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.     

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.     

Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial

Study ObjectiveAlthough various treatment options have been proposed for the treatment of labial adhesions, there are currently no clearly outlined limits on the duration of topical therapy, amount of lateral traction to apply, and methods to decrease the recurrence. This clinical trial was undertaken to assess the need for estrogen for treatment of prepubertal labial adhesions.DesignRandomized, double-blinded, controlled trial.SettingPediatric and Adolescent Gynecology Clinic at a children's hospital in a metropolitan area.ParticipantsPrepubertal girls ages 3 months to 12 years with labial adhesions.InterventionsLateral traction with topical estrogen or topical emollient.Main Outcome MeasuresThe primary outcome was resolution of labial adhesions. The secondary outcome was the change in severity of labial adhesions over time between the 2 groups.ResultsForty-three girls were enrolled and 38 (88%) completed the study. The difference in complete resolution between the topical emollient group (19%) and the topical estrogen group (36%) was not statistically significant (P = .21). There was a statistically significant decrease in severity of labial adhesions over time, with the magnitude of improvement favoring the topical estrogen group.ConclusionAlthough labial adhesion severity decreased when treated with lateral traction and topical emollient or topical estrogen, the magnitude of the effect was significantly greater for topical estrogen.     

The Effects of Whirlpool Baths in Labor: A Randomized,Controlled Trial

ABSTRACT: Background : Showers and tubs in labor were not generally used in our center: When three whirlpool baths (Jacuzzis) were ordered as part of our renovations, a randomized, controlled trial was initiated to explore their effects on narcotic and epidural requirements. Methods : This study employed an intent-to-treat design, and the sample size was estimated to account for the fact that some women would be unable to use the tub. The experimental group of 393 women was offered the tub during labor and the control group of 392 women received conventional care. Results : No births occurred in the tub. The tub group required fewer pharmacologic agents than controls (66% vs 59%, p = 0.06), experienced fewer deliveries by forceps and vacuum (p = 0.019), and were more likely to have an intact perineum than the standard-care group (p = 0.019). Labor was longer for the tub group (p = 0.003), who coincidentally were more primiparous and in earlier labor on admission. No differences were noted in the low rates of maternal and newborn signs of infection in women with ruptured membranes. A subset of mothers expressed satisfaction with the tub experience and labor support. The cesarean rate among both groups was lower (8.9%) than our overall rate (16.6%) during the study period. Conclusions : Whirlpool baths in labor have positive effects on analgesia requirements, instrumentation rates, condition of the perineum, and personal satisfaction. Further study of the effects on labor length, pain, influence of labor support, and psychological outcomes is being planned.     

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.     

Abdominal Ice after Laparoscopic Hysterectomy: A Randomized Controlled Trial

Study ObjectiveTo assess the impact of abdominal ice packs on opioid use and pain control after laparoscopic hysterectomyDesignRandomized controlled trial.SettingAcademic tertiary care medical center.PatientsTotal of 142 adult women undergoing laparoscopic (either conventional or robotic) hysterectomy were randomized to control (n = 69) or intervention (n = 73). Exclusion criteria included preoperative opioid use, planned intensive care unit admission or same-day discharge, an incision ≥4 cm, and regional anesthesia use.InterventionsSubjects in the intervention group had a large ice pack placed directly on the lower abdomen before leaving the operating room. The ice pack was maintained continuously for 12 hours postoperation, as desired thereafter until discharge, and continued use encouraged after discharge for up to 48 hours.Measurements and Main ResultsTotal opioids administered postoperatively, while inpatient and after dismissal, were assessed in morphine milligram equivalents. Postoperative pain, as well as analgesia acceptability and side effects, were assessed using validated measures: Brief Pain Inventory and Overall Benefit of Analgesia Score. Median morphine milligram equivalent was lower in the intervention group than the controls from inpatient stay on the floor to completion of opioid use as an outpatient (22.5 vs 26.2) but was not statistically significant (p = .79). There was no significant difference between the groups in Brief Pain Inventory assessment of postoperative pain severity (p = .80) or pain interference (p = .36) or Overall Benefit of Analgesia Score total score (p = .88). Most patients in the intervention group were very satisfied with ice pack use (n = 51, 79.7%) and very likely to recommend it to friends or family (n = 54, 83.1%). There were no adverse events related to ice pack use.ConclusionThere was no significant difference in postoperative opioid use or pain assessment with ice pack use after laparoscopic hysterectomy. However, most of the subjects expressed high satisfaction specific to ice pack use and would recommend its use to others, suggesting potential desirability as adjunct therapy in postoperative pain control.     

A Randomized Controlled Trial of a Smoking Cessation Intervention During Pregnancy

This study was a randomized controlled trial of a smoking cessation intervention for pregnant smokers. Women who reported smoking at their first antenatal visit and satisfied the inclusion criteria were asked to participate in the trial. Analysis was restricted to 393 evaluable women in the control group (received usual antenatal care) and 339 women to the study group (received usual antenatal care plus the intervention). The primary hypotheses were that the intervention would result in a higher proportion of quitters and that the mean birth-weight of babies born to women receiving the intervention would be greater than that of babies born to women in the control group. The outcome measures were smoking status based on self-report combined with a urinary cotinine level of <115 ng/mL, and birth-weight. There was no significant difference in quit rate between women receiving the intervention and women in the control group (11.9% versus 9.8% p=0.41). Babies born to women receiving the intervention were on average 84 g heavier than babies born to controls (p=0.04). The factors that contribute to the lack of a significant increase in smoking cessation in the intervention group and the possible explanation for the changes in birth-weight are discussed.     

Etonogestrel-Releasing Contraceptive Implant for Postpartum Adolescents: A Randomized Controlled Trial

Study Objective

To compare immediate postpartum insertion of the contraceptive implant to placement at the 6-week postpartum visit among adolescent and young women.

Preoperative Gabapentin for Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Study ObjectiveTo evaluate whether a single dose of gabapentin given preoperatively reduces narcotic use 24 hours after minimally invasive hysterectomy (MIH).DesignRandomized controlled trial.SettingSingle academic-affiliated community hospital.PatientsWomen undergoing MIH for benign indications between June 2016 and June 2017.InterventionsSubjects were randomized to receive a preoperative regimen of acetaminophen, celecoxib, and gabapentin versus acetaminophen and celecoxib alone.Measurements and Main ResultsThe primary outcome assessed was the total amount of narcotics used at 24 hours after surgery. Secondary outcomes included adverse effects from gabapentin use, total narcotics used, and pain scores at 2 weeks after surgery.A total of 129 women were randomized and eligible for analysis in the gabapentin study arm (n = 68) or the control arm (n = 61). Demographic characteristics and surgical details were similar between groups. Narcotics used at 24 hours after surgery totaling 168 versus 161 oral morphine milligram equivalents in the gabapentin and control groups, respectively, did not significantly differ between groups (p = .60). Total narcotics used and pain scores at 2 weeks after surgery and the rates of adverse effects from gabapentin were also similar between study arms.ConclusionSingle-dose, preoperative gabapentin for women undergoing benign MIH does not reduce total opioid use 24 hours after surgery.     

Acupuncture as Pain Relief During Delivery: A Randomized Controlled Trial

ABSTRACT: Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain assessed by a visual analogue scale, birth experience and satisfaction with delivery, and pain relief evaluated at 2 months postpartum. Secondary obstetric outcomes were duration of labor, use of oxytocin, mode of delivery, postpartum hemorrhage, Apgar score, and umbilical cord pH value. Analysis complied with the intention‐to‐treat principle. Results: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p < 0.001; acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin. Mean Apgar score at 5 minutes and umbilical cord pH value were significantly higher among infants in the acupuncture group compared with infants in the other groups. Conclusions: Acupuncture reduced the need for pharmacological and invasive methods during delivery. Acupuncture is a good supplement to existing pain relief methods. (BIRTH 36:1 March 2009)     

A Randomized Controlled Trial of Extra-amniotic Ethinyloestradiol for Cervical Ripening in Multiparas

A double-blind randomized controlled trial was carried out to determine if ethinyloestradiol applied extra-amniotically would ripen the unfavourable cervix at term. Twenty five multiparas were given 150 mg ethinyloestradiol gel while 25 multiparas were given gel alone. There was no difference between the ethinyloestradiol and control groups in either mean change of Bishop score or the induction-to-delivery interval.     

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.     

Optimal Dose of Pituitrin in Laparoscopic Uterine Myomectomy: A Double-Blinded,Randomized Controlled Trial

Study ObjectiveTo determine the optimal effective dose of pituitrin in laparoscopic myomectomy for uterine leiomyoma.DesignDouble-blinded, randomized controlled trial.SettingTertiary women's hospital in China.PatientsTotal of 118 patients who underwent laparoscopic myomectomy.InterventionsPatients randomly received 0, 2, 4, or 6 units of pituitrin injected into the myometrium surrounding the myoma.Measurements and Main ResultsRate of satisfactory surgical condition, hemodynamic changes, total surgical time, and blood loss were recorded. The rates of satisfactory surgical conditions were 6.7%, 72.4%, 89.7%, and 93.3% in groups 0U, 2U, 4U, and 6U, respectively; they were higher in groups 2U, 4U, and 6U than those in group 0U, but there were no significant differences among the groups 2U, 4U, and 6U. The blood loss was higher in group 0U than that in groups 2U, 4U, and 6U (p < .01). Pituitrin was associated with a transient decrease in blood pressures and an increase in heart rate in a dose-dependent fashion, with more pronounced changes in groups 4U and 6U, and these groups also required a higher amount of vasoactive drug to correct hemodynamic changes (p < .05).ConclusionTwo units of pituitrin could provide a satisfactory surgical field with minimal hemodynamic changes for laparoscopic uterine myomectomy.     

Effects of Female Relative Support In Labor: A Randomized Controlled Trial

Background: This study was a randomized controlled trial of primigravidas in Botswana to determine the effectiveness of the presence of a female relative as a labor companion on labor outcomes. Methods: One hundred and nine primigravidas in uncomplicated spontaneous labor were randomly distributed into a control group who labored without family members present, and an experimental group who had a female relative with them during labor. Results: Significantly more mothers in the experimental group had a spontaneous vaginal delivery (91% vs 71%), less intrapartum analgesia (53% vs 73%), less oxytocin (13% vs 30%), fewer amniotomies to augment labor (30% vs 54%), fewer vacuum extractions (4% vs 16%), and fewer cesarean sections (6% vs 13%) than in the control group. These differences were all significant at p < 0.05. Epidural analgesia was not used in the hospital at the time of the study. The only analgesics used were intramuscular pethidine or hyoscine N-butylbromide (Buscopan). Conclusions: The presence in labor of a female relative was shown to be associated with fewer interventions and a higher frequency of normal delivery compared with the outcomes of those without family member support. The presence of a female relative as a labor companion is a low-cost, preventative intervention that is consistent with the traditional cultural practices in Botswana. In the light of this and previous studies, all women giving birth in a hospital should be offered the choice of a female relative as a companion to give support during labor.     

Home versus Hospital Breastfeeding Support for Newborns: A Randomized Controlled Trial

ABSTRACT: Background: The advantages of breastfeeding have been well established for both mothers and their infants. Existing research reports equivocal effects of early discharge and postpartum home care on breastfeeding success. The purpose of this study was to compare the effects of breastfeeding support offered in hospital and home settings on breastfeeding outcomes and maternal satisfaction for mothers of term and near‐term newborns who experienced standard or early discharge. Methods: In a randomized controlled trial with prognostic stratification for gestational age, 101 term and 37 near‐term (35–37 weeks’ gestational age) mother‐newborn pairs were randomized to either a standard care group (standard care and standard length of hospitalization) or an experimental group (standard hospital care with early discharge and home support from nurses who were certified lactation consultants). Data collection occurred before randomization, at discharge from hospital, and from 5 to12 days postpartum. Primary outcomes included breastfeeding rates and maternal satisfaction. Results: More mothers of term newborns in the experimental group were breastfeeding exclusively at follow‐up (p=0.02) compared with the control group. No significant breastfeeding differences occurred among mothers with near‐term newborns in the experimental and standard care groups. Conclusions: In‐home lactation support appears to facilitate positive breastfeeding outcomes for mothers of term newborns. This may also be a beneficial model of postpartum care for mothers of near‐term newborns; however, further research is required. The findings suggest implications for health caregivers and policy makers with respect to postpartum lactation and health care services. (BIRTH 29:4 December 2002)