Sweeping of the membranes versus uterine stimulation by oxytocin in nulliparous women. A randomized controlled trial

The aim of this study was to evaluate whether sweeping of the membranes at term could shorten the length of pregnancy and reduce the incidence of postterm pregnancies. We randomly selected 104 nulliparas with uncomplicated pregnancy and gestational age between 281 and 287 days. Our patients were divided into three groups. Group A consisted of 34 women who were subjected to sweeping of the membranes. Uterine stimulation with oxytocin was applied in 35 women (group B), and 35 women (group C) were used as a control group. We had no significant reduction of the time interval from sweeping of the membranes until delivery (1.9 +/- 1.2 days), compared to that of group B (2.1 +/- 0.8 days) as well as that of the control group (2.5 +/- 0.9 days). The incidence of spontaneous labor in patients after sweeping of the membranes was greater (67.6%) when compared with oxytocin-stimulated patients and the control group (p < 0.05). Furthermore, a better Bishop score was noted in patients of group A. No statistically significant difference was noted in the mode of delivery between the groups, but sweeping of the membranes significantly decreased the incidence of postterm pregnancies (p < 0. 05). We concluded that sweeping of the membranes is an effective method for initiating labor in women with a gestational age between 40 and 41 weeks, thus reducing the need for induction.     

The effects of acupuncture during labour on nulliparous women: a randomised controlled trial

BACKGROUND: Acupuncture is as an ancient system of diagnosis and treatment. It is regarded as a complementary tool for pain management. AIMS: To assess the effects of acupuncture on nulliparous women during labour with respect to pain, labour duration and maternal acceptability. METHODS: One hundred and forty-four healthy nulliparous women in active phase were randomised into the study and control group, receiving real and minimal acupuncture, respectively. Visual analogue scale was used to assess pain. Objectives were to evaluate acupuncture effect on pain and labour duration and patients' willingness to receive acupuncture for subsequent pregnancies. RESULTS: Visual analogue scale pain score in the study group was lower after two hours. Active phase duration and the oxytocin units administered were lower in the study group. Study group patients had greater willingness to receive acupuncture again. No adverse effects were detected. CONCLUSIONS: Acupuncture could reduce pain experience, active phase duration and oxytocin units. Patients were satisfied and no adverse effects were noted.     

Early versus delayed oxytocin augmentation in nulliparous women with prolonged labour—a randomised controlled trial

Objective  To study the effects of early versus delayed oxytocin augmentation on the obstetrical and neonatal outcome in nulliparous women with spontaneous but prolonged labour.
Design  Randomised controlled study.
Setting  Two delivery units in Sweden.
Population  Healthy nulliparous women with normal pregnancies, spontaneous onset of active labour, a cervical dilatation of 4–9 cm and no progress in cervical dilatation for 2 hours and for an additional hour if amniotomy was performed due to slow progress.
Methods  Women ( n = 630) were randomly allocated either to labour augmentation by oxytocin infusion (early oxytocin group) or to postponement of oxytocin augmentation for another 3 hours (expectant group).
Main outcome measure  Mode of delivery (spontaneous vaginal or instrumental vaginal delivery or caesarean section) and time from randomisation to delivery.
Results  The caesarean section rate was 29 of 314 (9%) in the early oxytocin group and 34 of 316 (11%) in the expectant group (OR 0.8, 95% CI 0.5–1.4), and instrumental vaginal delivery 54 of 314 (17%) in the early oxytocin versus 38 of 316 (12%) in the expectant group (OR 1.5, 95% CI 0.97–2.4). Early initiation of oxytocin resulted in a mean decrease of 85 minutes in the randomisation to delivery interval.
Conclusion  Early administration of oxytocin did not change the rate of caesarean section or instrumental vaginal delivery but shortened labour duration significantly in women with a 2-hour arrest in cervical dilatation. No other clear benefits or harms were seen between early and delayed administration of oxytocin.     

Immediate and delayed pushing in the second stage of labour for nulliparous women with epidural analgesia: a randomised controlled trial

Objective To test the hypothesis that a policy of delaying active pushing in nulliparous women with epidural analgesia in labour reduces operative vaginal deliveries.
Design A randomised controlled trial.
Setting The delivery suite at Leeds General Infirmary.
Sample One hundred and thirty-five nulliparous women with an effective epidural in labour.
Methods The women were randomised to early pushing (commencement of pushing within one hour of the diagnosis of full dilatation) or delayed pushing (delaying pushing for a maximum of three hours from the time of diagnosis of full dilatation, unless the vertex was visible at the introitus sooner). epidural analgesia in labour reduces operative vaginal deliveries.
Main outcome measure Rate of instrumental vaginal delivery.
Results There was a nonsignificantly increased rate of instrumental vaginal delivery with early pushing (odds ratio 1.31,95% CI 0.62–2.78). No adverse effects were noted.
Conclusion Although delayed pushing was associated with fewer instrumental vaginal deliveries, the size of the effect may have occurred by chance and the evidence does not, at present, justify a general recommendation towards either early or delayed pushing.     

Premature rupture of membranes at term in nulliparous women: a hazard?

One hundred five consecutive women with premature rupture of the membranes (PROM) at term were managed expectantly for at least 24 hours. Seventy-six went into spontaneous labor, of whom 38 were augmented with oxytocin. Twenty-nine had labor induced. Subjects who delivered during the same study interval after artificial rupture of the membranes served as controls. There were no statistically significant differences in the frequency of amnionitis, endometritis, cystitis, neonatal infection, low Apgar score, low cord arterial blood pH, instrumental delivery, or cesarean delivery. Morbidity was seen most often in induced labor whether or not the membranes were ruptured for a long time. It is concluded that expectant management of PROM at term does not increase perinatal morbidity.     

Transabdominal amnioinfusion in preterm premature rupture of membranes: a randomised controlled trial

OBJECTIVE: To evaluate the role of transabdominal amnioinfusion in improving the perinatal outcomes of pregnancies complicated by preterm premature rupture of membranes (pPROM). DESIGN: A randomised controlled trial. SETTING: A teaching hospital in Italy, obstetric unit. Population Women with singleton pregnancies complicated by pPROM, between 24 + 0 and 32 + 6 weeks of gestation. METHODS: Patients were randomised 24 hours after admission to our referral hospital, to expectant management with transabdominal amnioinfusion or expectant management only. MAIN OUTCOME MEASURES: The effects of transabdominal amnioinfusion on pPROM-delivery interval and on perinatal outcomes. RESULTS: Of the 65 women with pPROM 34 met the inclusion criteria. Seventeen women were assigned to amnioinfusion (the amnioinfusion group) and the other 17 to expectant management. Compared with the control group (median: 8 days; range: 3-14), the pPROM-delivery period was significantly longer in women who underwent amnioinfusion (median: 21 days; range: 15-29) (P < 0.05). Women with amnioinfusion were less likely to deliver within seven days since pPROM (RR: 0.18; range: 0.04-0.69 95% CI) or within two weeks (RR: 0.46; range: 0.21-1.02 95% CI). In the amnioinfusion group the neonatal survival was significantly higher at each gestational age (P < 0.01, Yates's correction for Log Rank Test) with a reduction in pulmonary hypoplasia. CONCLUSIONS: We demonstrated that compared with standard expectant management the treatment with transabdominal amnioinfusion after pPROM resulted in significant prolongation of pregnancy and better neonatal outcomes.     

A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women

Background  Oxytocin is widely used to speed up slow labour, especially in nulliparous women, but randomised trials, apart from one reported only in abstract, have been too small to exclude important effects.
Objective  To test the hypothesis that early use of oxytocin reduces the need for caesarean delivery.
Design  A randomised controlled trial.
Setting  Twelve obstetric units within the Northern and Yorkshire regions in the North East of England.
Participants  A total of 412 low-risk nulliparous women in spontaneous labour at term, who had been diagnosed with primary dysfunctional labour were recruited from January 1999 to December 2001.
Intervention  Immediate oxytocin administration (active group) or oxytocin withheld for up to 8 hours (conservative group).
Main outcome measures  Caesarean section and operative vaginal delivery rates. The length of labour measured from the time of randomisation to delivery. The rate of maternal Edinburgh Postnatal Depression Scale (EPDS) greater than 12 (major depression) within 48 hours of delivery.
Results  The caesarean section rates were 13.5% active versus 13.7% controls (OR 0.98, 95% CI 0.6–1.7). Operative delivery, 24.5% versus 30.9% (OR 0.73, 95% CI 0.5–1.1). The median (interquartile range) randomisation to delivery interval in the active group was 5 hours 52 minutes (3:57–8:28) and in the conservative group 9 hours 8 minutes (5:06–13:16) ( P < 0.001). The rate of EPDS >12 was 20% in the active arm versus 15% among controls (OR 1.26, 95% CI 0.7–2.2). There was one perinatal death in each group and no major differences in perinatal outcomes.
Conclusions  Among nulliparous women with primary dysfunctional labour, early use of oxytocin does not reduce caesarean section or short-term postnatal depression. However, it shortens labour considerably and may reduce operative vaginal deliveries.     

A randomised trial of two expectant managements of prelabour rupture of the membranes at 34 to 42 weeks

Objective To compare obstetric and perinatal outcome between two different expectant managements in women with prelabour rupture of the membranes (PROM).
Design A randomised study.
Participants One thousand three hundred and eighty-five women with rupture of the membranes at 34 to 42 weeks without contractions.
Interventions Women without contractions 2 h after admission were randomised to early induction the following morning after PROM (early induction group) or induction two days later (late induction group). Women with contractions starting within 2 h after admission were included in the calculations as a short latency group. Digital examinations of the cervix were avoided until onset of active labour. Labour was induced with oxytocin in both groups if no spontaneous contractions occurred or if chorioamnionitis or fetal distress was detected.
Main outcome measures The frequency of spontaneous deliveries, operative deliveries, maternal and neonatal infections.
Results In nulliparous women, a higher rate of spontaneous deliveries was found in the late induction group (89%) compared with the early induction group (81%) (   P < 0.05  ). The ventouse extraction rate was 7% and 14% respectively (   P < 0.05  ). A low (2–4%) caesarean section rate was recorded and did not differ between the groups. Endometritis was detected in six women after delivery. Sixty-one children were treated with antibiotics, and no difference could be detected between the groups.
Conclusions A higher rate of spontaneous deliveries was found among nulliparous women with prolonged latency as compared with brief latency prior to induction. A protocol of no digital examination before labour was associated with infrequent maternal and fetal morbidity, regardless of latency.     

A randomized controlled trial of acupuncture for initiation of labor in nulliparous women

Objective. To evaluate the utility of outpatient acupuncture for labor stimulation.

Methods. Nulliparous women at 39 4/7 weeks or greater with a singleton gestation and Bishop score of less than 7 were randomized to usual medical care (control group) versus usual care and three outpatient acupuncture treatments (acupuncture group). Each treatment consisted of eight needles applied to bilateral points LI4, SP6, UB31, and UB32. The primary outcome was time elapsed from the time of randomization to delivery. Secondary outcomes included rates of cesarean section and induction of labor. Medical records were abstracted for maternal demographic, medical, and delivery outcome data. A priori sample size calculation revealed that 56 women were required to detect a 72-hour difference in delivery time with a power of 83% and an alpha of 0.05. Student's t-test, Chi-square, and Kaplan–Meier statistics were used to compare groups.

Results. Fifty-six women were randomized and completed the study procedures. Race, age, gestational age, and cervical Bishop score were similar in both groups. Mean time to delivery occurred 21 hours sooner in the acupuncture group, but this difference did not reach statistical significance (p = 0.36). Compared to controls, women in the acupuncture group tended to be more likely to labor spontaneously (70% vs. 50%, p = 0.12) and less likely to deliver by cesarean section (39% vs. 17%, p = 0.07). Of women who were not induced, those in the acupuncture group were more likely to be delivered than the controls at any point after enrollment (p = 0.05).

Conclusion. Acupuncture is well tolerated among term nulliparous women and holds promise in reducing interventions that occur in post-term pregnancies.     

External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial

OBJECTIVE: To compare the success of external cephalic version using spinal analgesia with no analgesia among nulliparas. METHODS: A prospective randomized controlled trial was performed in a tertiary referral center delivery suite. Nulliparous women at term requesting external cephalic version for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia before the external cephalic version. An experienced obstetrician performed the external cephalic version. Primary outcome was successful conversion to vertex presentation. RESULTS: Seventy-four women were enrolled, and 70 analyzed (36 spinal, 34 no analgesia). Successful external cephalic version occurred among 24 of 36 (66.7%) women randomized to receive spinal analgesia compared with 11 of 34 (32.4%) without, P=.004 (95% confidence interval [CI] of the difference: 0.0954-0.5513). External cephalic version with spinal analgesia resulted in a lower visual analog pain score, 1.76+/-2.74 compared with 6.84+/-3.08 without, P<.001. A secondary analysis logistic regression model demonstrated that the odds of external cephalic version success was 4.0-fold higher when performed with spinal analgesia P=.02 (95% CI, odds ratio [OR] 1.2-12.9). Complete breech presentation before attempting external cephalic version increased the odds of success 8.2-fold, P=.001 (95% CI, OR 2.2-30.3). Placental position, estimated fetal weight, and maternal weight did not contribute to the success rate when spinal analgesia was used. There were no cases of placental abruption or fetal distress. CONCLUSION: Administration of spinal analgesia significantly increases the success rate of external cephalic version among nulliparous women at term, which allows possible normal vaginal delivery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00119184 LEVEL OF EVIDENCE: I.     

Effect of amoxicillin sulbactam in threatened preterm labour with intact membranes: a randomised controlled trial

OBJECTIVE: To determine whether treatment with amoxicillin-sulbactam in women with threatened idiopathic preterm labour will prolong the gestation and reduce preterm birth rates in a Latin-American population. METHODS: A double-blind, placebo-controlled, randomized trial was conducted in 96 women who were hospitalized for preterm labour between 24 and 34 weeks of gestation at the Pereira Rossell Hospital, in Montevideo, Uruguay. The primary outcome measure was prematurity. The sample size was calculated a priori based on the hospital database. Statistical analyses were performed using the t-test, chi square, weighted mean difference (WMD) and relative risk (RR) with their confidence intervals (95% CI). Analysis by intention-to-treat. RESULTS: Out of 47 patients assigned for antibiotics, 43 completed the treatment. There were no significant statistical differences between antibiotics and placebo group in prematurity (RR:1.04, 95% CI: 0.59, 1.84), prolongation of pregnancy (WMD:0.23, 95% CI: -0.96, 1.42) and other perinatal outcomes. CONCLUSION: Antibiotics did not prove to have benefits in improving perinatal outcomes in this Latin American population.     

Elective induction of labor at 39 weeks of gestation: a prospective randomized trial

OBJECTIVE: To clarify the safety of elective induction of labor at 39 weeks of gestation. STUDY DESIGN: Prospective randomized study. SUBJECTS AND METHODS: Uncomplicated nulliparas (N = 194) were randomly assigned at 36 weeks of gestation. Labor was electively induced in 63 women at 39 weeks of gestation in the active management group (I group, N = 98). Spontaneous labor onset was expected with semi-weekly nonstress test (NST) and amniotic fluid index (AFI) by 42 weeks of gestation in the expectant group (E group, N = 96). Perinatal events were compared between the 2 groups. RESULTS: A significantly higher incidence of meconium-stained amnios (19.4% vs 3.2%) and fetal resuscitation (16.7% vs 4.8%) was found in the E group than in the I group. Also, although a significantly higher incidence of epidural analgesia was noted in the I group (89%) than in the E group (54%) (labor onset > or = 39 weeks, N = 72), the duration of the 1st stage was shorter in I group and the duration of the 2nd stage was not significantly different. No other significant difference was noted between the 2 groups in terms of the rate of C-section, blood loss, incidence of pathological FHR, birth weight, Apgar score, umbilical arterial pH, or admission to NICU. CONCLUSION: Active management of labor at 39 weeks could be made as safely as expectant management with modified biophysical profile monitoring.     

A randomized controlled trial of acupuncture for initiation of labor in nulliparous women.

OBJECTIVE: To evaluate the utility of outpatient acupuncture for labor stimulation. METHODS: Nulliparous women at 39 4/7 weeks or greater with a singleton gestation and Bishop score of less than 7 were randomized to usual medical care (control group) versus usual care and three outpatient acupuncture treatments (acupuncture group). Each treatment consisted of eight needles applied to bilateral points LI4, SP6, UB31, and UB32. The primary outcome was time elapsed from the time of randomization to delivery. Secondary outcomes included rates of cesarean section and induction of labor. Medical records were abstracted for maternal demographic, medical, and delivery outcome data. A priori sample size calculation revealed that 56 women were required to detect a 72-hour difference in delivery time with a power of 83% and an alpha of 0.05. Student's t-test, Chi-square, and Kaplan-Meier statistics were used to compare groups. RESULTS: Fifty-six women were randomized and completed the study procedures. Race, age, gestational age, and cervical Bishop score were similar in both groups. Mean time to delivery occurred 21 hours sooner in the acupuncture group, but this difference did not reach statistical significance (p = 0.36). Compared to controls, women in the acupuncture group tended to be more likely to labor spontaneously (70% vs. 50%, p = 0.12) and less likely to deliver by cesarean section (39% vs. 17%, p = 0.07). Of women who were not induced, those in the acupuncture group were more likely to be delivered than the controls at any point after enrollment (p = 0.05). CONCLUSION: Acupuncture is well tolerated among term nulliparous women and holds promise in reducing interventions that occur in post-term pregnancies.     

Acupuncture in reproductive medicine: the motivations of infertile women to participate in a randomised controlled trial

Introduction: Randomised controlled trials are the gold standard in medical research and are challenging to conduct successfully since high numbers of participants are needed to produce robust results. Therefore, it is important to understand what motivates patients to participate in one, particularly in Reproductive Medicine where the conduct of RCTs is rare. Just as it is important to evaluate medical interventions, it is equally important that adjuvant therapies are properly assessed. There has been an increased interest in adding acupuncture to in vitro fertilisation (IVF) in the hope of increasing the chance of pregnancy and a live birth. However, evidence that acupuncture assists IVF outcomes is conflicted and insight into the experiences and motivations of infertile women is important. This paper describes how an invitation to participate in an RCT of acupuncture as an adjuvant to IVF was received by infertile women and how they processed their decision to participate.

Methods: In-depth interviews were conducted with 50 infertile women recruited from the RCT sample cohort. Recruitment aimed for maximum variation in social demographics. The data were saturated. Data pertaining to the theme of motivations to participate in an RCT were subjected to semantic thematic analysis.

Results: Two subthemes contained categories related to (a) the reasons women put forward for participation in an RCT, and (b) the rationale that underpinned and surrounded their decision. Women described themselves as active agents searching for a better outcome for their infertility or improved outcomes for women in the future. Their decision to participate in an RCT was motivated by factors such as opportunity, novelty and a value of science and was made after weighing various risks and benefits.

Conclusions: The decision to participate in an RCT was an informed one. Infertile women in a stressful treatment situation participated in an RCT in the hope of finding a therapy to improve IVF outcomes for themselves and for other infertile women.     

Aromatherapy in childbirth: a pilot randomised controlled trial

Objectives  We aimed to determine the feasibility of conducting a randomised controlled trial (RCT) on the use of aromatherapy during labour as a care option that could improve maternal and neonatal outcomes.
Design  RCT comparing aromatherapy with standard care during labour.
Setting  District general maternity unit in Italy.
Sample  Two hundred and fifty-one women randomised to aromatherapy and 262 controls.
Methods  Participants randomly assigned to administration of selected essential oils during labour by midwives specifically trained in their use and modes of application.
Main outcome measures  Intrapartum outcomes were the following: operative delivery, spontaneous delivery, first- and second-stage augmentation, pharmacological pain relief, artificial rupture of membranes, vaginal examinations, episiotomy, labour length, neonatal wellbeing (Apgar scores) and transfer to neonatal intensive care unit (NICU).
Results  There were no significant differences for the following outcomes: caesarean section (relative risk [RR] 0.99, 95% CI: 0.70–1.41), ventouse (RR 1.5, 95% CI: 0.31–7.62), Kristeller manoeuvre (RR 0.97, 95% CI: 0.64–1.48), spontaneous vaginal delivery (RR 0.99, 95% CI: 0.75–1.3), first-stage augmentation (RR 1.01, 95% CI: 0.83–1.4) and second-stage augmentation (RR 1.18, 95% CI: 0.82–1.7). Significantly more babies born to control participants were transferred to NICU, 0 versus 6 (2%), P = 0.017. Pain perception was reduced in aromatherapy group for nulliparae. The study, however, was underpowered.
Conclusion  This study demonstrated that it is possible to undertake an RCT using aromatherapy as an intervention to examine a range of intrapartum outcomes, and it provides useful information for future sample size calculations.