Ear acupuncture or local anaesthetics as pain relief during postpartum surgical repair: a randomised controlled trial.

OBJECTIVE: To evaluate two methods of pain relief during postpartum surgical repair in regard to effectiveness, wound healing and patient evaluation. DESIGN: A randomised controlled trial testing a pragmatic set-up of brief training of clinicians. SETTING: Delivery ward at a Danish district hospital with approximately 1600 annual deliveries. POPULATION: Primiparous women with a vaginal delivery at term who needed surgical repair of lacerations to the labia or the vagina, perineal lacerations of first or second degree or mediolateral episiotomies. METHODS: The trial was set up to evaluate the effect of a brief 2-hour hands-on training in the use of ear acupuncture. All midwives (n = 36) in the department had previous experience in using acupuncture for obstetric pain relief. Pain and wound healing were evaluated using validated scores. Data collection was performed by research assistants blinded towards treatment allocation. Randomisation was computer assisted. A total of 207 women were randomised to receive ear acupuncture (105) and local anaesthetics (102), respectively. MAIN OUTCOME MEASURES: The primary outcome was pain during surgical repair. Secondary outcomes were wound healing at 24-48 hours and 14 days postpartum, participant satisfaction, revision of wound or dyspareunia reported 6 months postpartum. RESULTS: Pain during surgical repair was more frequently reported by participants allocated to ear acupuncture compared with participants receiving local anaesthetics (89 versus 54%, P < 0.01). Pain intensity during surgical repair was also reported higher (Visual Analogue Scale score 3.5 versus 1.5, P < 0.01). The ear acupuncture group received more additional pain relief during repair (53 versus 19%, P < 0.01). No difference was observed in wound healing at 24-48 hours or 14 days postpartum. Revision of wounds was rare, and no difference occurred in this trial. Comparable proportions of participants reported dyspareunia at 6 months. Patient satisfaction with the allocated pain-relief method was lower in the ear acupuncture group (69 versus 91%, P < 0.01) and fewer women would recommend the method to a friend (74 versus 91%, P < 0.01). CONCLUSIONS: Ear acupuncture as used in this trial was less effective for pain relief compared with a local anaesthetic. No difference was observed in wound healing, need for revision of wound or dyspareunia. Patient satisfaction with allocated pain-relief method was lower in the ear acupuncture group.

Postpartum perineal repair performed by midwives: a randomised trial comparing two suture techniques leaving the skin unsutured.

OBJECTIVE: To compare a continuous suture technique with interrupted stitches using inverted knots for postpartum perineal repair of second-degree lacerations and episiotomies. DESIGN: A double-blind randomised controlled trial. SETTING: A Danish university hospital with more than 4800 deliveries annually. POPULATION: A total of 400 healthy primiparous women with a vaginal delivery at term. METHOD Randomisation was computer-controlled. Structured interviews and systematic assessment of perineal healing were performed by research midwives blinded to treatment allocation at 24-48 hours, 10 days and 6 months postpartum. Pain was evaluated using a visual analogue scale and the McGill Pain Questionnaire. Wound healing was evaluated using the REEDA scale and by assessment of gaping wounds >0.5 cm. Analysis complied with the intention-to-treat principle. MAIN OUTCOME MEASURES: The primary outcome was perineal pain 10 days after delivery. Secondary outcomes were wound healing, patient satisfaction, dyspareunia, need for resuturing, time elapsed during repair and amount of suture material used. RESULTS: A total of 400 women were randomised; 5 women withdrew their consent, leaving 395 for follow up. The follow-up rate was 98% for all assessments after delivery. No difference was seen in perineal pain 10 days after delivery. No difference was seen in wound healing, patient satisfaction, dyspareunia or need for resuturing. The continuous suture technique was significantly faster (15 versus 17 minutes, P = 0.03) and less suture material was used (one versus two packets, P < 0.01). CONCLUSION: Interrupted, inverted stitches for perineal repair leaving the skin unsutured appear to be equivalent to the continuous suture technique in relation to perineal pain, wound healing, patient satisfaction, dyspareunia and need for resuturing. The continuous technique, however, is faster and requires less suture material, thus leaving it the more cost-effective of the two techniques evaluated.

A longitudinal study of serum cobalamins and its binding proteins in lactating women.

OBJECTIVE: To examine longitudinal changes in serum cobalamins, transcobalamin (TC) and haptocorrin (HC) during lactation and to investigate the influence of vitamin B12 supplementation on these parameters. DESIGN: A 9-month follow-up study. SUBJECTS AND METHODS: Lactating mothers (N=89) including 23 supplemented with vitamin B12 (1-18 microg/daily), 41 partly supplemented and 25 not supplemented. Blood samples collected 3 weeks (baseline) and 4 and 9 months post-partum were analysed for cobalamins, TC and HC. Both the total concentration and the cobalamin-saturated form (holo) of TC and HC were analysed. RESULTS: No significant differences were observed in serum cobalamins or its binding proteins related to supplementation with vitamin B12 or the duration of lactation. Serum cobalamins remained unchanged from 3 weeks to 9 months post-partum. Total TC (holoTC) (median+/-s.e. pmol/l) decreased between 3 weeks (710+/-23 (85+/-12)) and 9 months (602+/-21 (76+/-11)) (P<0.0001 (P=0.0002)), whereas total HC (holoHC) increased from (422+/-11 (300+/-9)) at 4 months to (455+/-13 (317+/-10)) to 9 months post-partum (P<0.0001 (P<0.0001)). CONCLUSION: We report a decrease in TC and an increase in HC during a 9-month period post-partum. No differences were observed between the vitamin B12-supplemented and the unsupplemented groups. Thus, supplementation with vitamin B12 has no impact on the circulating level of serum cobalamins or its binding proteins in a Danish population of lactating mothers.

Postpartum vitamin D insufficiency and secondary hyperparathyroidism in healthy Danish women.

OBJECTIVE: To examine vitamin D status and parathyroid function in normal Danish women postpartum. DESIGN: Three cross-sectional measures during follow-up of 89 women postpartum. SUBJECTS AND INTERVENTION: We assessed vitamin D status by measuring plasma 25-hydroxyvitamin D (P-25OHD) and the degree of secondary hyperparathyroidism by measuring plasma parathyroid hormone (P-PTH) in 89 Caucasian women at three consecutive visits: (mean (range)) 23 (10-37) days (spring), 117 (95-140) days (late summer) and 274 (254-323) days (winter) postpartum. RESULTS: P-25OHD showed seasonal variations with higher values in late summer than in the other periods (P < 0.001). At the first visit, 65% received vitamin D supplements. At the following visits, almost 50% were supplemented. Vitamin D insufficiency (P-25OHD < 50 nmol/l) occurred more often during winter (28%) than in spring (14%) (Fisher's exact test, P = 0.02) or late summer (7%) (P = 0.0001). Irrespective of season, vitamin D insufficiency occurred most frequent in women who did not take vitamin D supplements (Fisher's exact test, P < 0.02). Frank vitamin D deficiency (P-25OHD < 25 nmol/l) was observed during winter in 6%. At all three periods, P-25OHD correlated inversely with P-PTH indicating secondary hyperparathyroidism at deficient vitamin D status. During spring, late summer and winter three, one and four females, respectively, had elevated plasma PTH. CONCLUSION: Vitamin D insufficiency with secondary hyperparathyroidism is a frequent finding in healthy Danish women postpartum and especially during winter. Vitamin D supplements reduced the risk of vitamin D insufficiency, especially during winter. Our results support the importance of increased alertness regarding information of pregnant and lactating women about vitamin D supplements. Furthermore, it has to be studied whether the present recommendations of an intake of 5-10 microg vitamin D/day are sufficient, especially during winter months.

Folate and vitamin B12 in relation to lactation: a 9-month postpartum follow-up study.

OBJECTIVE: To investigate the relation between lactation and markers of folate and vitamin B12 (B12) deficiency in women with and without vitamin supplementation. DESIGN: A 9-month follow-up study. SUBJECTS AND METHODS: Blood samples from 91 women, who gave birth to a single healthy child, were collected 3 weeks, 4 and 9 months postpartum and analysed for circulating level of homocysteine (tHcy), methylmalonic acid (MMA), folate and B12. The participants were categorized as exclusively, partly or not breast-feeding dependent on the degree of lactation 4 months postpartum. During follow-up, lifestyle factors were recorded by structured interviews. RESULTS: Among 72 exclusively breast-feeding women, the median (10-90% percentile) tHcy was 5.8 (3.1-8.3) micromol/l 3 weeks postpartum, 6.1 (4.1-10.3) micromol/l 4 months postpartum and 5.3 (3.6-8.7) micromol/I 9 months postpartum. At 9 months postpartum, none of the women breast-fed exclusively. No significant change occurred in the concentration of B12 and folate. Exclusively breast-feeding women without vitamin supplementation had higher median tHcy than supplemented exclusively breast-feeding women 4 and 9 months postpartum (7.0 vs 5.4 micromol/l (P < 0.001) and 5.8 vs 4.5 micromol/l (P = 0.003), respectively). Six women had increased (>15 micromol/l) tHcy; four of these were unsupplemented and exclusively breast-feeding. CONCLUSION: We found no overall indication of depletion of the folate and B12 stores during the lactation period in this population. However, folate-supplemented women had lower tHcy and higher folate levels, suggesting a beneficial effect of supplementation with folate throughout lactation.

A prospective intervention study of stopping smoking in pregnancy in a routine antenatal care setting.

OBJECTIVES: To evaluate the effect of specific education of midwives on stopping smoking in pregnant women and to determine the effect of this programme on pregnancy outcome. DESIGN: A prospective intervention study. SETTING: Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark. POPULATION AND METHODS: A group of midwives (9 out of 54) was taught the effects of smoking during pregnancy and instructed in various methods of educating women to stop smoking. All pregnant women who attended antenatal care from October 1994 to September 1995 were either in the intervention group (n = 527) or the control group (n = 2629). Pregnant women attending the specifically educated midwives were considered to be the intervention group. They were given individual advice about stopping smoking at the first antenatal visit at about 16 weeks of gestation and a leaflet on smoking and pregnancy. RESULTS: At the first antenatal visit at about 16 weeks of gestation, 22% of the pregnant women smoked. Between the first visit and the routine visit at 30 weeks of gestation 51 (2%) stopped smoking and 56 (2%) started smoking. No differences were found between the intervention group and the control group in the rate of stopping smoking, validated by cotinine measurements. Mean birthweight, mean gestational age and the proportion of preterm birth in the two groups were similar. CONCLUSION: Education of midwives and integration of advice about smoking cessation at a low cost in routine antenatal care failed to affect smoking habits among pregnant women.

Methods and consequences of changes in use of episiotomy.

OBJECTIVES: To evaluate the use of feedback by graphical profiles of rates of episiotomy and the impact on clinical practice and perineal state after spontaneous vaginal deliveries assisted by midwives with different attitudes towards episiotomy. DESIGN: Observation period in labour ward followed by feedback to midwives about their own and other midwives' use of episiotomies. The periods before and after the intervention were compared. SUBJECTS: All women (n = 3919) delivering during the two periods who had been assisted by one of 30 midwives; each midwife supervised at least 20 deliveries during each period. MAIN OUTCOME MEASURES: Overall rates of episiotomies and indications, incidence of intact perineums, perineal lacerations, and tears of anal sphincter. RESULTS: The overall rate of episiotomy during the observation period was 37.1% (615). During the second period the rate was 6.6% lower (95% confidence interval 3.6% to 9.6%), corresponding to a relative decrease of 17.8% (10.1% to 24.7%). Higher rates of episiotomy during the observation period were associated with larger reductions in the second period. The decrease could be explained by less use of episiotomy in deliveries with rigid perineum or impending perineal tear. Compared with the observation period, in the second period 3.2% more women (0.3% to 6.3%) had an intact perineum after delivery and 3.4% (0.4% to 6.2%) experienced perineal tears. The overall incidence of tears of the anal sphincter remained unchanged. Women had a slightly reduced incidence of tears of the anal sphincter, however, if they were delivered by midwives who reduced a medium or high initial rate of episiotomy and a tendency towards an increased incidence of tears if they were assisted by midwives who reduced low initial rates (around 20%) of episiotomy. CONCLUSIONS: Changes in the use of episiotomy induced by awareness of clinical practice among midwives seem to increase the incidence of parturients with intact perineum without a concomitant rise in tears of the anal sphincter. To avoid the increase of such tears these changes should probably be restricted to midwives with rates of episiotomies above 30%.

[Fish oil supplementation and duration of pregnancy. A randomized controlled trial]. / Fiskeolietilskud og graviditetsvarighed. En randomiseret kontrolleret undersøgelse.

It was hypothesised from previous observational studies in the Faroes and Denmark that dietary marine n-3 fatty acids would prolong the duration of pregnancy and thereby increase the birth weight, by influencing the production of prostaglandins involved in the process of parturition. Five hundred and thirty-three healthy Danish women were randomly assigned in the 30th week of pregnancy to fish oil (2.7 g n-3 fatty acids (4 1-g capsules Pikasol oil) per day), olive oil (4 1-g capsules per day) or no oil supplementation. The three groups differed in mean gestational age at birth (ANOVA, p = 0.006), with the fish oil group ranking highest and the olive oil group lowest. Babies born to women allocated fish oil had on average 4.0 (95% confidence interval 1.5;6.4) days higher gestational age and 107 (95% confidence interval 1;214) g higher weight at birth than babies born to women allocated olive oil; the difference in gestational age depended on the level of fish intake at enrollment, with a low fish intake enhancing the difference. Fish oil supplementation in the third trimester seems to prolong gestation while allowing continued growth of the foetus; this effect seems to explain the difference between the Faroes and Denmark in pregnancy duration.

Episiotomy and perineal lesions in spontaneous vaginal deliveries.

OBJECTIVE: To evaluate the influence of mediolateral episiotomy on the perineal state after spontaneous, singleton vaginal deliveries with fetus in the occiput anterior position. DESIGN: The study was a population based, observational study. Two approaches were used in the analyses. Initially, we considered the parturients as quasi-randomised to one of three equally sized groups of midwives with different attitudes towards episiotomy. Secondly, we studied the effect of episiotomy on the state of the anal sphincter, controlling for birthweight, parity, and duration of second stage of labour. SUBJECTS: 2188 pregnant women delivering consecutively. MAIN OUTCOME MEASURES: Perineal lacerations and tear of the anal sphincter. RESULTS: Women allocated to the group of midwives with the lowest rate of episiotomy were more likely to have intact perineum after delivery (OR = 1.8 (1.4-2.2)), had a slight tendency towards more perineal lacerations (OR = 1.3 (1.0-1.5)), but no increase risk of having tear of the anal sphincter, compared with the women allocated to the two groups of midwives with higher frequencies of episiotomy. The second approach showed that episiotomy was related to an increased risk of tear of the anal sphincter (OR = 2.3 (1.2-4.6)). However, this relation was not found among the group of parturients delivered by the midwives with the lowest rate of episiotomy (22%). CONCLUSIONS: Our results encourage a conservative approach to the use of mediolateral episiotomy, and in the light of previous findings, it seems reasonable to suggest that episiotomy should ideally be used in about one in five spontaneous vaginal deliveries.

[99mTc]diphosphonate uptake and hemodynamics in experimental arthritis: effect of naproxen in the canine carrageenan injection model.

The impact of naproxen treatment on juxta-articular hemodynamics and bone metabolism in experimental juvenile arthritis was studied in the articular carrageenan injection model. Unilateral gonarthritis was induced for 12 weeks in eight dogs receiving naproxen (dosage, 2 mg/kg) and eight controls. Regional blood flow was assessed by the microsphere method, plasma volume by the distribution space of [125I]fibrinogen, and bone metabolism by the 2-h uptake of [99mTc]diphosphonate ([99mTc]DPD). Synovial effusion was less prominent with naproxen treatment as judged by joint fluid volume and pressure. Naproxen reduced the arthritic capsular hyperemia, almost normalized a severe blood flow increase in patella and both juxta-articular epiphyses, ameliorated an expansion of plasma volume in the patella and the distal femoral epiphysis, and normalized an increased [99mTc]DPD uptake in subchondral femoral bone and the tibial cortex. Significantly increased arteriovenous shunting in the arthritic extremity was unaffected by naproxen. The study suggests that long-term cyclooxygenase inhibition offers protection against hemodynamic and metabolic changes in juxta-articular bone secondary to synovial inflammation.

Randomised controlled trial of effect of fish-oil supplementation on pregnancy duration.

The high birthweights and long duration of pregnancy in the Faroe Islands led us to suggest that a high intake of marine-fat-derived n-3 fatty acids might prolong pregnancy by shifting the balance of production of prostaglandins involved in parturition. We have compared the effects on pregnancy duration, birthweight, and birth length of a fish-oil supplement, a control olive-oil supplement, and no supplementation. 533 healthy Danish women in week 30 of pregnancy were randomly assigned in a ratio of 2/1/1 to fish oil (four 1 g Pikasol capsules [containing 2.7 g n-3 fatty acids] per day), olive oil (four 1 g capsules per day), or no supplement. The three groups differed in mean length of gestation (p = 0.006), which was highest in the fish-oil group and lowest in the olive-oil group; the result was similar when the analysis was restricted to women with an estimate of gestation length based on early ultrasound findings (443 women). Pregnancies in the fish-oil group were on average 4.0 (95% confidence interval 1.5-6.4) days longer than those in the olive-oil group; the difference in birthweight was 107 (1-214) g. The effect of supplementation on length of gestation was influenced by intake of fish and of fish oil: the difference between fish-oil and other groups was increased by a low fish intake at baseline. Fish-oil supplementation in the third trimester seems to prolong pregnancy without detrimental effects on the growth of the fetus or on the course of labour.

Synovitis reduced by inhibition of leukotriene B4. Carrageenan-induced gonarthritis studied in dogs.

The pathophysiologic significance of leukotriene B4 (LTB4) in arthritis was studied in dogs by unilateral intraarticular deposition of 15-hydroxy-eicosatetraenoic acid (15-HETE), an endogenous inhibitor of the formation and the effects of LTB4, in bilateral carrageenan-induced gonarthritis. LTB4 in synovial fluid was selectively inhibited in 15-HETE treated joints, the formation of prostaglandin E2 (PGE2) being largely unaffected. The clinical symptoms, intraarticular pressure, and extractable synovial fluid volume were reduced in treated joints. No effect could be discerned regarding blood flow in the synovial membrane, capsule, or juxta-articular bone as measured by tracer microspheres; and no effect on bone metabolism was found as judged by 99mTc-diphosphonate uptake. Thus, inhibition of LTB4 reduces joint exudation, but does not seem to interfere with changes in juxta-articular hemodynamics or bone metabolism following synovial inflammation.

15-Hydroxy-eicosatetraenoic acid (15-HETE) inhibits carrageenan-induced experimental arthritis and reduces synovial fluid leukotriene B4 (LTB4).

15-Hydroxy-eicosatetraenoic acid (15-HETE), a product of arachidonic acid, has no proinflammatory capacity, but can inhibit the formation and the chemotactic response of neutrophils to leukotriene B4 (LTB4), a potent mediator of inflammation. The purpose of the present study was to determine whether intraarticular administration of 15-HETE in carrageenan-induced acute arthritis might decrease the levels of LTB4 in synovial fluid and modify the arthritis. A bilateral acute knee joint arthritis was established in 7 dogs by intraarticular injections of carrageenan every third day. To the right joints, 15-HETE was administered both concomitantly with the carrageenan injections and continuously via an osmotic pump. In samples of synovial fluid obtained on day 0, 3 and 10 PGE2 and LTB4 were determined using reversed phase high performance liquid chromatography combined with radioimmunoassays and neutrophil chemokinesis. In the presence of 15-HETE the clinical severity of arthritis was significantly reduced and the volume of synovial effusate was decreased on an average by 42%. Furthermore, the relative number of neutrophils in histological sections of synovial tissue was decreased by 58%. Intraarticular caragheenan injections induced LTB4 formation, and maximum levels were obtained on day 3 (279.2 +/- 148.2 pg/joint). PGE2 was also present on day 3, but maximum levels were detected on day 10 (9.5 +/- 4.8 ng/joint). In joints injected with both carragheenan and 15-HETE the levels of LTB4 on days 3 and 10 were inhibited by 90% and 83%, respectively. For PGE2 a small but insignificant decrease was found on both day 3 and on day 10. These results show that LTB4 may be an important mediator of acute arthritis induced by carragheenan in dogs, and that intraarticular administration of 15-HETE can modify this arthritis by inhibiting LTB4 formation.