scholarly journals A double-blind randomised placebo-controlled trial of melatonin as an adjuvant agent in induction of labour (MILO): a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e032480
Author(s):  
Kamala Swarnamani ◽  
Miranda Davies-Tuck ◽  
Euan Wallace ◽  
Ben W Mol ◽  
Joanne Mockler
Keyword(s):  
Caesarean Section ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Caesarean Section Rate ◽  
Primary Outcome Measure ◽  
Induction Of Labour ◽  
Labour Induction ◽  
Double Blind ◽  
Vaginal Pessary ◽  
Estimated Blood Loss

IntroductionInduction of labour (IOL) is a common practice. In Australia, up to 40% of women undergoing labour induction will ultimately have a caesarean section. As a biological role for melatonin in the onset and progress of labour has been demonstrated, we aim to test the hypothesis that addition of melatonin will reduce the need for caesarean section.Methods and analysisThis is a double-blind, randomised, placebo-controlled trial in women undergoing IOL at term. We plan to randomise 722 women (1:1 ratio) to receive either melatonin (four doses of 10 mg melatonin: first dose—in the evening at the time of cervical balloon or Dinoprostone PGE2vaginal pessary insertion, second dose—at time of oxytocin infusion commencement, third dose—6 hours after the second dose, fourth dose—6 hours after the third dose) or placebo (same dosing regime). Participants who are having artificial rupture of the membranes only as the primary means of labour induction will receive up to three doses of the trial intervention. The primary outcome measure will be the requirement for a caesarean section. Secondary outcomes will include duration of each stage of labour and time from induction to birth, total dose of oxytocin administration, epidural rate, indication for caesarean section, rate of instrumental deliveries, birth within 24 hours of induction commencement, estimated blood loss, Apgar score at 5 min, neonatal intensive care unit admissions and participant satisfaction. Maternal melatonin levels will be measured immediately before commencement of the oxytocin intravenous infusion and 3 hours after and at the time of birth in order to determine any differences between the two trial arms.Ethics and disseminationThe study is conducted in accordance with the conditions of Monash Health HREC (RES-17-0000-168A). Findings from the trial will be disseminated through peer-reviewed publications and conference presentations.Protocol versionV.7.0, 30 July 2019.Trial registration numberACTRN12616000311459, Universal trial number: (UTN) U1111-1195-3515.

scholarly journals Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX): double blind randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n716
Author(s):  
Sidsel Boie ◽  
Julie Glavind ◽  
Niels Uldbjerg ◽  
Philip J Steer ◽  
Pinar Bor
Keyword(s):  
Caesarean Section ◽  
Fetal Heart Rate ◽  
Fetal Heart ◽  
Controlled Trial ◽  
Caesarean Section Rate ◽  
Active Phase ◽  
Double Blind ◽  
Oxytocin Infusion ◽  
Randomised Controlled ◽  
Reduced Risk

Abstract Objective To determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates. Design International multicentre, double blind, randomised controlled trial. Setting Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020. Participants 1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour. Intervention Women were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour. Main outcome measure Delivery by caesarean section. Results A total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155) in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups. Conclusions In a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns. Trial registration ClinicalTrials.gov NCT02553226 .

scholarly journals Induction of Labour in Growth Restricted and Small for Gestational Age Foetuses – A Historical Cohort Study

2019 ◽  
Vol 79 (04) ◽  
pp. 402-408
Author(s):  
Sven Kehl ◽  
Christel Weiss ◽  
Ulf Dammer ◽  
Sebastian Berlit ◽  
Thomas Große-Steffen ◽  
...  
Keyword(s):  
Cohort Study ◽  
Caesarean Section ◽  
Gestational Age ◽  
Small For Gestational Age ◽  
Caesarean Section Rate ◽  
Growth Restriction ◽  
Induction Of Labour ◽  
Labour Induction ◽  
Historical Cohort ◽  
Foetal Growth

Abstract Purpose Induction of labour for small-for-gestational-age (SGA) foetus or intrauterine growth restriction (IUGR) is common, but data are limited. The aim of this study was therefore to compare labour induction for SGA/IUGR with cases of normal foetal growth above the 10th percentile. Material and Methods This historical multicentre cohort study included singleton pregnancies at term. Labour induction for SGA/IUGR (IUGR group) was compared with cases of foetal growth above the 10th percentile (control group). Primary outcome measure was caesarean section rate. Results The caesarean section rate was not different between the 2 groups (27.0 vs. 26.2%, p = 0.9154). In the IUGR group, abnormal CTG was more common (30.8 vs. 21.9%, p = 0.0214), and foetal blood analysis was done more often (2.5 vs. 0.5%, p = 0.0261). There were more postpartum transfers to the NICU in the IUGR group (40.0 vs. 12.8%, p < 0.0001), too. Conclusion Induction of labour for foetal growth restriction was not associated with an increased rate of caesarean section.

scholarly journals A comparative study of misoprostol oral versus vaginal route for induction of labour

2020 ◽  
Vol 9 (5) ◽  
pp. 1907
Author(s):  
Apratim Mohan DebBarma ◽  
Jahar Lal Baidya ◽  
Debasis Ray
Keyword(s):  
Clinical Trial ◽  
Vaginal Delivery ◽  
Caesarean Section Rate ◽  
Induction Of Labour ◽  
Cervical Ripening ◽  
Labour Induction ◽  
Placebo Control ◽  
Vaginal Route ◽  
Double Blind ◽  
Outcome Differences

Background: Induction of labour at term is a common obstetric intervention. Prostaglandin E2 has been the agent of choice for pre-induction of cervical ripening for several decades. In recent time, prostaglandin E1 analogue (misoprostol) is a preferred new agent for pre-induction cervical ripening and labour induction owing to inexpensive, stable in room temperature, administrable through several routes. The ideal dose, route, and frequency of administration of misoprostol are still under investigation.Methods: A double blind parallel group placebo control randomized clinical trial was done in the department of obstetrics and gynecology of Agartala Govt. Medical College among 130 pregnant women those required induction of labour. In this clinical trial, the women were allocated by lottery to receive oral misoprostol (25 μg) and vaginal placebo (same dosage) or vaginal misoprostol (25 μg) and oral placebo (same dosage. Both active and placebo drug (25 mcg) were repeated at 4 hours. interval till the parturient reached active labour (not exceeding 5 doses). Both primary (induction delivery interval) and secondary outcomes (failed induction, vaginal/caesarean delivery rate, maternal and foetal complications) were statistically analyzed.Results: The mean induction delivery interval (primary outcome) differences were insignificant among both groups (oral versus vaginal). Success rate of induction (56.9% versus 75.4%), mean dosage (misoprostol 90.5 mcg versus 96 mcg) requirement, maternal and foetal complications was indifferent among two groups. The rate of vaginal delivery (within 24 hours of induction) was significantly higher when misoprostol was used through vaginal route. Caesarean section rate trends to be higher when misoprostol was administered orally.Conclusions: Low dose of misoprostol (25 mcg) offer an additional statistically significant clinical advantage in successful vaginal delivery when used vaginally.

scholarly journals Calcium plus vitamin D supplementation affects pregnancy outcomes in gestational diabetes: randomized, double-blind, placebo-controlled trial

2015 ◽  
Vol 19 (1) ◽  
pp. 156-163 ◽  
Author(s):  
Maryam Karamali ◽  
Zatollah Asemi ◽  
Maedeh Ahmadi-Dastjerdi ◽  
Ahmad Esmaillzadeh
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Caesarean Section ◽  
Gestational Diabetes ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Caesarean Section Rate ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Double Blind Placebo

AbstractObjectiveThe present study was designed to assess the effects of Ca+vitamin D supplementation on pregnancy outcomes in women with gestational diabetes mellitus (GDM).DesignA randomized, double-blind, placebo-controlled trial was conducted among sixty women with GDM. Participants were divided into two groups to receive Ca+vitamin D supplements or placebo. Individuals in the Ca+vitamin D group (n 30) received 1000 mg Ca/d and two pearls containing 1250 µg (50 000 IU) of cholecalciferol (vitamin D3) during the intervention (one at study baseline and another at day 21 of the intervention); those in the placebo group (n 30) received two placebos of vitamin D at the mentioned times and placebos of Ca every day for 6 weeks. Pregnancy outcomes were determined.SettingA urban community setting in Arak, Iran.SubjectsSixty women with GDM and their newborns, living in Arak, Iran were enrolled.ResultsWomen treated with Ca+vitamin D had a significant decrease in caesarean section rate (23·3 % v. 63·3 %, P=0·002) and maternal hospitalization (0 v. 13·3 %, P=0·03) compared with those receiving placebo. In addition, newborns of GDM women randomized to Ca+vitamin D had no case of macrosomia, while the prevalence of macrosomia among those randomized to placebo was 13·3 % (P=0·03). Lower rates of hyperbilirubinaemia (20·0 % v. 56·7 %, P=0·03) and hospitalization (20·0 % v. 56·7 %, P=0·03) were also seen in the supplemented group of newborns than in the placebo group.ConclusionsCa+vitamin D supplementation for 6 weeks among pregnant women with GDM led to decreased caesarean section rate and maternal hospitalization, and decreased macrosomia, hyperbilirubinaemia and hospitalization in newborns.

scholarly journals Indications for labour induction and predictors for failed induction at KMCTH

1970 ◽  
Vol 7 (1) ◽  
pp. 21-25 ◽  
Author(s):  
RT Rayamajhi ◽  
C Karki ◽  
N Shrestha ◽  
SM Padhye
Keyword(s):  
Birth Weight ◽  
Caesarean Section ◽  
Failure Rate ◽  
Caesarean Section Rate ◽  
Induction Of Labour ◽  
Labour Induction ◽  
Operative Delivery ◽  
Bishop Score ◽  
Obese Women ◽  
Failed Induction

Objective: To study the incidence and indications for labour induction and study the predictors of failed induction. Materials and methods: A hospital based prospective study done over a 12 month period between 1st November 2007 to 30th October 2008. Selection criteria: Singleton pregnancies beyond 37 weeks with vertex presentation and unscarred uterus requiring induction of labour. Results: The incidence of labour induction was 19.7%. Operative delivery was 34.6% in the study group and 27.4% in those with spontaneous onset of labour. 74.07% of the induction group required operative delivery for failed induction and 25.03% for foetal distress. The predominant indication for induction was post term pregnancy (51.28%) followed by PROM (17.3%), isolated oligohydramnios (8.97%), hypertensive disorders of pregnancy (8.33%), maternal perception of decreased foetal movements (7.69%) and others. Failed induction was higher in nulliparas (41.2%) as compared to multiparas (23.7%). Failure rate was 53.8% when maternal age >30y and 28.2% in those < 30y. Women with normal BMI had a failure rate of 25.6% compared to 36% for overweight and 44.4% for obese women. 24.1% had failed induction when Bishop score was >5 and 40.8% when Bishop score was < 5. Between 38-41 weeks pregnancy failed induction occurred in 28-31% while it was higher at 41 weeks pregnancy. The best outcome was seen when the birth weight was 2500-2900g (22.5% failures) while 72.7% had failed induction when the birth weight was >3500g. The duration of induction was >24 hours in 42.6% of women and 48.2% were in the latent phase of labour when taken for caesarean section. Conclusion: Despite the proven benefit of induction of labour in selected cases, one must keep in mind its impact on increasing the rates of operative delivery. Strategies for developing practice guidelines may help to prevent unwarranted case selection and help to reduce the current high operative delivery rates. Key words: caesarean section rate, failed induction, induction of labour. doi: 10.3126/kumj.v7i1.1760       Kathmandu University Medical Journal (2009), Vol. 7, No. 1, Issue 25, 21-25    

scholarly journals Validation of the pediatric refractory septic shock definition: post hoc analysis of a controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Luc Morin ◽  
Karthik Narayanan Ramaswamy ◽  
Muralidharan Jayashree ◽  
Arun Bansal ◽  
Karthi Nallasamy ◽  
...  
Keyword(s):  
Septic Shock ◽  
Intensive Care ◽  
Neonatal Intensive Care ◽  
Controlled Trial ◽  
Receiver Operating Curve ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Prognostic Accuracy ◽  
Refractory Septic Shock ◽  
Post Hoc

Abstract Background The European Society of Pediatric and Neonatal Intensive Care (ESPNIC) developed and validated a definition of pediatric refractory septic shock (RSS), based on two septic shock scores (SSS). Both bedside SSS (bSSS) and computed SSS (cSSS) were found to be strongly associated with mortality. We aimed at assessing the accuracy of the RSS definition on a prospective cohort from India. Methods Post hoc analysis of a cohort issued from a double-blind randomized trial that compared first-line vasoactive drugs in children with septic shock. Sequential bSSS and cSSS from 60 children (single-center study, 53% mortality) were analyzed. The prognostic value of the ESPNIC RSS definition was tested for 28-day all-cause mortality. Results In this septic shock cohort, RSS was diagnosed in 35 patients (58.3%) during the first 24 h. Death occurred in 30 RSS patients (85.7% mortality) and in 2 non-RSS patients (8% mortality), OR = 60.9 [95% CI: 10.5–676.2], p < 0.001 with a median delay from sepsis onset of 3 days [1.0–6.7]. Among patients diagnosed with RSS, the mortality was not significantly different according to vasopressors randomization. Diagnosis of RSS with bSSS and cSSS had a high discrimination for death with an area under the receiver operating curve of 0.916 [95% CI: 0.843–0.990] and 0.925 [95% CI: 0.845–1.000], respectively. High prognostic accuracy of the bSSS was found in the first hours following intensive care admission. The best interval of prognostication occurs after the 12th hour following treatment initiation (AUC 0.973 [95% CI: 0.925–1.000]). Conclusions The ESPNIC refractory septic shock definition accurately identifies, within the first 6 h of septic shock management, children with lethal outcome.

scholarly journals Randomised Double-Blind Trial of Combination Antibiotic Therapy in Rheumatoid Arthritis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Angela Smith ◽  
Caroline Doré ◽  
Peter Charles ◽  
Alena Vallance ◽  
Tara Potier ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Placebo Group ◽  
Active Treatment ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Good Evidence ◽  
Double Blind ◽  
Acr20 Response ◽  
Significant Difference

Objective. A combination of intravenous clindamycin and oral tetracycline has been used for many years as a treatment for active rheumatoid arthritis (RA), despite the absence of good evidence for its efficacy. A single-blind pilot study of this therapy suggested that a double-blind placebo-controlled trial was warranted.Methods. Patients with active RA were randomised in a 2 : 1 ratio to receive active treatment or placebo for 25 weeks. The active treatment consisted of intravenous clindamycin in a reducing regime, and oral tetracycline twice daily three times a week. 50 patients were to be recruited. The primary outcome measure was the proportion of patients achieving an ACR20 response.Results. An interim statistical analysis was performed after 20 patients had completed the study. Two patients in the active group achieved an ACR20 response, with none in the placebo group (NS). There was a better ESR20 response in the placebo group (P=.02). There were no other significant differences between the groups. The results indicated that it was unlikely that a significant difference in ACR20 response would emerge if the remaining 30 patients were recruited. The trial was therefore halted.Conclusion. This antibiotic regime is unlikely to be a valuable therapy for active rheumatoid arthritis.

The Efficacy of Nebulized Budesonide in Dexamethasone-treated Outpatients With Croup

PEDIATRICS ◽  
1996 ◽  
Vol 97 (4) ◽  
pp. 463-466
Author(s):  
Terry P. Klassen ◽  
Lise K. Watters ◽  
Mark E. Feldman ◽  
Teresa Sutcliffe ◽  
Peter C. Rowe
Keyword(s):  
Controlled Trial ◽  
Tertiary Care ◽  
Airway Disease ◽  
Primary Outcome Measure ◽  
Lower Airway ◽  
Inspiratory Stridor ◽  
Double Blind ◽  
Oral Dexamethasone ◽  
Number Of Patients ◽  
Pediatric Outpatients

Objective. To determine the added clinical benefit of nebulized budesonide in children with mild to moderate croup treated with 0.6 mg/kg oral dexamethasone. Design. Randomized, double-blind, placebo-controlled trial. Setting. Emergency department of a tertiary-care pediatric hospital with 47 000 visits per year. Participants. Children 3 months to 5 years of age with a syndrome consisting of hoarseness, inspiratory stridor, and barking cough and a croup score of 3 or greater after at least 15 minutes of mist therapy. Patients were excluded from the study if they had diagnoses of epiglottitis, chronic upper or lower airway disease (not including asthma), or severe croup or had received corticosteroids within the preceding 2 weeks. Intervention. All patients received 0.6 mg/kg oral dexamethasone and were randomly assigned to receive 4 mL (2 mg) of budesonide solution (n = 25) or 4 mL of 0.9% saline solution (n = 25) by updraft nebulizer with a continuous flow of oxygen at 5 to 6 L/min. Main Outcome Measures. The primary outcome measure was the proportion of patients in each group who had clinically important changes (two points) in the croup score during the 4 hours after treatment. Results. Eighty-four percent (n = 21) of the patients who received budesonide had clinically important responses, compared with 56% (n = 14) in the placebo group. The number of patients who would need to be treated with nebulized budesonide for one patient to have a clinically important response is four patients. Conclusions. Despite receiving simultaneous oral dexamethasone, pediatric outpatients with mild to moderate croup have added, clinically important improvement in respiratory symptoms after treatment with budesonide.

scholarly journals A comparative study of intra-cervical foley’s catheter and PGE2 gel for induction of labour at term

2019 ◽  
Vol 8 (9) ◽  
pp. 3689
Author(s):  
Anjali R. Kanada ◽  
Mahima Jain
Keyword(s):  
Side Effects ◽  
Caesarean Section ◽  
Comparative Study ◽  
Foley Catheter ◽  
Induction Of Labour ◽  
Cervical Ripening ◽  
Labour Induction ◽  
Mechanical Methods ◽  
Significant Difference ◽  
Foley’S Catheter

Background: In cervical ripening, before induction of labour, is needed to increase the success of labour induction, to reduce complications and to diminish the rate of caesarean section and duration of labour. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley’s catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, the study has been conducted to prove the efficacy and safety of extra amniotic Foley catheter balloon and to compare it with intra-cervical prostaglandin E2 (PGE2) gel. The objective of the study was to the success of induction of labor depends on the cervical status at the time of induction. For effective cervical ripening both Foley's catheter and PGE2 gel are used. The aim of this study was to compare the efficacy of intra cervical Foley's catheter and intra cervical PGE2 gel in cervical ripening for the successful induction of labor.Methods: A randomized, comparative study was conducted in the department of obstetrics and gynaecology, Civil hospital, B.J. Medical College Ahmedabad, during a period of 8 month from September 2018 to April 2019. 100 patients at term with a Bishop's score ≤5 with various indications for induction were randomly allocated to group F (intra-cervical Foley’s catheter) and group P (PGE2 gel) with 50 women included in each group.Results: The groups were comparable with respect to maternal age, gestation age, indication of induction and initial Bishop's score. Both the groups showed significant change in the Bishop's score, 5.10±1.55 and 5.14±1.60 for Foley's catheter and PGE2 gel, respectively, p <0.001. However there was no significant difference between the two groups. There was no significant difference in the side effects and caesarean section rate in both groups. The induction to delivery interval was 16.01±5.50 hours in group F and 16.85 ± 3.81 hours in group P (p=0.073). Apgar scores, birth weights and NICU admissions showed no significant difference between the two groups.Conclusions: The study shows that both Foley's catheter and PGE2 gel are equally effective in pre induction cervical ripening.

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