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 Bayes Theorem and Protopathic Bias: Methodological Concerns When Addressing the Impact of Fetal Heart Rate Patterns on the Cesarean Section Rate

2020 ◽  
Vol 10 (03) ◽  
pp. e342-e345
Author(s):  
Jacques Balayla ◽  
Ariane Lasry ◽  
Yaron Gil ◽  
Alexander Volodarsky-Perel
Keyword(s):  
Heart Rate ◽  
Caesarean Section ◽  
Fetal Heart Rate ◽  
Predictive Power ◽  
Fetal Heart ◽  
Caesarean Section Rate ◽  
Bayes Theorem ◽  
The Poor ◽  
Clinical Scenarios ◽  
The Impact

AbstractOver the last 30 years, the caesarean section rate has reached global epidemic proportions. This trend is driven by multiple factors, an important one of which is the use and inconsistent interpretation of the electronic fetal monitoring (EFM) system. Despite its introduction in the 1960s, the EFM has not definitively improved neonatal outcomes, yet it has since significantly contributed to a seven-fold increase in the caesarean section rate. As we attempt to reduce the caesarean rates in the developed world, we should consider focusing on areas that have garnered little attention in the literature, such as physician sensitization to the poor predictive power of the EFM and the research method biases that are involved in studying the abnormal heart rate patterns—umbilical cord pH relationship. Herein, we apply Bayes theorem to different clinical scenarios to illustrate the poor predictive power of the EFM, as well as shed light on the principle of protopathic bias, which affects the classification of research outcomes among studies addressing the effects of the EFM on caesarean rates. We propose and discuss potential solutions to the aforementioned considerations, which include the re-examination of guidelines with which we interpret fetal heart rate patterns and the development of noninvasive technologies that evaluate fetal pH in real time.

scholarly journals Computerised interpretation of fetal heart rate during labour (INFANT): a randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 389 (10080) ◽  
pp. 1719-1729 ◽  
Author(s):  
Peter Brocklehurst ◽  
David Field ◽  
Keith Greene ◽  
Ed Juszczak ◽  
Robert Keith ◽  
...  
Keyword(s):  
Heart Rate ◽  
Randomised Controlled Trial ◽  
Fetal Heart Rate ◽  
Fetal Heart ◽  
Controlled Trial ◽  
Randomised Controlled

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 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.

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