Wrist-ankle acupuncture as perineal pain relief after mediolateral episiotomy: a pilot study.

OBJECTIVES: The purpose of this pilot study was to evaluate the efficacy of acupuncture in relieving perineal pain after mediolateral episiotomy during childbirth. DESIGN AND SUBJECTS: Women with mediolateral episiotomy during delivery were enrolled in this study and were assigned to be treated or not with acupuncture. OUTCOMES MEASURES: Perineal pain relieving effect of acupuncture was evaluated considering oral analgesics request during post-partum period and was the main outcome of this trial. RESULTS: A total of 42 women were enrolled in this trial. Twenty-one (21) women were treated with "wrist-ankle" acupuncture, inserting one needle in their right ankle. A second group of 21 women was not treated with acupuncture. Women in the acupuncture group were significantly less likely to experience pain; only 8 of them (38.1%) asked for analgesics. All women in the second group assumed oral analgesics because of perineal pain (p < 0.01). CONCLUSIONS: Wrist-ankle acupuncture during the postpartum period is effective for perineal pain relief after mediolateral episiotomy.

Clinical research in traditional medicine: priorities and methods.

This paper explores the challenges and opportunities associated with the evaluation of treatments arising from traditional medical systems (TMS). Globalization and popular consumer-and industry-driven market forces contribute to the spread of traditional treatments, techniques and technologies, but do not necessarily ensure their usefulness or safety. The international scientific community is obliged to evaluate the safety and efficacy of these treatments because of their potential impact on global public health. Clinical evaluations of traditional treatments, however, have complex methodological and practical challenges, depending on the goals of the research and the audience for the results (country of origin; or new host countries and new patient populations). To address these challenges, the authors offer the following recommendations to identify and prioritize treatments to study and how to design study protocols. Evaluations of traditional treatments are best addressed first by collaborative, international, pragmatic studies. Protocols for observational, prospective, pragmatic pilot study (randomized and controlled, when feasible) should be designed collaboratively and executed simultaneously in the culture of origin and in new contexts. This, in turn, could determine the acceptability, usefulness and feasibility of larger randomized controlled trials (RCTs). International multicentre RCTs would have the potential benefits of evaluating safety and effectiveness and also assessing the transferability of a traditional treatment across social and cultural contexts.

Induction of labor: comparison of a cohort with uterine scar from previous cesarean section vs. a cohort with intact uterus.

OBJECTIVE: To compare the risk of uterine rupture between a cohort of women with previous low-transverse cesarean section (CS) and a cohort with intact uterus. METHODS: All women with a singleton pregnancy and previous low-transverse CS requiring induction of labor from January 1, 1992 to December 30, 2001 (n = 310) were compared with a cohort of women with intact uterus undergoing induction of labor during the same study period (n = 5420). Protocols of induction using prostaglandin E2 gel and oxytocin infusion were consistent within groups, but differed between the previous CS and the intact uterus group. RESULTS: Uterine rupture occurred in 0.3% in the previous CS group vs. 0.03% in the intact uterus group (p = 0.37). Logistic regression analysis showed no significant difference in rate of uterine rupture between the previous CS vs. intact uterus group (p = 0.16) after controlling for maternal age, parity, gestational age at delivery, Bishop score on admission, use of prostaglandin and oxytocin, and birth weight. Our study had adequate power to detect a 0.38% difference in rate of uterine rupture between the two groups (alpha = 0.05, beta = 0.80). CONCLUSION: Induction of labor is not associated with significantly higher rates of uterine rupture among women with previous low-transverse CS compared with women with intact uterus provided a consistent protocol with strict intervention criteria is adopted.

A randomised controlled trial of moxibustion for breech presentation.

OBJECTIVES: To evaluate the efficacy of moxibustion for the correction of fetal breech presentation in a non-Chinese population. DESIGN: Single-blind randomised controlled trial (RCT). SETTING: Six obstetric departments in Italy. SAMPLE: Healthy non-Chinese nulliparous pregnant women at 32-33 weeks + 3 days of gestational age with the fetus in breech presentation. METHODS: Random assignment to treatment or observation. Treatment consisted of moxibustion (stimulation with heat from a stick of Artemisia vulgaris) at the BL 67 acupuncture point (Zhiyin) for one or two weeks. Two weeks after recruitment, each participant was subjected to an ultrasonic examination of the fetal presentation. MAIN OUTCOME MEASURE: Number of participants with cephalic presentation in the 35th week. RESULTS: The study was interrupted when 123 participants had been recruited (46% of the planned sample). Intermediate data monitoring revealed a high number of treatment interruptions. At this point no difference was found in cephalic presentation in the 35th week (treatment group: 22/65, 34%; control group: 21/58, 36%; RR 0.95; 99% CI 0.59-1.5). CONCLUSIONS: The results underline the methodological problems evaluating of a traditional treatment transferred from a different cultural context. They do not support either the effectiveness or the ineffectiveness of moxibustion in correcting fetal breech presentation.

Prognostic value of change in amniotic fluid color during labor.

OBJECTIVE: Evidence of meconium-stained amniotic fluid (AF) during labor suggests implementation of close monitoring of fetal well-being. We have investigated whether the presence of meconium in the AF on admission for labor is as important a predictor of neonatal outcome as a change in AF color during labor. METHODS: AF characteristics on admission for labor at term (37-42 weeks) and their changes during labor were recorded in all singleton pregnancies during an 8-year period (1992-1999). Excluded were stillbirths on admission, congenital anomalies, and elective cesarean sections. The presence of meconium and its consistency (light or thick) were documented on admission by inspection with transcervical amnioscopy in women with intact membranes or in the vaginal pool in those with ruptured membranes. Changes in AF color or consistency during labor were recorded and correlated with the obstetric and neonatal outcome. Statistical analysis utilized chi(2) for trend, with p < 0.05 considered significant. RESULTS: 19,090 women were admitted in labor at term during the study period and fulfilled the study inclusion criteria and had amniotic fluid evaluation available. The appearance of meconium or worsening in thickness of meconium during labor was associated with higher rates of Apgar scores <7 at 5 min (clear AF on admission and at delivery 0.6%; light or thick meconium on admission and no change at delivery 0.8%; clear AF on admission and light or thick meconium at delivery 3.2%, and light meconium on admission and thick meconium at delivery 2.5%; p < 0.001) and umbilical artery pH <7.10 (the respective rates in the four groups were 1.7, 1.8, 3.6, and 3.8%; p < 0.001). CONCLUSION: The appearance or thickening of meconium during labor has a greater predictive ability for depressed neonates than the presence of meconium on admission.

Vitamin K acupuncture pint injection for severe primary dysmenorrhea: an international pilot study.

CONTEXT: Vitamin K acupuncture point injection, a menstrual pain treatment derived from traditional Chinese medicine, has been a standard treatment in some hospitals in China since the 1980s. OBJECTIVES: To investigate the effects of vitamin K acupuncture point injection on menstrual pain in young women aged 14 to 25 from different countries and cultural backgrounds who have had unmitigated severe primary dysmenorrhea for 6 months or more. DESIGN: Prospective, observational, clinical pilot study SETTINGS: One site in China (a hospital outpatient clinic in Shanghai) and 2 sites in Italy (a hospital clinic in Milan and a private gynecology practice in Verona). INTERVENTIONS: All subjects were treated with bilateral acupuncture point injection of vitamin K on the first or second day of menstrual pain. Vitamin K3 was used in China and vitamin K4 in Italy. MAIN OUTCOME MEASURES: Pain intensity, total duration, and average intensity of menstrual distress, hours in bed, normal daily activity restrictions, and numbers of analgesic tablets taken to relieve pain were recorded before the treatment and for 4 subsequent menstrual cycles. RESULTS: Noticeable pain relief was observed 2 minutes after treatment, and subsequent pain reduction occurred at 30 minutes (P < .001). Subjects reported significantly fewer daily life restrictions, fewer hours in bed, less consumption of analgesic tablets, and lower scores of menstrual pain duration and intensity (P < .001). There were no adverse events. Some women experienced mild, self-limited pain at the injection site. CONCLUSION: Acupuncture point injection with vitamin K alleviated acute menstrual pain, and relief extended through the nontreatment follow-up cycles in this uncontrolled pilot study conducted in 2 countries. Further investigation employing controlled experimental designs is warranted.

Risks of induction of labour in women with a uterine scar from previous low transverse caesarean section.

OBJECTIVE: Recent studies have shown that among women with uterine scars from previous caesarean section of any type, induction of labour is associated with increased risk of uterine rupture compared with spontaneous labour. We have assessed the risk of uterine rupture in a cohort of women with a previous low transverse caesarean section in whom induction and management of labour were performed according to a strict protocol. DESIGN: Cohort study. SETTING: University Hospital. POPULATION: All women with a singleton pregnancy and a previous low transverse caesarean section requiring induction of labour from 1/1/1992 to 12/30/2001 (n = 310) were compared with a control cohort during the same study period constituted of women with a previous low transverse caesarean section in spontaneous labour (n = 1011). METHODS: Clinical characteristics and rate of uterine rupture of women with previous caesarean section undergoing induction of labour were compared with those of women with previous caesarean section in spontaneous labour. MAIN OUTCOME MEASURE: Incidence of uterine rupture. RESULTS: Uterine rupture occurred in 0.3% in the previous caesarean section--induction group versus 0.3% in the previous caesarean section--spontaneous labour group (P = 0.9). Logistic regression analysis showed no significant difference in the rate of uterine rupture between the induction and spontaneous labour group (P = 0.67) after controlling for maternal age, parity, duration of labour, gestational age at delivery and birthweight. CONCLUSION: Among women with a previous low transverse caesarean section, induction of labour is not associated with significantly higher rates of uterine rupture compared with spontaneous labour, provided a consistent protocol with strict criteria for intervention is adopted.