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Background Labor pain during childbirth can have devastating effects on the progress of labor, mother, and fetus. Consequently, the management of labor pain is crucial for the well-being of the mother and fetus. Transcutaneous electrical nerve stimulation (TENS) is a non -pharmacological analgesic technique. It uses a low-voltage electrical current to activate descending inhibitory systems in the central nervous system to relieve pain. This study aimed to determine the effects of TENS therapy in the first stage of labor. Methods In this single-blind randomized controlled trial, we screened low-risk pregnant women who anticipated spontaneous vaginal delivery. Women were assigned (1:1) to either the experimental group (received TENS therapy in the first stage of labor) or the control group (received routine obstetric care). The women, midwives, and researchers working in the gynecology and obstetric department were aware of the treatment group, but statisticians analysis the data were blinded. The primary outcome was labor pain intensity, assessed by visual analog scale (VAS) immediately after the randomization, at 30, 60, and 120 min after TENS therapy, and 2–24 h post-delivery. We used SPSS 21.0 software in data analysis. An independent sample t-test compared the mean VAS scores and labor duration between groups. A Chi-square test was employed to compare categorical variables between the groups. A significant level of ≤0.05 was statistically significant. Results A total of 326 pregnant women were eligible: experimental group ( n  = 161) and control group ( n  = 165). The experimental group had statistically significantly lower mean VAS scores at a different time (30, 60, and 120 min post-intervention and 2–24 h post-delivery) than the control group ( p  < 0.001). The experimental group demonstrated a statistically significant shorter duration of the active labor phase than the control group ( p  < 0.001). Conclusion This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase. Trial registration ISRCTN registry, ISRCTN23857995 . Registered on 11/12/2020, ‘retrospectively registered.

In this randomized trial comparing delivery strategies in women with twin gestation, planned cesarean section did not significantly increase or decrease the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. Because of assisted reproductive technologies, twin pregnancy occurs more frequently now than in the past, and it complicates 2 to 3% of all births. 1 , 2 Twins are at higher risk for an adverse perinatal outcome than singletons. 3 , 4 Planned cesarean section, as compared with planned vaginal delivery, may reduce this risk. 5 Although a small, randomized, controlled trial did not show better perinatal outcomes with planned cesarean section than with planned vaginal delivery, 6 several cohort studies have shown a reduced risk of adverse perinatal outcomes for both twins, or for the second twin, when twins at or near term were delivered . . .

The use of azithromycin reduces maternal infection in women during unplanned cesarean delivery, but its effect on those with planned vaginal delivery is unknown. Data are needed on whether an intrapartum oral dose of azithromycin would reduce maternal and offspring sepsis or death. In this multicountry, placebo-controlled, randomized trial, we assigned women who were in labor at 28 weeks' gestation or more and who were planning a vaginal delivery to receive a single 2-g oral dose of azithromycin or placebo. The two primary outcomes were a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis. During an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit. A total of 29,278 women underwent randomization. The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P<0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events. Among women planning a vaginal delivery, a single oral dose of azithromycin resulted in a significantly lower risk of maternal sepsis or death than placebo but had little effect on newborn sepsis or death. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; A-PLUS ClinicalTrials.gov number, NCT03871491.).

In this multicenter trial comparing immediate (≤10 seconds) with delayed (≥60 seconds) clamping of the umbilical cord after preterm birth, there was no significant difference between groups in the primary composite outcome of death or major morbidity by 36 weeks of postmenstrual age.

There is an ongoing debate concerning which guidelines and monitoring tools are most beneficial for assessing labour progression, to help prevent use of intrapartum caesarean section (ICS). The WHO partograph has been used for decades with the assumption of a linear labour progression; however, in 2010, Zhang introduced a new guideline suggesting a more dynamic labour progression. We aimed to investigate whether the frequency of ICS use differed when adhering to the WHO partograph versus Zhang's guideline for labour progression. We did a multicentre, cluster-randomised controlled trial at obstetric units in Norway, and each site was required to deliver more than 500 fetuses per year to be eligible for inclusion. The participants were nulliparous women who had a singleton, full-term fetus with cephalic presentation, and who entered spontaneous active labour. The obstetric units were treated as clusters, and women treated within these clusters were all given the same treatment. We stratified these clusters by size and number of previous caesarean sections. The clusters containing the obstetric units were then randomly assigned (1:1) to the control group, which adhered to the WHO partograph, or to the intervention group, which adhered to Zhang's guideline. The randomisation was computer-generated and was done in the Unit of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway, and investigators in this unit had no further involvement in the trial. Our study design did not enable masking of participants or health-care providers, but the investigators who were analysing the data were masked to group allocation. The primary outcome was use of ICS during active labour (cervical dilatation of 4–10 cm) in all participating women. The Labour Progression Study (LaPS) is registered with ClinicalTrials.gov, number NCT02221427. Between Aug 1, 2014, and Sept 1, 2014, 14 clusters were enrolled in the LaPS trial, and on Sept 11, 2014, seven obstetric units were randomly assigned to the control group (adhering to the WHO partograph) and seven obstetric units were randomly assigned to the intervention group (adhering to Zhang's guideline). Between Dec 1, 2014, and Jan 31, 2017, 11 615 women were judged to be eligible for recruitment in the trial, which comprised 5421 (46·7%) women in the control group units and 6194 (53·3%) women in the intervention group units. In the control group, 2100 (38·7%) of 5421 women did not give signed consent to participate and 16 (0·3%) women abstained from participation. In the intervention group, 2181 (35·2%) of 6194 women did not give signed consent to participate and 41 (0·7%) women abstained from participation. 7277 (62·7%) of 11 615 eligible women were therefore included in the analysis of the primary endpoint. Of these women, 3305 (45·4%) participants were in an obstetric unit that was randomly assigned to the control group (adhering to the WHO partograph) and 3972 (54·6%) participants were in an obstetric unit that was randomly assigned to the intervention group (adhering to Zhang's guideline). No women dropped out during the trial. Before the start of the trial, ICS was used in 9·5% of deliveries in the control group obstetric units and in 9·3% of intervention group obstetric units. During our trial, there were 196 (5·9%) ICS deliveries in women in the control group (WHO partograph) and 271 (6·8%) ICS deliveries in women in the intervention group (Zhang's guideline), and the frequency of ICS use did not differ between the groups (adjusted relative risk 1·17, 95% CI 0·98–1·40; p=0·08; adjusted risk difference 1·00%, 95% CI −0·1 to 2·1). We identified no maternal or neonatal deaths during our study. We did not find any significant difference in the frequency of ICS use between the obstetric units assigned to adhere to the WHO partograph and those assigned to adhere to Zhang's guideline. The overall decrease in ICS use that we observed relative to the previous frequency of ICS use noted in these obstetric units might be explained by the close focus on assessing labour progression more than use of the guidelines. Our results represent an important contribution to the discussion on implementation of the new guideline. Østfold Hospital Trust.

In women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia. In this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing. Between Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79–0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08–1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group. There is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery. National Institute for Health Research Health Technology Assessment Programme.

Continuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes. In this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152. Between Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups—172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82–1·25). At 2 years, no significant differences were noted in terms of developmental assessment. Use of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies. National Institute for Health Research.

Background In order to reduce the complications of perineal damage and the pain caused by it for the mother, this study was conducted to determine the effect of warm perineal compress on perineal trauma (1st-, 2nd-, 3rd-, and 4th-degree perineal tears), postpartum pain, intact perineum (primary outcomes), episiotomy, length of the second stage, and APGAR score at 1 and 5 min after childbirth (secondary outcome). Methods PubMed, Scopus, Cochrane Central Register of Controlled Trials, Google Scholar, Web of Science, SID, Magiran, and ClinicalTrials.gov were searched to identify the relevant articles from inception to November 1, 2022, with language restriction (only English and Persian). A manual search was also performed. Risk of bias 2 (RoB2) and ROBIN-I were employed to evaluate the quality of the included papers. Meta-analysis was conducted using RevMan 5.3. Heterogeneity was assessed using I 2 . In cases with high heterogeneity, subgroup analysis was utilized based on the parity and ethnicity, and time of pain measurement after delivery also a random-effects model was used instead of a fixed-effects model. Trial sequential analysis (TSA) was performed for the primary outcomes. The certainty of evidence was assessed using the GRADE approach. Results A total number of 228 articles were found in databases. Of these articles, eighty-six were screened by title, 27 by abstract, and 21 by full text. Finally, 14 articles were included, of which ten were RCT and four were non-RCT. Meta-analysis results revealed that warm perineal compress significantly reduced perineal pain (RR 0.23, 95% CI 0.08–0.66; P = 0.0006), average pain (SMD − 0.73, 95% CI 1.23 to − 0.23; P = 0.004), second-degree perineal tear (RR 0.65, 95% CI 0.54–0.79; P˂0.00001), third-degree perineal tear (RR 0.32, 95% CI 0.15–0.67; P = 0.003), fourth-degree perineal tear (RR 0.11, 95% CI 0.01–0.87; P = 0.04), episiotomy (RR 0.63, 95% CI 0.46–0.86; P = 0.004), and intact perineum significantly increased (RR 3.06, 95% CI 1.79–5.22; P < 0.0001) compared to the control group. However, there was no statistically significant difference in terms of first-degree tear (RR 1.04, 95% CI 0.86–1.25; P = 0.72), length of the second stage of labor (MD − 0.60, 95% CI − 2.43 to 1.22; P = 0.52), the first minute (MD − 0.03, 95% CI − 0.07 to 0.02; P = 0.24) and the fifth minute Apgar score (MD − 0.02, 95% CI − 0.07 to 0.03; P = 0.46) between the two groups. Conclusion Warm perineal compress administered during the second stage of labor reduce postpartum pain, second and third-degree perineal tears, and episiotomy rate while it increases the incidence of intact perineum compared to the control group.

Purpose This study aimed to examine the effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction. Methods The study used a randomized controlled trial design. All 120 primiparous pregnant women were randomly assigned to the intervention (IG) and control groups (CG). After the cervical dilatation reached 4 cm, the pregnant women in the IG performed birth ball exercises, adhering to the birth ball guide created by the researcher. No intervention was made in the control group other than standard midwifery care practices. Results The labor pain level between the groups (VAS 1-when cervical dilatation was 4 cm) was similar to each other. The labor pain level (VAS 2- when cervical dilatation was 9 cm) scores of the women in the IG were significantly lower than those in the CG ( p <  0.05). The time between the active phase of labor until dilatation is complete and the time until the baby's head comes out after full dilatation was found to be statistically significantly shorter in the IG compared to the CG ( p <  0.05). Childbirth comfort and satisfaction mean scores between the groups were found to be statistically insignificant ( p >   0.05). Conclusion As a result of the study, it was determined that the birth ball exercise significantly reduced labor pain and labor time. We recommend that the birth ball exercise be applied to all low-risk pregnant women because it helps fetal descent and cervical dilatation, and shortens labor pain and delivery time.

Background High levels of childbirth fear impact birth preparation, obstetric outcomes and emotional wellbeing for around one in five women living in developed countries. Higher rates of obstetric intervention and caesarean section (CS) are experienced in fearful women. The efficacy of interventions to reduce childbirth fear is unclear, with no previous randomised controlled trials reporting birth outcomes or postnatal psychological wellbeing following a midwife led intervention. Method Between May 2012 and June 2013 women in their second trimester of pregnancy were recruited. Women with a fear score ≥ 66 on the Wijma Delivery Expectancy / Experience Questionnaire (W-DEQ) were randomised to receive telephone psycho-education by a midwife, or usual maternity care. A two armed non-blinded parallel (1:1) multi-site randomised controlled trial with participants allocated in blocks of ten and stratified by hospital site and parity using an electronic centralised computer service. The outcomes of the RCT on obstetric outcomes, maternal psychological well-being, parenting confidence, birth satisfaction, and future birth preference were analysed by intention to treat and reported here. Results 1410 women were screened for high childbirth fear (W-DEQ ≥66). Three hundred and thirty-nine ( n  = 339) women were randomised (intervention n  = 170; controls n  = 169). One hundred and eighty-four women (54 %) returned data for final analysis at 6 weeks postpartum (intervention n  = 91; controls n  = 93). Compared to controls the intervention group had a clinically meaningful but not statistically significant reduction in overall caesarean section (34 % vs 42 %, p  = 0.27) and emergency CS rates (18 % vs 25 %, p  = 0.23). Fewer women in the intervention group preferred caesarean section for a future pregnancy (18 % vs 30 %, p  = 0.04). All other obstetric variables remained similar. There were no differences in postnatal depression symptoms scores, parenting confidence, or satisfaction with maternity care between groups, but a lower incidence of flashbacks about their birth in the intervention group compared to controls (14 % vs 26 %, p  = 0.05). Postnatally women who received psycho-education reported that the ‘decision aid’ helped reduce their fear (53 % vs 37 %, p  = 0.02). Conclusion Following a brief antenatal midwife-led psycho-education intervention for childbirth fear women were less likely to experience distressing flashbacks of birth and preferred a normal birth in a future pregnancy. A reduction in overall CS rates was also found. Psycho-education for fearful women has clinical benefits for the current birth and expectations of future pregnancies. Trial registration Australian New Zealand Controlled Trials Registry ACTRN12612000526875 , 17th May 2012