts of interest. TRIAL REGISTRATION NUMBER: The trial was registered with ClinicalTrials.gov (identifier: NCT01617564) and The EudraCT (number: 2010-020780-21) and was approved by The Regional Ethical Review Board at Karolinska Institutet (dnr: 2007/1277-31/2 and 2010/410-31/1). TRIAL REGISTRATION DATE: Clinical trial registration was done in May 2012 before initiation of patient recruitment. DATE OF FIRST PATIENT'S ENROLMENT: 29 May 2012.

Biogas production from crop residues on a farm-scale level in Sweden: scale, choice of substrate and utilisation rate most important parameters for financial feasibility.

Anaerobic digestion would enable the energy potential of agricultural crop residues such as ley crops and sugar beet tops to be harnessed in Sweden. In the present study, the financial prospects of single-stage fed-batch high-solids digestion on three different scales, 51, 67, and 201 kW, were calculated on the basis of experimental results and observations. In addition to scale, the effects of methane yield and fertiliser recovery (compared to green manuring) was investigated by testing different substrate mixtures. The biogas was disposed as heat, combined heat and power, or as vehicle fuel. Besides the positive effect of scale, the results indicate the importance of choosing substrates with a high methane yield and high nitrogen content, and the necessity of fully utilising both the capacity of the equipment installed and the energy carriers produced. Net unit costs of 5.3 and 8.1 ct/kWh were achieved (201 kW), heat and vehicle fuel, respectively.

Biogas production from crop residues on a farm-scale level: is it economically feasible under conditions in Sweden?

Anaerobic digestion would enable the energy potential of agricultural crop residues such as sugar beet tops and straw to be harnessed. Sweden is so spread out that full utilisation of this potential by centralised slurry-based technology is difficult. It appears that simple but effective high-solids reactor systems have a better chance of being economically viable on a farm-scale level (50-500 kW). In the present study, the financial prospects of high-solids digestion, using either single-stage fed-batch or two-stage batch reactor systems, are compared on a farm-scale level (50 kW) with those of conventional slurry digestion, on the basis of experimental results and observations on a laboratory- and pilot-scale. The gas produced can be used for heat, combined heat and power or as vehicle fuel. The results indicate high-solids single-stage fed-batch operations to stand the best chances of being competitive, particularly in connection with organic farming. The methane yield, degree of gas utilisation, and operational costs were found to have the strongest impact on the financial success of the process.

Tanzanian midwives' views on becoming a good resource and support person for postpartum women.

OBJECTIVES: to explore midwives' views in relation to the provision of systematic postpartum care. DESIGN: qualitative focus group study using grounded theory approach. SETTING: Dar es Salaam, Tanzania. PARTICIPANTS: 49 nurse/midwives in five focus group discussions, each having 9-11 participants. FINDINGS: eight categories were identified: 'reflecting', 'getting ready', 'defining abilities', 'networking', 'integrating', 'balancing', 'dealing with reality', and 'caring'. The identified core category that integrated and encapsulated all other categories was 'becoming a good resource and support person for postpartum woman'. The mediating factors found to have potential for influencing how a midwife can function in order to become a good resource and support person were: a) the structure and approach in maternal and child health services, b) midwives' knowledge, attitude and skills, c) informal sources of knowledge to parents, and d) cultural beliefs and practices. CONCLUSION: the findings of this study provide an understanding of the way midwives feel and think about the provision of postpartum care. The findings demonstrate that midwives need support in their efforts to achieve what they consider necessary for postpartum care. Interventions for educating and supporting midwives should be targeted at enabling them to deal with all the factors that influence their role and help them to identify and use better strategies to provide quality care.

Change in maternal concerns during the 6 weeks postpartum period: a study of primaparous mothers in Dar es Salaam, Tanzania.

The purpose of this study was to describe the postpartum concerns of primiparas. A cohort study included 79 mothers in Dar es Salaam, Tanzania. Mothers sorted topics into worry, interest, and confidence. Trends of decreasing worry and increasing interest and confidence for baby-related and mother-related topics were observed from 1 to 6 weeks. At 1 week mothers worried about baby's eyes, respiration, temperature, safety, and crying; but, at 6 weeks only crying was a problem. Need for information was constant about general health, baby behavior, and care of the baby. At 1 week mothers worried about swollen perineum, and feeling tired and nervous. They wanted information about preventing hemorrhage and infection and taking care of the perineum, breasts, and nipples. Trends of increasing worry and decreasing confidence were observed with respect to family relationships. At 6 weeks, mothers worried about the husband/partner's reaction to themselves and to the baby. Confidence in relatives' reaction to themselves and the baby decreased. Being aware of the changes in the way concerns are expressed may guide nursing/midwifery interventions for mothers as to the content and timing.

The lived experiences of autonomous Angolan midwives working in midwifery-led, maternity units.

OBJECTIVE: to describe the lived experiences of autonomous midwives working in Angolan midwifery-led maternity units. DESIGN: a qualitative approach using semi-structured, audiotaped interviews, in Portugese. Data were analysed in a six-step process. SETTING: three midwifery-led maternity units in the most densely populated suburbs in the capital of Angola, Luanda. The average number of deliveries per unit was 2500 per year. PARTICIPANTS: 11 midwives from the three maternity units. FINDINGS: four main areas emerged: society/culture, significant others, personal self and professional self. Sub-areas, concepts and supporting statements were defined in each area. KEY CONCLUSIONS: the midwives served within a population living in rough circumstances but which maintained strong traditional roots. The midwives did not support homebirths, but did assist when needed. The midwives described their professional role as a 'calling', which was very independent. Cure, was considered more important than care, and strong emotions were expressed when discussing cases of failure. The partograph was viewed as an important instrument and continuous learning as crucial in their role as autonomous midwives. IMPLICATIONS FOR PRACTICE: the model of a midwifery-led delivery unit described in this study may be used in other countries facing the same problems as Angola. Difficulties concerning transfer should be seriously considered as well as adequate education for the midwives. A pre-requisite in order for peripheral maternity units to have any impact on maternal morbidity and mortality, is a well-organised first-referral level.

Evaluation of an adapted model of the World Health Organization partograph used by Angolan midwives in a peripheral delivery unit.

OBJECTIVE: To study the impact of an educational intervention of midwives' use of the Angolan model of the World Health Organization's (WHO) partograph. SETTING: A peripheral delivery unit with approximately 1500 deliveries per year, run by eleven midwives in Luanda, Angola. DESIGN: The quasi-experimental, One-Group Pre-test-Post-test design was used in this study. Fifty partographs plotted with an initial dilatation < 8 cm were randomly selected from the first period of six month to form sample I, and another fifty from the second six-months period to form sample II. INTERVENTION: In-service education (theory and practice) performed by a team of midwives and an obstetrician. MEASUREMENTS AND FINDINGS: When comparing sample II with sample I, statistically significant improvements were found in seven of 10 measured variables. This indicates a positive effect of the educational intervention on a proper use of the partograph. Due to the small sample size, however, this study cannot evaluate action taken in relation to prolonged labour. IMPLICATIONS FOR PRACTICE: The in-service educational programme may be of use when introducing the WHO partograph in similar settings, and the findings of this study may indicate which parts of the programme need more emphasis. CONCLUSIONS: The midwives improved in general their documentation of the partograph. However, they tended to exceed established criteria for responsibilities at the peripheral delivery unit, a fact supported by an increased number of missed transfers. The study did not, however, answer the question why the midwives acted as they did in the referred cases.

Maternal and infant health problems after normal childbirth: a randomised controlled study in Zambia.

STUDY OBJECTIVES: The main aim of the study was to discover if a midwife home visiting programme has a significant effect on the prevalence of health problems and breast feeding behaviour of mothers who delivered normally and their healthy fullterm newborn babies, during a period of 42 days after delivery. Another aim was to compare the mothers', the midwife's, and the doctor's findings of prevalence of health problems at the end of the puerperium period. DESIGN: A randomised controlled trial was carried out. One group of mothers and their infants were randomly allocated to a home visiting group (Group A); the other group (Group B) was only visited at day 42. SETTING: The study was carried out at the University Teaching Hospital (UTH) in Lusaka, the capital city of Zambia. PARTICIPANTS: A total of 408 mothers who had a normal delivery and gave birth to a healthy fullterm infant, as assessed by the attending midwife, were randomised to two groups. Group A consisted of 208 mother/infant dyads who were visited by a midwife in their homes at days 3, 7, 28, and 42 after delivery and Group B consisted of 200 mother/infant dyads who were only visited at day 42. MAIN RESULTS: At day 42 an equal proportion (30%) of mothers in both groups perceived that they had health problems. The prevalence of infant health problems in Group B was significantly higher (p < 0.01) as perceived by mothers. There were more mothers in Group B (p < 0.01) perceiving insufficient milk production and giving supplementary feeding. At day 42, mothers in Group A (56%) took more actions than mothers in Group B (41%) to solve infant health problems (p < 0.03). In both groups the mothers' perceived own health problems, were significantly higher (p < 0.01) than those observed by the obstetrician and those observed by the midwife. The midwife found more infant health problems in Group B (p < 0.01) than in Group A and more infants with health problems in both groups compared with the paediatrician's findings (p < 0.01). CONCLUSIONS: There was a significant difference between the mothers' reported health problems and the health problems identified by the midwife and the doctors. The study shows that a midwife home visit and individual health education to mothers, reduce the prevalence of infant health problems, and enables the mother to more often take action when an infant health problem is identified. There is a need to re-evaluate the midwifery training curriculums with the intention to include more infant management care.

Soothing effect of amniotic fluid smell in newborn infants.

Newborn young of several mammalian species are attracted to the odor of amniotic fluid (AF); these chemical cues also appear to calm neonates and help them adapt to their novel postnatal environment. AF odor likewise elicits positive (head orientation) responses by human infants. The present study systematically examined whether the odors of AF and mother's breasts influence the crying of the newborn infant, when separated from its mother. The total crying time from 31-90 min postnatal was registered on tapes in 47 healthy fullterm newborns, allocated to one of three conditions; exposure to either AF or breast odor or no exposure (controls). Babies exposed to AF smell cried significantly less (median 29 s) than babies in the two other groups (breast odor--301 s, controls--135 s). The data are consistent with the hypothesis that the fetus may become familiar with chemical cues present in the intrauterine environment. Our data provide new evidence of the human baby's fine olfactory discrimination capacity, and add to the growing body of evidence indicating that naturally occurring odors play an important role in the mediation of infants' early behavior.

Family planning practices before and after childbirth in Lusaka, Zambia.

A total of 408 randomly selected normally delivered women who had given birth to healthy infants were recruited from a postnatal ward at the University Teaching Hospital (UTH) in Lusaka, Zambia. Family planning practices before and after pregnancy and delivery were investigated among 376 of these women. The interviews were conducted in their homes or at the postpartum clinic at the UTH at the end of puerperium. The remaining 32 women, mainly primiparae, were lost to follow-up. Thirty four percent of the women had used a family planning method before the present childbirth. Most of those (90%) had used modern methods. Women with eight and more years of education used modern contraceptive methods more often than those with less education. One year after delivery, 64% of the women were using modern or traditional family planning methods. Of those who used traditional methods, 15% relied on lactational amenorrhoea. Of those who did not use any method, 39% indicated that their husbands did not allow them. Fifty-six per cent of the teenagers stated that they had no knowledge of family planning, whereas 84% of the single teenagers had not used contraceptives before. In view of this, teenagers and single mothers need a special focus in the development of family planning programmes. We also recommend that more research should focus on views of both men and women on contraceptive use.

PIP: This article presents an analysis of contraceptive usage before and after childbirth among 376 women (out of a total of 408 randomly selected women) delivering at the University Teaching Hospital in Lusaka, Zambia, during 1989-90. 90% of the original 408 women were married and living with their husbands. 75% lived in the high-density districts of Lusaka. 60% were housewives, and 22% had regular wage employment. 80% of husbands had regular paid employment. 66% reported knowledge of at least one contraceptive method; 34% had no contraceptive knowledge. 97% of those with some knowledge knew about modern methods. 56% of adolescents were unaware of any contraceptive method. 67% did not use any contraceptives. Of the 33% who used a method, 90% used a modern one. 84.4% of unmarried teenagers had not used contraceptives before the study. 58.4% stopped contraceptive use in order to conceive. After 1 year, 64% of 309 women were using contraceptives, of which 55% used a modern method. The most commonly used method was the pill. 17% of the 89 women who used traditional methods relied on lactational amenorrhea. 92% were still breast feeding (2-11 feeds in a 24-hour period) at the end of a year. 47% were menstruating. 68% had resumed sexual relations. 39% of the women at the end of the year who did not use contraception reported that husbands did not allow this practice. 22 women reported that their infant died within the year. Women with 8 or more years of education were more likely to use modern contraception. Contraceptive knowledge and use was influenced by parity, education, marital status, and age. Women mainly asked about what contraceptive methods were available, when to start use, and where to obtain contraception.

Fathers can effectively achieve heat conservation in healthy newborn infants.

The aim of the present study was to compare axillar and skin temperatures and metabolic adaptation in healthy, fullterm elective caesarean section delivered infants who were randomized to be cared-for either in (a) an incubator, (b) a cot, or (c) skin-to-skin with the father. Forty-four infants were studied. The mean axillary temperature increase was significantly greater in the skin-to-skin cared-for infants than in the cot cared-for group. There were no significant difference in mean temperature increase between skin-to-sin cared-for and incubator cared-for infants. Blood glucose increase was significant in the skin-to-skin group, but not in the other groups. The catecholamine levels at 120 min after birth were all within normal range, and there were no differences between the three groups, suggesting that none of the groups was exposed to cold stress. Interestingly, at 24 h after birth the mean axillary temperature was significantly higher in the skin-to-skin group than in the incubator group. It can be concluded that fathers can effectively achieve heat conservation in healthy fullterm caesarean section delivered infants.

Crying in separated and non-separated newborns: sound spectrographic analysis.

During the first 1-2 h after birth crying occurs during separation from the mother and stops on reunion. In rats, such "separation distress calls" have distinct phonetic properties. We examined this early crying by sound spectrography in 29 healthy, full-term, vaginally delivered babies, randomly assigned either to be kept in a cot or to be placed in body contact with the mother during the 90 min following birth. The former babies cried almost 10 times more than the latter ones. The duration of the cry signal (the smallest element of a cry analysed by spectrography) in both groups was 0.8-09s; the melody contour was flat or slightly rising--falling with a fundamental frequency of around 500 hertz. The cry is provisionally characterized as a discomfort cry, elicited mainly by separation from the mother.

The effect of routine hospital care on the health of hypothermic newborn infants in Zambia.

A prospective cohort study was carried out at the University Teaching Hospital, Lusaka, Zambia, to investigate the prevalence of neonatal hypothermia, type of infant care and incidence of mortality. Two-hundred-and-sixty-one infants, aged 0-7 days, admitted to the pediatric unit during the 'warm' season were recruited to the study. Forty-four per cent of the infants were hypothermic (< 36 degrees C) on admission, and admission hypothermia correlated to admission weight and home delivery in the youngest age group (0-24 hours). Exclusively breastfed infants (age group 1-7 days) were less likely to be hypothermic at admission. 'Hypothermia' was not recorded as an admission diagnosis and no special attention was given to those infants in terms of clinical management. Mean time to reach a body temperature above 35.9 degrees C did not differ between infants kept in a cot and in an incubator. Total numbers of death was 82 (31 per cent) and the mortality was higher in infants who were hypothermic at admission compared to those who were not. This study demonstrates that a change of existing care routines is needed.

Separation distress call in the human neonate in the absence of maternal body contact.

Few studies have used the baby's cry as a means of evaluating the quality of neonatal care. In this randomized trial the newborn's cry was registered during the first 90 min after birth when infants were cared for either: (a) skin-to-skin with the mother; (b) in a cot; or (c) in a cot for the first 45 min of the 90-min observation period and then skin-to-skin with the mother. The results suggested that human infants recognize physical separation from their mothers and start to cry in pulses. Crying stops at reunion. The observed postnatal cry may be a human counterpart to the "separation distress call" which is a general phenomenon among several mammalian species, and serves to restore proximity to the mother. Our results suggest that in human newborns this cry is not dependent on earlier social experience and may be a genetically encoded reaction to separation. The findings are compatible with the opinion that the most appropriate position of the healthy full-term newborn baby after birth is in close body contact with the mother.

Lower body temperatures in infants delivered by caesarean section than in vaginally delivered infants.

Clinical experience suggests that infants delivered by caesarean section have difficulties maintaining normal body temperature during the first hours after birth. To test this hypothesis, body and skin temperatures were measured and compared in healthy full-term caesarean section and vaginally delivered newborn infants. The babies were studied during the first 90 min after birth. Axillary and skin temperatures were significantly higher in the vaginally delivered group than in infants delivered by caesarean section. Infants born by non-elective caesarean section were slightly warmer during the first 90 min after birth compared to infants born by elective caesarean section. There were no significant differences in temperatures between infants cared for in a cot as compared to those cared for in an incubator. An incubator creates a physical barrier between babies and parents and incubator care might cause parental anxiety. Thus the routine of putting healthy, full-term caesarean section infants in incubators can be abandoned from a thermoregulatory point of view.

Temperature, metabolic adaptation and crying in healthy full-term newborns cared for skin-to-skin or in a cot.

The aim of the present study was to compare temperatures, metabolic adaptation and crying behavior in 50 healthy, full-term, newborn infants who were randomized to be kept either skin-to-skin with the mother or next to the mother in a cot "separated". The babies were studied during the first 90 min after birth. Axillary and skin temperatures were significantly higher in the skin-to-skin group; at 90 min after birth blood glucose was also significantly higher and the return towards zero of the negative base-excess was more rapid as compared to the "separated" group. Babies kept in cots cried significantly more than those kept skin-to-skin with the mother. Keeping the baby skin-to-skin with the mother preserves energy and accelerates metabolic adaptation and may increase the well-being of the newborn.