Efficacy and safety of celecoxib for treatment of mild to moderate postpartum depression: a randomized, double-blind, placebo-controlled trial.

PURPOSE: Evidence has demonstrated the roles of inflammatory processes in pathogenesis of depression. We aim to assess the effects of adjunctive celecoxib with cognitive behavioral therapy (CBT), an anti-inflammatory agent, in treatment of postpartum depression and on levels of Brain-derived neurotrophic factor (BDNF) and inflammatory cytokines. METHODS: This was a randomized, double-blind, placebo-controlled trial to investigate the effects of adjunctive celecoxib with CBT on postpartum depression. Fifty outpatient women with postpartum depression, participated in this study. Patients randomly received either a celecoxib capsule twice a day or a placebo capsule twice a day for 6 weeks. Patients were assessed using the Hamilton Depression Rating Scale (HDRS) and the adverse event checklist at baseline and weeks 2, 4, and 6. RESULTS: Patients in the celecoxib group showed a greater decline in HDRS scores from baseline to all three study time points compared to the placebo group (p = 0.12 for week 2, p = 0.001 for week 4, p < 0.001 for week 6). Rate of response to treatment was significantly higher in the celecoxib group compared to the placebo group at week 4 (60 vs 24%, p = 0.010) and week 6 (96 vs 44%, p < 0.001). Rate of remission was significantly higher in the celecoxib group compared to the placebo group at week 4 (52 vs 20%, p = 0.018) and week 6 (96 vs 36%, p < 0.001). Levels of most inflammatory markers were significantly lower in the celecoxib group compared to the placebo group at week 6. Levels of BDNF were significantly higher in the celecoxib group compared to the placebo group at week 6 (p < 0.001). CONCLUSIONS: Findings suggest adjunctive celecoxib is an effective treatment for the improvement of postpartum depressive symptoms.

Maternal and fetal outcomes of pregnancies associated with single versus double abnormal values in 100 gr glucose tolerance test.

Purpose of the study: Comparing maternal and fetal outcomes in pregnancies associated with single versus double abnormal values in 100 gr oral glucose tolerance test (OGTT). Methods: This cohort study was performed in Arash women's Hospital, Tehran, Iran from 2019 to 2020. Patients with normal fasting blood sugar (FBS) tests were divided into two groups according to their OGTT results. The first group had a single abnormal value in their OGTT and the second group showed two abnormal values. Both groups were followed regularly until the end of pregnancy. Results: Our results showed higher rates of macrosomia (birth of newborns weighed over 4 kg) and the need for pharmacological treatment for the management of GDM in the second group (P = 0.05). There were no differences between the two groups in terms of other maternal (polyhydramnios, shoulder dystocia, operative vaginal delivery, atony, postpartum bleeding, cesarean delivery, preeclampsia, and IUFD) and fetal outcomes (Apgar score, seizure, NICU admission, and hypoglycemia in the first 24 h). Conclusion: We found no significant differences between pregnant women with single and double abnormal values in 100 gr OGTT regarding maternal and neonatal outcomes, except for macrosomia and need for pharmaceutical treatment.

The effect of probiotic supplementation on the risk of gestational diabetes mellitus among high-risk pregnant women: A parallel double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Based on a comprehensive search, we realized that the findings of the available literature are contradictory, and also limited data are available on Middle Eastern populations in terms of probiotic supplementation during the pregnancy. Therefore, the current double-blind, randomized, placebo-controlled clinical trial was carried out to investigate the effects of probiotic supplementation during pregnancy on the risk of gestational diabetes mellitus and also other maternal and neonatal outcomes. MATERIALS AND METHODS: The pregnant women were randomized to either received probiotic supplement (n = 271) or placebo (n = 271) from the first half of the second trimester (14 weeks of pregnancy) up to 24 weeks when pregnant women routinely evaluated regarding the GDM. During the 24-28 weeks of pregnancy, mothers were evaluated regarding the presence of GDM using a 75 g oral glucose tolerance test (OGTT). The fasting blood glucose (FBG) was also evaluated within OGTT processes. Each 500 mg probiotic capsule was a mixture of Lactobacillus acidophilus LA1 (>7.5 × 109 CFU), Bifidobacterium longum sp54 cs (>1.5 × 109 CFU), and Bifidobacterium bifidum sp9 cs (>6 × 109 CFU). RESULTS: Overall, 507 pregnant women make up our study population with a mean age of 32.03 years and a Body Mass Index (BMI) of 30.20 kg/m2. There was no significant difference between the intervention and the control group regarding FBG (88.68 vs. 89.61 mg/dL; P = 0.338), OGTT-1h (163.86 vs. 166.88; mg/dL; P = 0.116), and OGTT-2h (138.39 vs. 139.27; mg/dL; P = 0.599). The incidence of GDM in the intervention group was 41.9% which was not significantly different from the control group (40.2%) (P = 0.780). Likewise, no significant difference was detected in terms of other studied parameters. CONCLUSIONS: It seems that probiotics supplementation of pregnant women from the first half of the second trimester up to 24 weeks of pregnancy does not reduce the risk of GDM, or improve other neonatal and maternal outcomes.

The comparison of post-dural puncture headache treatment with acetaminophen-caffeine capsule and intravenous mannitol infusion: A randomized single-blind clinical trial.

Background: Post-dural puncture headache (PDPH) is a common problem after spinal anesthesia. Depending on the severity of PDPH, there are both invasive and non-invasive treatments. Caffeine has been used for the treatment of PDPH since 1949, but the administration of mannitol is a novel management to tackle PDPH. This study was conducted to compare the effectiveness of acetaminophen-caffeine and mannitol in the treatment of PDPH. Methods: We enrolled 80 patients with PDPH in the present clinical trial and observed them during 72 hours after cesarean section. Participants were randomly and equally allocated to two groups for treatment with intravenous (IV) mannitol or oral acetaminophen-caffeine. The effects of treatment were evaluated using the visual analogue scale (VAS) questionnaire at hours of 1, 2, 3, 4, 6, 12, 18, 24, and 48. SPSS software was used. Results: Forty patients in each group completed the study. There was a significant reduction in the pain scores of the both groups after treatment, but the interaction between time and group demonstrated that mannitol administration was superior to acetaminophen-caffeine in pain reduction of the patients undergoing spinal anesthesia (P = 0.028). Patients' satisfaction in the mannitol group was significantly higher than the caffeine group (P = 0.001). Conclusion: This study suggests that IV mannitol infusion affects faster and earlier for the treatment of PDPH than acetaminophen-caffeine capsule. Mannitol could be probably more effective for treatment of PDPH.

The comparison of anti-seizure and tocolytic effects of phenytoin and magnesium sulphate in the treatment of eclampsia and preeclampsia: A randomised clinical trial.

Background: To date, magnesium sulphate (MgSO4) is the treatment of choice for prevention of seizure in eclampsia and preeclampsia. However, there are some limitations in the administration of MgSO4 due to its tocolytic effects. The aim of this study was to compare the anticonvulsant and tocolytic effects of MgSO4 and another drug, phenytoin, in patients with eclampsia and preeclampsia. Methods: This clinical trial was conducted on pregnant women hospitalised with eclampsia or preeclampsia, during 2014-2016. The subjects were randomly assigned to two treatment groups using blocking method based on disease (eclampsia or mild and severe preeclampsia). One group received MgSO4 (group M) and another group received phenytoin (group P) as treatment. Each group consisted of 110 and 65 women with mild and severe preeclampsia, respectively (subgroup A), and 25 women with eclampsia (subgroup B). Duration of labor, the number of cesarean sections, convulsions and Apgar scores of infants were compared between the two groups and were considered as treatment outcomes. Results: Convulsion rate was significantly lower with MgSO4 than phenytoin (P = 0.001). No seizure occurred in patients with mild preeclampsia in group P. Duration of stage one of labor (P < 0.001) and the number of cesarean sections (P = 0.040) were significantly higher in group M. However, one-minute Apgar scores for newborns were higher in women treated with MgSO4 compared to that of phenytoin (P = 0.001). Five-minute Apgar was not significantly different. Conclusion: Although MgSO4 is more effective than phenytoin for prevention of convulsion in eclampsia and severe preeclampsia, phenytoin may be considered for treatment of special conditions such as mild preeclampsia. Due to the tocolytic effects of MgSO4 on increasing the duration of labor, the increased risk of cesarean section and the potential for toxicity, physicians should critically consider the best drug according to the condition of the patient.

Pulsed Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean Section: A Randomized, Double-Blind, Placebo-controlled Trial.

OBJECTIVES: To evaluate the efficacy of pulsed electromagnetic field (PEMF) in relation to reducing postoperative pain, analgesic use, and wound healing in patients undergoing Cesarean section (C-section). METHODS: This randomized, double-blind, placebo-controlled trial evaluated 72 women who underwent elective C-section. Thirty-six patients were assigned to the active-PEMF and 36 to the sham-PEMF groups. The participants were asked to report their pain intensity on a Visual Analog Scale (VAS) at 2, 4, 6, 12, and 24 hours and 2, 4, and 7 days after surgery. The amount of analgesics used was recorded. The surgical site was evaluated to assess the wound-healing process on the seventh postoperative day. RESULTS: Postoperative pain VAS scores were significantly lower in the active-PEMF group in all the measured periods within the early and the late postoperative periods. Fewer women in the active-PEMF group experienced severe postoperative pain within 24 hours postoperatively (36% vs. 72%, P=0.002). Analgesic use during the first 24 hours after C-section was 1.9-times lower in the active-PEMF group (1.6±0.7 vs. 3.1±1.2, P<0.001). The total analgesic use during the seventh postoperative days was 2.1-times lower in the active-PEMF group than in the sham group (1.7±0.7 vs. 3.7±1.1, P<0.001). Seven days postoperatively, patients in the active-PEMF group had better wound healing with no exudate, erythema, or edema (P=0.02). CONCLUSIONS: PEMF treatment after C-section decreases postsurgical pain, analgesic use, and surgical wound exudate and edema significantly, and is associated with a high level of patient satisfaction.

Sublingual misoprostol plus laminaria for cervical preparation before surgical management of late first trimester missed abortions, a randomized controlled trial.

OBJECTIVE: Comparing the efficacy of low-dose sublingual misoprostol plus laminaria to medium-dose sublingual misoprostol alone for cervical dilation before surgical management of late first trimester missed abortions. METHODS: Randomized, controlled trial evaluated 70 women with missed abortion, admitted for surgical termination of pregnancy. The patients were randomly assigned to receive 200 µg sublingual misoprostol with cervical laminaria (intervention group) or 400 µg sublingual misoprostol without laminaria (control group), four hours before surgical process. The study is registered at www.irct.ir (IRCT2014070711020N4). RESULTS: More patients in the intervention group achieved the desired cervical dilation (≥Hegar7) before surgical process than the control group (91.4% versus 17.1%, p < 0.001). Patients in the intervention group experienced less pain during the waiting period (mean Visual Analog Scale scores: 30.8 ± 3.7 versus 43.7 ± 5.9, p < 0.001), and had higher satisfaction level (highly satisfied: 97.1% versus 77.1%, p = 0.02). Four patients in the intervention group and none in the control group had spontaneous expulsion of pregnancy products (p = 0.11). CONCLUSIONS: Compared to medium-dose sublingual misoprostol alone, using a combination of cervical laminaria plus low-dose sublingual misoprostol before surgical process is associated with significantly more effective and rapid cervical dilation, lower requirement for mechanical dilation, lower abdominal pain and discomfort during the waiting period and higher patients' satisfaction.

Amlodipine and the Successful Management of Post-Electroconvulsive Therapy Agitation.

Electroconvulsive therapy (ECT) is a highly effective nonpharmacologic treatment for the management of depression and some other psychiatric disorders. Post-ECT agitation occurs in up to 12% of ECT treatments and is characterized by motor restlessness, irritability, disorientation, and panic-like behaviors. The severity of post-ECT agitation ranges from mild and self-limited to serious and severe forms requiring prompt medical intervention to protect the patient and the medical staff. In severe agitation medical management may be necessary which consists of using sedative agents, either benzodiazepines or propofol. The side-effects of these sedative agents, especially in the elderly population, necessitate finding ways that could help the prevention of the occurrence of agitation after ECT treatments. We report a 68-year-old female with major depression who was referred for ECT. She experienced severe post-ECT agitation requiring medical intervention after all ECT treatments. Administering of oral amlodipine (5 mg) one hour before ECT treatment successfully prevented the occurrence of post-ECT agitation in this patient. We briefly discuss the possible underlying mechanisms and pathophysiology of amlodipine in the prevention of post-ECT agitation.

The accuracy of placental alpha-microglobuline-1 test in diagnosis of premature rupture of the membranes.

BACKGROUND: Premature rupture of membranes (PROM) is a common obstetric issue during pregnancy which might lead to serious fetal or maternal problems. Therefore, an appropriate diagnosis and management of PROM are of significant importance in patients. OBJECTIVE: The aim of this study was to determine the accuracy of placental alpha microglobuline-1 (PAMG-1) test in PROM diagnosis and compare this diagnostic method with other standard tests in diagnosis of PROM. MATERIALS AND METHODS: In this prospective diagnostic accuracy study, patients with symptoms of membrane rupture in 16-39 weeks of gestation were involved. Three tests including Fern, Nitrazine and PAMG-1 were performed at the same time. RESULTS: PROM was confirmed in 86 patients out of 100. The sensitivity and specificity were respectively 81.3% and 100% for Fern test, 93% and 92.8% for Nitrazine test, 98.9% and 92.8% for PAMG-1 test. PAMG-1 test showed higher sensitivity (98.9% with p<0.001) and accuracy (98%) compared with conventional tests. Although PAMG-1showed a lower positive predictive value (PPV) compared to conventional tests such as Fern test (100%), it was shown to be more accurate. CONCLUSION: The accuracy of PAMG-1 test was superior to both Fern and Nitrazine test in PROM diagnosis.

The predictive value of ultrasound assessment of amniotic fluid index, biophysical profile score, nonstress test and foetal movement chart for meconium-stained amniotic fluid in prolonged pregnancies.

OBJECTIVE: To evaluate the value of non-stress test (NST), biophysical profile score (BPS), amniotic fluid index (AFI) and foetal movement charted (FMC) by mother in the prediction of meconium passage in post-date pregnancies. METHODS: In a cross-sectional study performed from 2003 to 2005, in the Ali-Ebne-Abitaleb Hospital, all post-date singleton pregnant women were included and evaluated a few hours before delivery for AFI, NST, BPS and FMC. Based on the results of the mentioned tests the occurrence of foetal distress was foreseen and the judgments were compared with the results of evaluation of the amniotic fluid after amniotomy during labour. Our judgment of occurrence of foetal distress was based on meconium staining of amniotic fluid (MSAF) as the gold standard. RESULTS: In this study 250 women were included. The sensitivity and specificity of these tests respectively were: 62% and 42% for NST, 66% and 56% for BPS, 38% and 83% for AFI and 44% and 64% for FMC. The highest positive predictive value was recorded respectively for AFI (52%) and negative predictive value was recorded for NST (94%). There was a significant association between MSAF and BPS. In univariate analyses, there was a significant association between MSAF and BPS (P = 0.010 for linear by linear association, exact method). Also there was a significant association between MSAF and AFI < 5 cm. (OR = 2.99, 95% CI, 1.57-5.74). CONCLUSION: Although BPS and AFI had the highest level of prediction, they are of limited usefulness in prediction of foetal distress. The reactive NST is more conclusive.

A comparison of tramadol and pethidine analgesia on the duration of labour: a randomised clinical trial.

BACKGROUND: The ideal obstetric analgesia should provide analgesic efficacy without attenuation of uterine contractions. AIMS: To compare the outcome of intramuscular administration of pethidine and tramadol in labour analgesia. METHODS: One hundred and sixty full-term parturients were randomly assigned to two equal groups in active labour. Group P received 50 mg pethidine; and group T, 100 mg tramadol intramuscularly. Primary outcome measure was the duration of the labour. The analgesic efficacy, maternal side-effects, mode of delivery, maternal satisfaction and Apgar score as the secondary outcome were assessed. RESULTS: The duration of labour was shorter in group T, for first stage (190 vs 140 min; P < 0.0001) and for second stage (33 vs 25 min; P = 0.001). There were no differences in Groups P and T with respect to median (7 vs 8) and maximum (7.5 vs 8) visual analog scores (VAS) for pain at 10 min and one hour after drug administration. Women in group P had lower VAS pain scores than those in group T in the second stage of labour (8 vs 9; P = 0/009). There was a significantly higher incidence of nausea and vomiting (35% vs 15%; P = 0.003) and drowsiness (80% vs 29%; P < 0.0001) in group P. CONCLUSION: Both 100 mg tramadol and 50 mg pethidine provide moderate analgesia in first stage of labour. Tramadol seems to cause a shorter duration of labour and lower incidence of maternal side-effects. However, its analgesic efficacy was not found to be as effective as pethidine, especially in the second stage of labour.

Prevention of nausea and vomiting in caesarean section under spinal anaesthesia with midazolam or metoclopramide?

OBJECTIVE: To evaluate the efficacy and safety of bolus dose of midazolam and metoclopramide in reducing emetic symptoms during caesarean delivery under spinal anaesthesia. METHODS: In a double-blind study, 80 women undergoing elective caesarean section under spinal anaesthesia (using 0.5% bupivacaine 10 mg) were allocated randomly to receive midazolam 2 mg, or metoclopramide 10 mg at the beginning of surgery before skin incision. The frequency of nausea and vomiting, sedative score, respiratory depression, and side effects were recorded. RESULTS: The frequency of intraoperative nausea and vomiting was lower in the midazolam group compared with metoclopramide (15% versus 52.5%). Sedation scores within 3 hour postoperatively were significantly lower in the metoclopramide group. The frequency of respiratory depression was higher in midazolam group. There were some episodes of respiratory depression (respiratory rate of less than 10 bpm) in 17 patients in the midazolam group at the time of surgery treated by verbal stimulation, but no respiratory depression was seen in metoclopramide group. Neonatal outcome was similar in the two groups and all the neonates had Apgar scores > or = 8 at one and five minutes. CONCLUSIONS: A bolus dose of midazolam (2 mg) was more effective than metoclopramide (10 mg) for the prevention of nausea and vomiting in parturients patients undergoing caesarean section under spinal anaesthesia, however, further studies are needed to prove the safety of midazolam in parturient patients undergoing caesarean section.