Mary E. Hannah

Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial

BACKGROUND For 3-4% of pregnancies, the fetus will be in the breech presentation at term. For most of these women, the approach to delivery is controversial. We did a randomised trial to compare a policy of planned caesarean section with a policy of planned vaginal birth for selected breech-presentation pregnancies. METHODS At 121 centres in 26 countries, 2088 women with a singleton fetus in a frank or complete breech presentation were randomly assigned planned caesarean section or planned vaginal birth. Women having a vaginal breech delivery had an experienced clinician at the birth. Mothers and infants were followed-up to 6 weeks post partum. The primary outcomes were perinatal mortality, neonatal mortality, or serious neonatal morbidity; and maternal mortality or serious maternal morbidity. Analysis was by intention to treat. FINDINGS Data were received for 2083 women. Of the 1041 women assigned planned caesarean section, 941 (90.4%) were delivered by caesarean section. Of the 1042 women assigned planned vaginal birth, 591 (56.7%) delivered vaginally. Perinatal mortality, neonatal mortality, or serious neonatal morbidity was significantly lower for the planned caesarean section group than for the planned vaginal birth group (17 of 1039 [1.6%] vs 52 of 1039 [5.0%]; relative risk 0.33 [95% CI 0.19-0.56]; p<0.0001). There were no differences between groups in terms of maternal mortality or serious maternal morbidity (41 of 1041 [3.9%] vs 33 of 1042 [3.2%]; 1.24 [0.79-1.95]; p=0.35). INTERPRETATION Planned caesarean section is better than planned vaginal birth for the term fetus in the breech presentation; serious maternal complications are similar between the groups.

Breech delivery at term: a critical review of the literature.

Objective: To determine whether planned vaginal or elective cesarean delivery is better for singleton term breech infants. Data sources: Articles that included singleton term pregnancies with breech presentation published in English between 1966 and September 1992 were searched through the Index Medicus, Oxford Database of Perinatal Trials, and MEDLINE. Methods of study selection: We reviewed 24 studies that presented results according to the intended mode of delivery in terms of the following adverse outcomes: perinatal mortality, low 5‐minute Apgar score, traumatic neonatal morbidity, overall short‐term neonatal morbidity, long‐term infant morbidity, and maternal morbidity and mortality. Data extraction and synthesis: The effect of planned vaginal delivery, compared with planned cesarean delivery, for each adverse outcome was determined by calculating a typical odds ratio. Perinatal mortality was higher for the planned vaginal delivery groups than for the elective cesarean groups, with a typical odds ratio of 3.86 (95% confidence interval [CI] 2.22‐6.69). Neonatal morbidity due to trauma was also higher for the planned vaginal delivery groups, with a typical odds ratio of 3.96 (95% CI 2.76‐5.67). Conclusion: The results suggest that planned vaginal delivery may be associated with higher perinatal mortality and morbidity rates than planned cesarean delivery. Because of selection bias in the majority of studies, differences in outcomes may be due to factors other than the planned method of delivery. An appropriately sized, randomized controlled trial is needed to answer this question definitively. (Obstet Gynecol 1993;82:605‐18)

Antibiotics for bacterial vaginosis or Trichomonas vaginalis in pregnancy: a systematic review.

OBJECTIVE: To determine whether antibiotic treatment for bacterial vaginosis or Trichomonas vaginalis during pregnancy decreases the risk of preterm birth and associated adverse outcomes. DATA SOURCES: Pre-MEDLINE and MEDLINE (1966–2003), EMBASE (1980–2003), and the Cochrane Library were searched using the keywords “bacterial vaginosis,” “Trichomonas,” “Trichomonas vaginalis,” “Trichomonas vaginitis,” “Trichomonas infections,” “pregnancy,” “pregnant,” “antibiotics,” and “antibiotic prophylaxis.” METHODS OF STUDY SELECTION: The search produced 1,888 titles, of which 1,256 abstracts were reviewed further. Of these, 1,217 were ineligible. Inclusion criteria were the following: randomized controlled trials in which antibiotics were compared with no antibiotic or placebo, for women in the second or third trimester of pregnancy with symptomatic or asymptomatic bacterial vaginosis or Trichomonas vaginalis, intact membranes, and not in labor. Exclusion criteria were as follows: published in a language other than English, dropout rate of more than 20% of women in either group, and lack of usable outcomes. Of the 39 papers reviewed in detail, 14 studies were included in the meta-analysis. TABULATION, INTEGRATION, AND RESULTS: One of the authors reviewed titles obtained from the searches, and 2 reviewers independently reviewed the abstracts, excluded those that were ineligible, identified eligible papers, and abstracted the data. For women with bacterial vaginosis, antibiotics reduced the risk of persistent infection but did not reduce the risk of preterm birth or the incidence of associated adverse outcomes for the general population or for any subgroup analyzed. For women with Trichomonas vaginalis, metronidazole reduced the risk of persistent infection but increased the incidence of preterm birth. CONCLUSION: Contrary to the conclusions of 3 recent systematic reviews, we found no evidence to support the use of antibiotic treatment for bacterial vaginosis or Trichomonas vaginalis in pregnancy to reduce the risk of preterm birth or its associated morbidities in low- or high-risk women.

International Multicentre Term Prelabor Rupture of Membranes Study: Evaluation of predictors of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term

OBJECTIVES Our purpose was to determine significant predictors for the development of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term. STUDY DESIGN Logistic regression analysis with odds ratios and 95% confidence intervals was used to determine the significant predictors of clinical chorioamnionitis and postpartum fever in women with prelabor rupture of membranes at term enrolled in this study. The study recently compared in a randomized controlled trial four strategies of management: induction with oxytocin, induction with prostaglandin, expectant management, and, if failed, induction with oxytocin or prostaglandin. RESULTS The following variables were significantly associated with clinical chorioamnionitis: (1) number of digital vaginal examinations: > 8, 7 to 8, 5 to 6, 3 to 4 (vs 0 to 2) (odds ratio 5.07, 3.80, 2.62, 2.06); (2) duration of active labor: > or = 12, 9 to < 12, 6 to < 9 hours (vs < 3 hours) (odds ratio 4.12, 2.94, 1.97); (3) meconium-stained amniotic fluid (odds ratio 2.28); (4) parity of 0 (odds ratio 1.80); (5) time from membrane rupture to active labor: > or = 48, 24 to < 48 hours (vs < 12 hours) (odds ratio 1.76, 1.77); and (6) group B streptococcal colonization (odds ratio 1.71). Variables significantly associated with postpartum fever were (1) clinical chorioamnionitis (odds ratio 5.37), (2) duration of active labor: > or = 12, 9 to < 12, 6 to < 9, 2 to < 6 hours (vs < 3 hours) (odds ratio 4.86, 3.53, 3.46, 3.04), (3) cesarean section, operative vaginal delivery (odds ratio 3.97, 1.86), (4) group B streptococcal colonization (odds ratio 1.88), and (5) maternal antibiotics before delivery (odds ratio 1.94). CONCLUSIONS Increasing numbers of digital vaginal examinations, longer duration of active labor, and meconium staining of the amniotic fluid were the most important risk factors for the development of clinical chorioamnionitis in women with prelabor rupture of membranes at term. The most important risk factors for the development of postpartum fever were clinical chorioamnionitis, increasing duration of active labor, and cesarean section delivery.

Evaluating the benefits of a patient information video during the informed consent process

The study objective was to evaluate the effect of a patient information video during the informed consent process of a perinatal trial. Ninety women, between 19 and 33 weeks gestation, were randomised to receive written information about this perinatal trial and watch an information video or to receive written information only. Participants completed a questionnaire immediately after entry and 2-4 weeks later assessing knowledge of; feelings about the worth of; and willingness for future participation in the perinatal trial. When initially asked, more women who watched the video thought they would consent to the study (chi 2 = 6.3; df = 1; P = 0.01). No differences in knowledge about the perinatal trial were found initially, but 2-4 weeks later more knowledge had been retained by women who had watched the video (chi 2 = 6.7; df = 1; P = 0.01). These results suggest that a patient information video combined with an information sheet may result in greater participation in a research trial and may increase womens knowledge of a specific health problem and related research trial.

International Multicenter Term PROM Study: Evaluation of predictors of neonatal infection in infants born to patients with premature rupture of membranes at term

OBJECTIVE Our objective was to determine significant predictors for the development of neonatal infection in infants born to patients with premature rupture of membranes at term. STUDY DESIGN Multivariate analysis was used to determine the significant predictors of neonatal infection in infants born to women with premature rupture of the membranes who were enrolled in the Term PROM Study. In a randomized, controlled trial, the Term PROM Study recently compared induction of labor with expectant management for premature rupture of membranes at term. RESULTS The following variables were identified as independent predictors of neonatal infection: clinical chorioamnionitis (odds ratio 5.89, P < .0001), positive maternal group B streptococcal status (vs negative or unknown, odds ratio 3.08, P < .0001), 7 to 8 vaginal digital examinations (vs 0 to 2, odds ratio 2.37, P = .04), 24 to < 48 hours from membrane rupture to active labor (vs < 12 hours, odds ratio 1.97, P = .02), > or = 48 hours from membrane rupture to active labor (vs < 12 hours, odds ratio 2.25, P = .01), and maternal antibiotics before delivery (odds ratio 1.63, P = .05). CONCLUSIONS Among infants born to patients with premature rupture of membranes at term, clinical chorioamnionitis and maternal colonization with group B streptococci are the most important predictors of subsequent neonatal infection.

Impact of the International Term Breech Trial on Clinical Practice and Concerns: A Survey of Centre Collaborators

OBJECTIVE The purpose of this study was to determine what impact the International Term Breech Trial had had in different settings and to elicit any concerns among collaborators regarding the implementation of a policy of planned Caesarean section for term breech babies. METHODS We mailed a questionnaire to all Term Breech Trial collaborators. The questionnaire asked 3 open-ended questions about the impact of the trial, about concerns with implementing planned Caesarean section for term breech babies, and about whether information as to the relative costs of planned Caesarean section versus planned vaginal birth would be helpful. Frequencies of responses were calculated for centres in countries classified as having a low or a high national perinatal mortality rate (< or = 20/1000 vs. > 20/1000, respectively) according to the figures published by the World Health Organization in 1996. RESULTS We received responses from 80 centres in 23 countries. Most centres (92.5%) stated that clinical practice had changed to planned Caesarean section for most or all term breech babies. The majority of centres (66.3%) had no difficulties or concerns with implementing a policy of planned Caesarean section for term breech babies. Most centres (85.0%) indicated that an analysis of relative costs would not affect clinical practice in their setting. CONCLUSION Clinical practice has changed to planned Caesarean section in most collaborating centres, given the results of the Term Breech Trial.

Planned elective cesarean section: A reasonable choice for some women?

Agrowing number of women are requesting delivery by elective cesarean section without an accepted “medical indication,” and physicians are uncertain how to respond. This trend is due in part to the general perception that cesarean delivery is much safer now than in the past and to the recognition that most studies looking at the risks of cesarean section may have been biased, as women with medical or obstetric problems were more likely to have been selected for an elective cesarean section. Thus, the occurrence of poor maternal or neonatal outcomes may have been due to the problem necessitating the cesarean delivery rather than to the procedure itself. The only way to avoid this selection bias is to conduct a trial in which women would be randomly assigned to undergo a planned cesarean section or a planned vaginal birth. When this was done in the international randomized Term Breech Trial involving 2088 women with a singleton fetus in breech presentation at term, the risk of perinatal or neonatal death or of serious neonatal morbidity was significantly lower in the planned cesarean group, with no significant increase in the risk of maternal death or serious maternal morbidity. 1

The effect of indomethacin tocolysis in preterm labour on perinatal outcome: a randomised placebo-controlled trial

Objective To determine whether indomethacin tocolysis in preterm labour is associated with a better perinatal outcome than placebo.

Factors associated with adverse perinatal outcome in the Term Breech Trial

BACKGROUND In the Term Breech Trial, the risk of adverse perinatal outcome was lower with planned cesarean section versus planned vaginal birth. We undertook secondary analyses to determine factors associated with adverse perinatal outcome. STUDY DESIGN By using multiple logistic regression analyses, we determined the effect of prelabor cesarean section, cesarean section during early labor, cesarean section during active labor versus vaginal birth, and other factors, on adverse perinatal outcome. For 1384 fetuses delivered after labor, we determined the effect of variables associated with labor on adverse perinatal outcome. RESULTS The risk of adverse perinatal outcome was lowest with prelabor cesarean section (odds ratio [OR]=0.13) and highest with vaginal birth. For those delivered after labor, labor augmentation (P=.007), birth weight less than 2.8 kg (P=.003), and longer time between pushing and delivery (P<.001) increased the risk, whereas the presence of an experienced clinician at delivery (P=.004) reduced the risk of adverse perinatal outcome. CONCLUSION Breech infants at term are best delivered by prelabor cesarean section.