Team Midwifery Care in a Tertiary Level Obstetric Service: A Randomized Controlled Trial

Background: In 1996 a new model of maternity care characterized by continuity of midwifery care from early pregnancy through to the postpartum period was implemented for women attending Monash Medical Centre, a tertiary level obstetric service, in Melbourne, Australia. The objective of this study was to compare the new model of care with standard maternity care. Methods: In a randomized controlled trial, 1000 women who booked at the antenatal clinic and met the eligibility criteria were randomly allocated to receive continuity of midwifery care (team care) from a group of seven midwives in collaboration with obstetric staff, or care from a variety of midwives and obstetric staff (standard care). The primary outcome measures were procedures in labor, maternal outcomes, neonatal outcomes, and length of hospital stay. Results: Women assigned to the team care group experienced less augmentation of labor, less electronic fetal monitoring, less use of narcotic and epidural analgesia, and fewer episiotomies but more unsutured tears. Team care women stayed in hospital 7 hours less than women in standard care. More babies of standard care mothers were admitted to the special care nurseries for more than 5 days because of preterm birth, and more babies of team care mothers were admitted to the nurseries for more than 5 days with intrauterine growth retardation. No differences occurred in perinatal mortality between the two groups. Conclusions: Continuity of midwifery care was associated with a reduction in medical procedures in labor and a shorter length of stay without compromising maternal and perinatal safety. Continuity of midwifery care is realistically achievable in a tertiary obstetric referral service.     

Patient Safety in Midwifery Care for Low‐Risk Women: Instrument Development

Introduction: Few studies have examined the safety of midwife‐led care for low‐risk childbearing women. While most women have a low‐risk profile at the start of pregnancy, validated measures to detect patient safety risks for this population are needed. The increased interest of midwife‐led care for childbearing women to substitute for other models of care requires careful evaluation of safety aspects. In this study, we developed and tested an instrument for safety assessment of midwifery care. Methods: A structured approach was followed for instrument development. First, we reviewed the literature on patient safety in general and obstetric and midwifery care in particular. We identified 5 domains of patient risk: organization, communication, patient‐related risk factors, clinical management, and outcomes. We then developed a prototype to assess patient records and, in an iterative process, reviewed the prototype with the help of a review team of midwives and safety experts. The instrument was pilot tested for content validity, reliability, and feasibility. Results: Trained reviewers with clinical midwifery expertise applied the instrument. We were able to reduce the original 100‐item screening instrument to 32 items and applied the instrument to patient records in a reliable manner. With regard to the validity of the instrument, review of the literature and the validation procedure produced good content validity. Discussion: A valid and feasible instrument to assess patient safety in low‐risk childbearing women is now available and can be used for quantitative analyses of patient records and to identify unsafe situations. Identification and analysis of patient safety incidents required clinical judgment and consultation with the panel of safety experts. The instrument allows us to draw conclusions about safety and to recommend steps for specific, domain‐based improvements. Studies on the use of the instrument for improving patient safety are recommended.     

Maternal Satisfaction with Active Management of Labor: A Randomized Controlled Trial

Background: Active management of labor reduces the length of labor and rate of prolonged labor, but its effect on satisfaction with care, within a randomized controlled trial, has not previously been reported. The study objectives were to establish if a policy of active management of labor affected any aspect of maternal satisfaction, and to determine the independent explanatory variables for satisfaction with labor care in a low‐risk nulliparous obstetric population. Methods: Nulliparous women at National Women's Hospital in Auckland, New Zealand, in spontaneous labor at term with singleton pregnancy, cephalic presentation, and without fetal distress were randomized after the onset of labor to active management (n= 320) or routine care (n= 331). Active management included early amniotomy, two‐hourly vaginal assessments, and early use of high dose oxytocin for slow progress in labor. Routine care was not prespecified. Maternal satisfaction with labor care was assessed by postal questionnaire at 6 weeks postpartum. Sensitivity analyses were performed, and logistic regression models were developed to determine independent explanatory variables for satisfaction. Results: Of the 651 women randomized in the trial, 482 (74%) returned the questionnaires. Satisfaction with labor care was high (77%) and did not significantly differ by treatment group. This finding was stable when sensitivity analysis was performed. The first logistic regression model found independent associations between satisfaction and adequate pain relief, one‐to‐one midwifery care, adequate information and explanations by staff, accurate expectation of length of labor, not having a postpartum hemorrhage, and fewer than three vaginal examinations during labor. The second model found fewer than three vaginal examinations and one‐to‐one midwifery care as significant explanatory variables for satisfaction with labor care. Conclusions: Active management did not adversely affect women's satisfaction with labor and delivery care in this trial. Future studies should concentrate on measurement of potential predictors before and during labor.     

Women's Satisfaction with Birth Center Care: A Randomized,Controlled Study

This randomized, controlled trial compared women's satisfaction with care at an in-hospital birth center with standard obstetric care in Stockholm. Subjects were 1230 women with an expected date of birth between October 1989 and February 1992, who expressed interest in birth center care, and who were medically low risk. The intervention was the random allocation of maternity care at the birth center or standard obstetric care. Birth center women expressed greater satisfaction with antenatal, intrapartum, and postpartum care, especially psychological aspects of care. Of these women, 63 percent thought that the antenatal care had raised their self-esteem, versus 18 percent of the control group. Eighty-nine percent of the experimental group would prefer birth center care for any future birth, and 46 percent of the control group would prefer standard care. Birth center care successfully meets the needs of women who are interested in natural childbirth and active involvement in their own care, and are concerned about the psychological aspects of birth.     

A Randomized,Controlled Trial of Nurse-Midwifery Care

ABSTRACT: Background : In 1990 a pilot nurse-midwifery program was implemented in a tertiary care hospital in a major western Canadian city. A randomized, controlled trial was conducted to determine if when maternal and newborn patient outcomes were compared, the midwifery program was as effective as traditional, low-risk health care available in the city. Methods : All low-risk women who requested and qualified for nurse-midwifery care were randomly assigned to an experimental or control group. Results : One hundred one women received care from nurse-midwives and 93 received standard care from either an obstetrician or family physician. The rate of cesarean delivery in the nurse-midwife group was 4 percent compared with 15.1 percent in the physician group. The episiotomy rate, excluding cesarean deliveries, for the nurse-midwife group was 15.5percent compared with 32.9 percent in the physician group. The rates of epidural anesthesia for pain relief in labor were 12.9 percent and 23.7 percent, respectively. Statistically significant differences were found for ultrasound examinations, amniotomy, intravenous drug administration during labor; dietary supplements, length of hospital stay, and admission of infants to the neonatal intensive care unit. Conclusions : The results clearly support the effectiveness of the pilot nurse-midwifery program and suggest that more extensive participation of midwives in the Canadian health care system is an appropriate use of health care dollars.     

Women's Satisfaction with Their Involvement in Health Care Decisions During a High‐Risk Pregnancy

ABSTRACT: Background: Increasingly, women seek involvement in decisions about their health care. The purpose of this study was to examine women's experience of, and satisfaction with, their involvement in health care decisions during a high‐risk pregnancy. Methods: Forty‐seven women with hypertension or threatened preterm delivery (including multiple births) were interviewed after the birth of their child. They received prenatal care at home from nurses in a community program or were hospitalized. The in‐depth interviews were audiotaped and transcribed; data were analyzed using constant comparative methods. Results: Women identified an increased feeling of responsibility for the health of their baby and themselves, but differed in choosing active or passive involvement in health care decisions. Women who wanted active involvement achieved it through one of three processes: struggling for, negotiating, or being encouraged. Women who wanted passive involvement and women facing health crises used the process of trusting in the expertise of nurses and physicians. Women were satisfied if the care from health care professionals was congruent with how they wanted to be involved in decision‐making. Conclusions: Although most women want to be actively involved in health decision‐making during a high‐risk pregnancy, some prefer a passive role. The setting of prenatal care, community‐based or in‐hospital, was less important than the ability of nurses and physicians to support the woman in her preferred role in decision‐making. (BIRTH 30:2 June 2003)     

Effects of Yoga on Sexual Function in Women with Metabolic Syndrome: A Randomized Controlled Trial

IntroductionFemale sexual dysfunction is an important public health issue; it has a high global prevalence, but no effective and safe treatment options. The prevalence of sexual dysfunction is higher in women with metabolic syndrome than in the general population.AimThe aim of this study was to investigate the efficacy of yoga as a treatment for sexual dysfunction in women with metabolic syndrome.MethodsIn this randomized, controlled study, 41 women with metabolic syndrome (age 30–60 years) were assigned to a 12-week yoga exercise group (n = 20) or a wait-listed control group (n = 21).Main Outcome MeasuresPrimary end points were changes in total and individual domain scores on the Female Sexual Function Index.ResultsThe 12-week yoga intervention resulted in significant improvement in arousal (0.74 ± 1.18 vs. 0.16 ± 0.82, respectively; P = 0.042) and lubrication (0.72 ± 1.12 vs. 0.06 ± 0.87, respectively; P = 0.008) compared with the control group. Systolic blood pressure showed significantly greater improvement in the yoga group than in the control group at the 12-week follow up (?3.5 ± 13.7 vs. 2.0 ± 14.7, respectively; P = 0.040).ConclusionThese findings suggest that yoga may be an effective treatment for sexual dysfunction in women with metabolic syndrome as well as for metabolic risk factors. Kim H-N, Ryu J, Kim K-S, and Song S-W. Effects of yoga on sexual function in women with metabolic syndrome: A randomized controlled trial. J Sex Med 2013;10:2741–2751.     

Pregnancy and Childbirth Care Following Conflict and Displacement: Care for Refugee Women in Low‐Resource Settings

Women in developing countries experience the same problems during pregnancy and childbirth and die of the same complications, regardless of whether they live in stable situations or in situations of conflict and displacement. They need services and/or care during pregnancy and childbirth wherever they are and in whatever circumstances prevail. This article provides an overview of the Safe Motherhood Initiative, including the recent directions taken to prevent maternal and neonatal mortality and morbidity. In addition, pregnancy and childbirth care in complex humanitarian emergencies is examined, highlighting the experiences in refugee settings. In some of these settings, pregnancy outcomes have been better than in host or home countries. The challenge remains to ensure that good‐quality pregnancy and childbirth care, in line with the global standards set for achieving safe motherhood, is consistently available and accessible to women affected by complex humanitarian emergencies.     

Music Therapy for Preoperative Anxiety Reduction in Women Undergoing Total Laparoscopic Hysterectomy: A Randomized Controlled Trial

Study ObjectiveTo assess the superiority of a music therapy intervention (Music) vs usual care (Control) in reducing the preoperative anxiety of patients undergoing total laparoscopic hysterectomy (TLH) with nononcologic indications.DesignThis was a 1:2 (Music vs Control) randomized controlled study.SettingA teaching hospital.PatientsOne hundred patients were available for the analysis: 30 and 70 in the Music and Control arms, respectively.InterventionsPerioperative music therapy pathway in patients undergoing TLH for benign disease.Measurements and Main ResultsAnxiety was evaluated with the State-Trait Anxiety Inventory Y Form (STAI-Y) at different time points: at baseline and during preoperative, early postoperative, and late postoperative periods. Pathologic anxiety was defined as STAI-Y state >45. Postoperative pain was registered using the visual analog scale.Women in the Music arm experienced lower anxiety levels (median STAI-Y scores 38.0 vs 41.0; p = .002) during the preoperative period. STAI-Y scores did not vary significantly by intervention at each subsequent time point. A significant difference between the groups (Music vs Control) was found in the proportion of women with pathologic anxiety during the preoperative (16.7% vs 37.2%; p = .04) and early postoperative periods (0% vs 12.9%; p = .04), whereas no significant difference between the groups was registered during the late postoperative period (6.6% vs 7.1%; p = .93). Postoperative pain intensity did not significantly differ between the groups at 1, 3, and 6 hours after surgery.ConclusionsMusic therapy might be a viable complementary modality to usual surgical care in the gynecologic setting for its ability to significantly decrease preoperative anxiety in women undergoing TLH for benign conditions.     

Anti-Androgenic Effects Comparison Between Cyproterone Acetate and Spironolactone in Transgender Women: A Randomized Controlled Trial

BackgroundSpironolactone and cyproterone acetate are commonly used in feminizing hormone therapy to achieve the goal of female range testosterone level; however, the data on the efficacy comparing between these two anti-androgens are scarce.AimTo compare the anti-androgenic effects between spironolactone and cyproterone acetate as the component of feminizing hormone therapy among transgender women population.MethodsThe study was single-blinded randomized controlled trial involved 52 transgender women from two transgender health clinics. Each participant received oral estradiol valerate 4 mg/day combined with anti-androgen, spironolactone 100 mg/day or cyproterone acetate 25 mg/day, depending on which group they were randomized to. Clinical and biochemical variables were obtained at baseline and at 12 weeks of feminizing hormone therapy.Main Outcome MeasuresThe change of testosterone level from baseline. Other changes including free testosterone, estradiol, prolactin and lipid profile after the therapy.ResultsAfter a 12 weeks of feminizing hormone therapy, the change of testosterone level in the cyproterone acetate group [558.0 ng/dL (IQR 352.0 to 783.3)] was significantly higher than the spironolactone group [226.2 ng/dL (IQR,-4.3 to 480.1)](p value <0.001). Testosterone and calculated free testosterone in the cyproterone acetate group were significantly lower than the spironolactone group. Consequently, a proportion of the participants who achieved the female range testosterone (<50 ng/dL) was significantly higher in cyproterone acetate group (90%) compared to the spironolactone group (19%). Serious adverse effects observed in cyproterone acetate users were drug-induced liver injury and asymptomatic hyperprolactinemia.Clinical ImplicationsThe data on the differences between the two anti-androgen could be benefit for the transgender health-care providers in medication selection and adverse-effects counseling.Strengths & LimitationsThe study design was randomized controlled trial and controlled the estrogen component by prescribed the same type and dose for each participant. However, the study was suffered from the confound feminizing effects from previous hormone therapy and the high drop-out rate.ConclusionFor feminizing hormone therapy, cyproterone acetate had a higher testosterone suppression efficacy than spironolactone.Burinkul S, Panyakhamlerd K, Suwan A, et al. Anti-Andorgenic Effects Comparison Between Cyproterone Acetate and Spironolactone in Transgender Women: A Randomized Controlled Trial. J Sex Med 2021;18:1299–1307.     

A Planning Checklist for Interprofessional Consultations for Women in Midwifery Care

Team‐based, interprofessional models of maternity care can allow women to receive personalized care based on their health needs and personal preferences. However, involvement of multiple health care providers can fragment care and increase communication errors, which are a major cause of preventable maternal morbidity and mortality. In order to improve communication within one health system, a community‐engaged approach was used to develop a planning checklist for the care of women who began care with midwives but developed risks for poor perinatal outcomes. The planning checklist was constructed using feedback from women, nurses, midwives, and physicians in one interprofessional, collaborative network. In feasibility testing during 50 collaborative visits, the planning checklist provided a prompt to generate a comprehensive plan for maternity care and elucidate the rationale for interventions to women and future health care providers. In interviews after implementation of the checklist within a new collaborative format of prenatal physician consultations, women were pleased with the information received, and nurses, midwives, and physicians were positive about improved communication. This tool, developed with stakeholder input, was easy to implement and qualitatively beneficial to satisfaction and health system function. This article details the creation, implementation, and qualitative evaluation of the planning checklist. The checklist is provided and can be modified to meet the needs of other health systems.     

Clinical Effectiveness of Transcervical Polyp Resection in Women with Endometrial Polyps: Randomized Controlled Trial

Study ObjectiveTo estimate the clinical effectiveness of transcervical resection of endometrial polyps.DesignRandomized controlled trial (Canadian Task Force classification I).SettingUniversity teaching hospital.PatientsOne hundred fifty premenopausal women with endometrial polyps.InterventionsEither transcervical resection of the polyp or observation for 6 months.Measurements and Main ResultsThere was no difference in periodic blood loss measured using the Pictorial Blood Assessment Chart between the study groups at 6-month follow-up. A significant difference between the groups was observed in favor of the intervention group for 2 secondary outcome measures: mean difference of periodic blood loss measured using a visual analog scale (score, 0.7; 95% confidence interval, 0.11–1.30; p = .02) and occurrence of gynecologic symptoms at follow-up (7 of 75 patients [9.3%] vs 28 of 75 [37.3%]; p <.001). Data were analyzed according to the principle of intention to treat.ConclusionTranscervical resection of endometrial polyps seems to have minimal effect on periodic blood loss; however, the procedure seems to relieve symptoms such as intermenstrual bleeding in most premenopausal women.     

A Randomized Controlled Trial of a Nursery Ritual: Wearing Cover Gowns to Care for Healthy Newborns

ABSTRACT: The routine wearing of individual cover gowns by nurses and visitors for direct care of healthy newborns was usual practice on the maternity ward of a regional referral center. We conducted a randomized trial in which cover gowns were not provided for care of infants in the experimental group (n= 222), but were maintained for control infants (n= 230). The principal outcome measured was Staphylococcus aureus colonization of the newborn nares or umbilicus on day 3 or day of discharge. Twenty percent (n= 51) of the experimental group (no gown) had a positive culture compared with 21 percent (n= 47) of the controls. Of the infants with positive cultures, two in each group exhibited symptoms of overt S. aureus infection. Experimental infants were similar to controls with respect to feeding method, route of delivery, amount of time spent rooming-in, and average number of visitors per day. In the group of positively cultured infants, the mothers experienced longer labor, and more vaginal examinations in labor, and the number of males undergoing circumcision was higher. We concluded that routine use of cover gowns was unwarranted, and we have altered the ward policy accordingly. This also has had a positive economic effect.     

Effects of Guided Imagery on Blood Pressure in Pregnant Women with Hypertension: A Pilot Randomized Controlled Trial

Abstract: Background: Hypertension occurs in nearly 10 percent of pregnancies, and is associated with higher risk of infant and maternal morbidity and mortality than in normal pregnancies. Previous studies have suggested that relaxation therapies reduce blood pressure in nonpregnant adults. The objectives of this pilot randomized trial were to provide preliminary evidence of whether relaxation by means of guided imagery would reduce blood pressure in hypertensive pregnant women, and to assess the feasibility of a larger trial. Methods: A total of 69 pregnant women with hypertension were randomized to periods of guided imagery or of quiet rest, twice daily for 4 weeks or until delivery, whichever came first. Daytime ambulatory mean arterial pressure, systolic and diastolic blood pressure, and anxiety were measured weekly for up to 4 weeks. Results: Women allocated to guided imagery had lower mean arterial pressure elevations over time than those allocated to quiet rest (guided imagery: M = 1.58 mmHg, SD = 7.63; quiet rest: M = 5.93 mmHg, SD = 6.55; t = 2.36, p = 0.02). However, when adjusted for baseline mean arterial pressure and gestation, the effect was not significant (p = 0.14). Numbers of women prescribed antihypertensive medication postrandomization were similar (guided imagery: n = 16; quiet rest: n = 13, χ² = 0.74, p = 0.46). There was also no evidence of an effect on women’s anxiety. Nearly 90 percent (n = 26) of the guided imagery group indicated that they would use it again. Conclusions: Further rigorous study is warranted to determine effects of guided imagery on maternal blood pressure and perinatal health outcomes. (BIRTH 37:4 December 2010)     

Randomized Controlled Trial of Hands‐and‐Knees Positioning for Occipitoposterior Position in Labor

ABSTRACT: Background: Hands‐and‐knees positioning during labor has been recommended on the theory that gravity and buoyancy may promote fetal head rotation to the anterior position and reduce persistent back pain. A Cochrane review found insufficient evidence to support the effectiveness of this intervention during labor. The purpose of this study was to evaluate the effect of maternal hands‐and‐knees positioning on fetal head rotation from occipitoposterior to occipitoanterior position, persistent back pain, and other perinatal outcomes. Methods: Thirteen labor units in university‐affiliated hospitals participated in this multicenter randomized, controlled trial. Study participants were 147 women laboring with a fetus at ≥37 weeks’ gestation and confirmed by ultrasound to be in occipitoposterior position. Seventy women were randomized to the intervention group (hands‐and‐knees positioning for at least 30 minutes over a 1‐hour period during labor) and 77 to the control group (no hands‐and‐knees positioning). The primary outcome was occipitoanterior position determined by ultrasound following the 1‐hour study period and the secondary outcome was persistent back pain. Other outcomes included operative delivery, fetal head position at delivery, perineal trauma, Apgar scores, length of labor, and women's views with respect to positioning. Results: Women randomized to the intervention group had significant reductions in persistent back pain. Eleven women (16%) allocated to use hands‐and‐knees positioning had fetal heads in occipitoanterior position following the 1‐hour study period compared with 5 (7%) in the control group (relative risk 2.4; 95% CI 0.88–6.62; number needed to treat 11). Trends toward benefit for the intervention group were seen for several other outcomes, including operative delivery, fetal head position at delivery, 1‐minute Apgar scores, and time to delivery. Conclusions: Maternal hands‐and‐knees positioning during labor with a fetus in occipitoposterior position reduces persistent back pain and is acceptable to laboring women. Given this evidence, hands‐and‐knees positioning should be offered to women laboring with a fetus in occipitoposterior position in the first stage of labor to reduce persistent back pain. Although this study demonstrates trends toward improved birth outcomes, further trials are needed to determine if hands‐and‐knees positioning promotes fetal head rotation to occipitoanterior and reduces operative delivery. (BIRTH 32:4 December 2005)