Evaluating the efficacy of outpatient use of isosorbide mononitrate on cervical ripening in pregnant women with unfavourable cervix

The aim of the present study was to evaluate the efficacy of outpatient administration of nitric oxide donor isosorbide mononitrate for cervical ripening. A randomised clinical trial was performed on term pregnant women with Bishop Score < 6. In the case group, Isosorbide-5-mononitrate capsule and in the control group, placebo was inserted in the posterior vaginal fornix for two consecutive days. The main outcomes were increases in Bishop Score after 48 hours of intervention, number of vaginal deliveries and interval from intervention to delivery. There was a significant increase of the mean Bishop score in the isosorbide group [3.57 ± 1.12 VS 1.54 ± 1.42 respectively (p = .001)]. The other outcome variables did not show a significant difference between the two groups except for headache which was significantly more in the case group. No cases of tachysystole were observed in the two groups. Additionally, haemoglobin levels after delivery did not show a significant difference between the two groups.Impact statement: What is already known on this subject? Cervical ripening in women with an unfavourable cervix and having an indication for induction of labour is an important issue in modern obstetrics. Different methods have been used for cervical ripening and induction of labour including mechanical (i.e. laminaria tents, Dilapan-S, foley catheter), medical (i.e. PGs) and supportive methods. There is no consensus on the best option for cervical ripening What will the results of this study add to the current knowledge of this subject? Outpatient administration of nitric oxide could affect cervical ripening without a significant improvement in the duration of different stages of labour, intervention to delivery interval and number of vaginal deliveries. What are the implications of these findings for clinical practice and/or further research? Due to the contradictory results of various studies, more studies should be performed with greater sample size to evaluate nitric oxide donor isosorbide mononitrate effect on labour duration and reducing caesarean deliveries. Additional data is needed to assess the real impact of NO donors on different stages of labour and its implications

Efficacy comparison of titrated oral solution of misoprostol and intravenous oxytocin on labour induction in women with full-term pregnancy

A double-blind randomised trial was conducted on women with gestational age of 40–42 weeks of pregnancy and Bishop score of more than 5. The first group received oxytocin infusion and the second group received a titrated oral solution of misoprostol. Then, the two groups were compared by the primary outcome (the number of deliveries in the first 24 hours of intervention). The two groups did not have any significant difference in maternal and gestational age at the time of intervention, primary Bishop score, parity and neonatal weight. The number of deliveries in the first 24 hours was greater in the misoprostol group. Duration of onset of intervention to proper contractions was longer in the misoprostol group. However, the number of deliveries between 6–12 hours, 12–18 hours and 18–24 hours after induction was greater in the misoprostol group. The incidence of tachysystole and meconium was greater in the misoprostol group.Impact statement What is already known on this subject? Labour induction is widely used where the continuation of pregnancy might be dangerous for the mother or the baby. Of the various methods used for induction, misoprostol which is a prostaglandin E1 analogue has been reviewed more in recent years. Misoprostol has various routes of administration but in most studies only vaginal administration has been evaluated, leaving us with limited data about oral administration. What do the results of this study add? Oral misoprostol is a suitable method for labour induction and can be used as an alternative to oxytocin. What are the implications of these findings for clinical practice and/or further research? Misoprostol is not expensive, has a long shelf life, accessible in underdeveloped countries and rural areas and has several routes of administrations such as oral, sublingual and vaginal. Despite the fact that the oral route of misoprostol has a fast absorption and easier administration, there are relatively few studies assessing the the use of the oral route of misoprostol. Misoprostol is a suitable method for Labour induction and it has the potentials of being used as an alternative for oxytocin, however, the optimum dosages, the preferred route of administration, the maximum dose, the maximum time for administration, and maternal and neonatal safety should be studied more

Comparison between two doses of betamethasone administration with 12 hours vs. 24 hours intervals on prevention of respiratory distress syndrome: a randomised trial

The purpose of the present study was to compare the effect of a two-dose administration of betamethasone with 12 hours interval vs. 24 hours interval on neonatal respiratory distress syndrome (RDS). The study was performed as a randomised clinical trial on 201 pregnant women with a gestational age of 26–34 weeks. In one group 12 mg of betamethasone every 12 hours for two doses and in the other group 12 mg of betamethasone every 24 hours for two doses were prescribed intramuscularly. There were no significant differences between the two groups according to maternal age, parity, gravidity, BMI, neonatal sex, need to surfactant, NICU admission, NICU stay, neonatal death, neonatal sepsis and Apgar score at minutes 1 and 5, but the gestational age at the beginning of the study and delivery receiving complete course of betamethasone and neonatal weight were lower in 24 hours group. RDS, necrotising enterocolitis, intra-ventricular haemorrhage and chorioamnionitis were more in the 24 hours’ group. Multiple regression analysis showed that RDS and IVH (p = .022, RR = 0.07, CI95% 0.006–0.96 and p = .013; RR = 0.9, CI95% 0.1–0.89, respectively) were more in the 24 hours group and neonatal death (p = .034, RR = 4.7, CI95% 1.07–16.2) and NEC (p = 0.038, RR = 2.5, CI95% 1.7–3.7), were more in the 12 hours group. In conclusion, it seems that 12 hours interval betamethasone therapy may be considered as an alternative treatment in the case of preterm labour for acceleration of lung maturity; however, it is suggested that more studies should be performed on this issue and various morbidities.IMPACT STATEMENT What is already known on this subject: Administration of a single course of corticosteroids in all women with a gestational age of 24–34 weeks of pregnancy who are at risk for preterm labour and delivery has been recommended. The accepted regimen by National Institutes of Health (NIH) is an injection of betamethasone for two doses with 24 hours interval. What do the results of this study add: Twelve hours interval betamethasone therapy may be considered as an alternative treatment in the cases of preterm labour for acceleration of lung maturity. What are the implications of these findings for clinical practice and/or further research: Prescription of two doses (complete regimen) is more important than the interval between two doses for obtaining the maximum effect in a preterm birth

Comparison between two doses of betamethasone administration with 12 hours vs. 24 hours intervals on prevention of respiratory distress syndrome: a randomised trial

The purpose of the present study was to compare the effect of a two-dose administration of betamethasone with 12 hours interval vs. 24 hours interval on neonatal respiratory distress syndrome (RDS). The study was performed as a randomised clinical trial on 201 pregnant women with a gestational age of 26–34 weeks. In one group 12 mg of betamethasone every 12 hours for two doses and in the other group 12 mg of betamethasone every 24 hours for two doses were prescribed intramuscularly. There were no significant differences between the two groups according to maternal age, parity, gravidity, BMI, neonatal sex, need to surfactant, NICU admission, NICU stay, neonatal death, neonatal sepsis and Apgar score at minutes 1 and 5, but the gestational age at the beginning of the study and delivery receiving complete course of betamethasone and neonatal weight were lower in 24 hours group. RDS, necrotising enterocolitis, intra-ventricular haemorrhage and chorioamnionitis were more in the 24 hours’ group. Multiple regression analysis showed that RDS and IVH (p = .022, RR = 0.07, CI95% 0.006–0.96 and p = .013; RR = 0.9, CI95% 0.1–0.89, respectively) were more in the 24 hours group and neonatal death (p = .034, RR = 4.7, CI95% 1.07–16.2) and NEC (p = 0.038, RR = 2.5, CI95% 1.7–3.7), were more in the 12 hours group. In conclusion, it seems that 12 hours interval betamethasone therapy may be considered as an alternative treatment in the case of preterm labour for acceleration of lung maturity; however, it is suggested that more studies should be performed on this issue and various morbidities.IMPACT STATEMENTWhat is already known on this subject: Administration of a single course of corticosteroids in all women with a gestational age of 24–34 weeks of pregnancy who are at risk for preterm labour and delivery has been recommended. The accepted regimen by National Institutes of Health (NIH) is an injection of betamethasone for two doses with 24 hours interval.What do the results of this study add: Twelve hours interval betamethasone therapy may be considered as an alternative treatment in the cases of preterm labour for acceleration of lung maturity.What are the implications of these findings for clinical practice and/or further research: Prescription of two doses (complete regimen) is more important than the interval between two doses for obtaining the maximum effect in a preterm birth.</p

Dexamethasone versus placebo for prevention of nausea, vomiting and pain after open total abdominal hysterectomy

Post-operative nausea and vomiting (PONV) is a disturbing issue. Dexamethasone has been suggested for the prevention of PONV. The aim of the present study was to evaluate the efficacy of dexamethasone as an anti-emetic and analgesic following total abdominal hysterectomy. The study was performed as a double blind, placebo-controlled randomised clinical trial on 102 women undergoing an open total abdominal hysterectomy. The intervention group received 8 mg dexamethasone 1 h before surgery, and the control group received a placebo. The total number of emesis episodes during the 24 h after surgery did not show significant difference between the two groups, however, the number of emesis episodes in hours 2 and 4 after the surgery were less in the intervention group, but not in hours 0, 6, 12 and 24. The nausea severity in hours 0, 2, 4, 6 and 12 after the surgery, was less in the intervention group. The severity of pain was not different between the two groups.IMPACT STATEMENT What is already known on this subject? Post-operative nausea and vomiting (PONV) is an important and disturbing issue. It is one of the most common problems following gynaecological surgeries including open total abdominal hysterectomy (TAH). Dexamethasone has been suggested as a prophylaxis for the prevention of PONV. What do the results of this study add? Dexamethasone 8 mg is effective for the prevention of late onset PONV (after 2 h of surgery) in the cases of open total abdominal hysterectomy. However, it has no effect on PONV immediately following surgery (hour 0) and pain. What are the implications of these findings for clinical practice and/or further research? Dexamethasone can be considered as an effective prophylaxis for PONV for the first 24 h after an open total abdominal hysterectomy, but it has limited effects on the management of early onset of PONV; between 0 and 2 h after surgery. Since the highest rates of emesis episodes and nausea severity are at this time, it is suggested to combine another rapid onset medication with dexamethasone. Also, dexamethasone, 8 mg, cannot be considered for pain relief after an open total abdominal hysterectomy. Higher amounts of dexamethasone should be evaluated for this purpose, in order to find appropriate dosages

Comparison between maternal and neonatal outcome of PPROM in the cases of amniotic fluid index (AFI) of more and less than 5 cm

The study was performed on pregnant women with a gestational age of 26–32 weeks of pregnancy, who had been admitted to the hospital with a confirmed diagnosis of premature rupture of membranes. In all eligible women, ultrasounds were performed for the evaluation of amniotic fluid index. Then, the women were divided into two groups according to amniotic fluid index of ≥5 cm and <5 cm. These women were followed and monitored up to delivery. The women of the two groups did not have significant difference between them according to age, gestational age at the time of ruptured membrane, body mass index, gravidity, parity, gestational age at delivery and route of delivery. Maternal morbidities including chorioamnionitis, placental abruption, uterine atony after delivery and retention of placenta did not show significant difference between the two groups. There was no significant difference between the two groups’ amniotic fluid index <5 cm and amniotic fluid index ≥5 cm, regarding neonatal morbidities, except for neonatal sepsis and neonatal death, which were higher in the amniotic fluid index <5 cm group [7(14.6%) versus 1(2.3%), p = .039, RR = 7.7 (95%CI 0.04–0.06) and 11(30.9%) versus 2(4.7%), p = .013, RR = 6.095 (95%CI = 1.26–29.31)]. In the subgroups of two categories of gestational ages of 260–296 and 300–346, neonatal morbidities were higher in the amniotic fluid index <5 cm group. The results suggest that amniotic fluid index <5 cm should be considered as a warning sign for predicting poor prognosis of pregnancy complicated by preterm premature rupture of membranes.Impact statement What is already known on this subject? In a retrospective study in 1993, the relationship between oligohydramnios (which was defined as the largest single packet of fluid less than 2 × 2 cm) at the time of hospital admission, and the outcome of mother, foetus and neonates in a gestational age of less than 35 weeks of pregnancy was evaluated. In the oligohydramnios group, chorioamnionitis and funistis were more common. Also, the mean gestational age at the time of delivery and neonatal weight was less than that of the normal amniotic fluid group. According to these results, it was concluded that a low amniotic fluid volume in the women with preterm premature rupture of membranes (PPROM) can be considered as a prognostic factor in the cases of conservative management of PPROM. In contrast, the other study, which was performed on a larger sample size (290 patients), could not show more cases of amnionitis in the cases of amniotic fluid index (AFI) of less than 5 cm; however, the latency period was shorter in comparison with AFI of more than 5 cm. What do the results of this study add? Chorioamnionitis, placental abruption and uterine atony after delivery, retention of placenta and route of delivery did not show a significant difference between the two groups. Respiratory distress syndrome (RDS), need of surfactant and intubation, intra ventricular haemorrhage (IVH) and duration of neonatal intensive care unit (NICU) admission did not show a significant difference between the two groups; however, the rate of neonatal sepsis and neonatal death were higher in the AFI <5 cm group. What are the implications of these findings for clinical practice and/or further research? The results suggest that AFI <5 cm should be considered as a warning sign for predicting poor prognosis of pregnancy complicated by PPROM