Effectiveness and Safety of Isoxsuprine Hydrochloride as Tocolytic Agent in Arresting Active/Threatened Preterm Labor and Its Role in Maintenance Tocolysis—A Prospective, Open-Label Study

Author(s):  
Purushottam B. Jaju

Abstract Objective The aim of the study is to obtain insights on the short and long-term safety and effectiveness of isoxsuprine hydrochloride as a tocolytic agent in the management of PTL. Study Design In this prospective, single-center, noncomparative study, patients (with preterm labor at gestational age of 24–37 weeks) were administered intravenous (IV) infusion of 40-mg isoxsuprine hydrochloride until uterine quiescence, followed by intramuscular (IM) injection of isoxsuprine hydrochloride 10 mg/4-hourly for first 24 hours and maintained with retard 40-mg sustained release capsule (two times a day) till the time of delivery or 37 completed weeks of pregnancy. Results All patients (n = 50) achieved successful tocolysis in 24 hours and 48 hours postadministration of isoxsuprine hydrochloride (IV/IM/oral). Mean (±SD) gestation age at the time of delivery was 39.8 ± 2.1 weeks, with latency period of 58.5 ± 18.7 days. Pregnancy outcomes were normal in all the patients and no congenital anomaly/fetal infection was reported. Mean (±SD) fetal birth weight was 2.7 ± 0.3 kg; mean (±SD) Apgar score at 1 and 5 minutes were 7.5 ± 0.6 and 9.2 ± 0.4, respectively. Maternal tachycardia and vomiting (8.0% each) were the commonly reported adverse drug reactions, which were resolved with dose adjustment. Conclusion Isoxsuprine was found to be an effective and well-tolerated tocolytic agent in arresting PTL, in turn resulting in the overall improvement in maternal and perinatal outcomes.

2014 ◽  
Vol 34 (1) ◽  
pp. 44
Author(s):  
C. Roos ◽  
M.E. Spaanderman ◽  
E. Schuit ◽  
K.W. Bloemenkamp ◽  
A.C. Bolte ◽  
...  

JAMA ◽  
2013 ◽  
Vol 309 (1) ◽  
pp. 41 ◽  
Author(s):  
Carolien Roos ◽  
Marc E. A. Spaanderman ◽  
Ewoud Schuit ◽  
Kitty W. M. Bloemenkamp ◽  
Antoinette C. Bolte ◽  
...  

2015 ◽  
Vol 64 (5) ◽  
pp. 48-54
Author(s):  
Kristina Albertovna Oganyan ◽  
Ol’ga Nikolaevna Arzhanova ◽  
Svetlana L’vovna Zatsiorskaya ◽  
Alevtina Mikhailovna Savicheva

Enterococcus are opportunistic bacteria and are members of the normal microflora of the gastrointestinal tract of humans and animals. The prevalence of enterococcal infections in pregnant women is approximately 28 %. Enterococcus, colonizing the urogenital tract pregnant women mostly do not show pathogenic effect, however, it is known that they can lead to the development of such complications of pregnancy as threatened preterm labor, placental insufficiency, hypotrophy of the fetus. Of complications in childbirth most common in premature labor, untimely discharge of amniotic fluid, fetal hypoxia. According to the literature cause of neonatal bacteremia and sepsis in 10 % of cases are enterococcus. Thus, for the prevention of complications of pregnancy, delivery and perinatal outcomes in the allocation of Enterococcus urogenital tract to undergo antibacterial therapy, given the sensitivity to antibiotics.


Author(s):  
P. B. Jaju ◽  
Abha Sood ◽  
Vaishali Chavan ◽  
Geetanjali Devgarha ◽  
Seema Jain ◽  
...  

Background: Preterm labor (PTL) is considered as one of the leading cause of perinatal morbidity and mortality. Preterm labor refers to the onset of uterine contractions of sufficient strength and frequency to effect progressive dilatation and effacement of cervix between 22 and 37 weeks of gestation.Methods: In this study, 285 patients of PTL admitted/treated (during the period of 1st January 2014 to 31st December 2016) across 5 centres in India were enrolled. Adult women with PTL, receiving oral or intravenous regime of tocolytic drugs were screened based on eligibility criteria.Results: We evaluated the practice patterns in the management of PTL in India. The pharmacological management (n=193) was preferred over nonpharmacological management (n=92) in the present study. Amongst the pharmacological agents, isoxsuprine (60.10%) was more frequently used followed by nifedipine (23.83%). Prolongation of delivery for at least 48 hours was observed in 57.76% patients receiving isoxsuprine compared to 34.78% patients receiving nifedipine. The mean latency period (36.77±28.09 vs. 1.44±1.33 days), birthweight (2.25±1.34 vs. 1.07±0.34 kg) and Apgar score at 5 mins (7.56±2.36 vs. 4.87±2.10) was higher for isoxsuprine compared to nifedipine group patients, with mean gestational age of <32 weeks (extreme to very PTL cases; p<0.0001). Similar results were observed in latency period and Apgar score between isoxsuprine and nifedipine groups in late PTL cases (>32 weeks).Conclusions: Pharmacological treatment was preferred for the management of PTL in India. Among pharmacological agents, isoxsuprine was preferred over other tocolytics. Significant improvement in mean latency period, prolongation of delivery beyond 48 hours and perinatal outcomes were noted amongst patients on isoxsuprine versus other pharmacological agents.


2021 ◽  
Vol 104 (5) ◽  
pp. 746-756

Background: Progesterone has established roles in preventing preterm labor in women with history of spontaneous preterm labor and short cervix, but there is little evidence to support its use to prevent preterm delivery in women with threatened preterm labor. Objective: To evaluate clinical efficacy of oral and vaginal progesterone on prevention of preterm delivery before 34 and 37 weeks in threatened preterm labor. Materials and Methods: The present study was a 3-arm randomized control trial, 231 singleton pregnancies of 28- to 33-weeks-6-days who had threatened preterm labor were recruited and randomized to three groups,1) 200 mg/day vaginal micronized progesterone, 2) 30 mg/day oral dydrogesterone and 3) control group with no progesterone. All groups received identical standard treatment for threatened preterm labor. Comparison of primary outcomes, which is the preterm delivery before 34 and 37 weeks, across groups were performed using chi-square test. Secondary outcomes, which are latency period, cervical change, maternal morbidity, neonatal morbidity, and mortality, were also compared. Results: Proportion of preterm delivery before 34 weeks was not significantly different across the three treatment groups at 16.0%, 12.0%, and 5.2% in control, oral progesterone, and vaginal progesterone groups, respectively (p=0.098). Concerning pairwise comparison, vaginal progesterone was more efficacious in preventing preterm delivery before 34 weeks than the control group (p=0.030), while oral progesterone was similarly effective to the control group (p=0.638). Proportion of preterm delivery before 37 weeks was not significantly different across the three treatment groups at 41.3%, 45.3%, and 31.2% in control, oral, and vaginal progesterone groups, respectively (p=0.182). Latency period differed across three treatment groups with a median latency of 36.5, 42.0, and 43.0 days in control, oral, and vaginal progesterone groups, respectively (p=0.041). Changes in cervical length and Bishop scores were not different across treatment groups. Conclusion: Vaginal progesterone could prevent preterm delivery before 34 weeks and prolong latency period in women with threatened preterm labor. Keywords: Preterm labor, Progesterone efficacy, Threatened preterm labor, After tocolysis


2013 ◽  
Vol 68 (5) ◽  
pp. 342-344
Author(s):  
Carolien Roos ◽  
Marc E. A. Spaanderman ◽  
Ewoud Schuit ◽  
Kitty W. M. Bloemenkamp ◽  
Antoinette C. Bolte ◽  
...  

Author(s):  
Bhupesh Dewan ◽  
Sanjaykumar Navale ◽  
Siddheshwar Shinde

Aims: To assess the efficacy and fetomaternal safety of atosiban among Indian pregnant women presenting with preterm labor. Study Design: Prospective, open-label, multicentric, non-comparative, phase-IV clinical study. Place and Duration of Study: Department of Obstetrics and Gynaecology at nine hospitals across India from October 2016 to December 2019. Methodology: A total of 212 pregnant women admitted with preterm labour between 24 and 36 weeks of gestation were administered intravenous atosiban up to 48 hours. Efficacy was defined as the successful delay of delivery without the need of an additional or alternative tocolytic agent for 72 hours. Safety was evaluated by recording the occurrence of adverse events in the mother, fetus and neonate. Results: Tocolytic efficacy of Atosiban was 84.88% at 48 hours and 74.15% at day 7 without additional tocolytic agent or retreatment after 48 hours. The mean number of days gained after the start of atosiban tocolysis were 29.15 ± 1.82 days with mean gestational age at delivery of 35.1 ± 3.33 weeks. Atosiban reduced the frequency of contractions from 4.3 ± 1.47 to 0.67 ± 1.13 contractions/30 min at 72 hours. The proportion of neonates with birth weights more than 2,500 gm was 41.67%. A total of 205 neonates out of 216 (94.95%) had APGAR score more than 7 after 5 minute. Atosiban successfully delayed the labour in 92.31% (n=13) of “Twin pregnancy” patients for 48 hours and beyond 7 days in 9 patients (69.2%). There were no serious adverse events reported. Conclusions: In patients with threatened preterm birth, 48 hour tocolysis with atosiban was found to be safe and effective in preventing imminent preterm birth even when it was a twin pregnancy or associated with co-morbidities. Atosiban showed favorable side effects profile and improved the perinatal outcomes. Clinical Trial Registry of India Number: CTRI/2017/03/008065;


2018 ◽  
Vol 2018 ◽  
pp. 1-4 ◽  
Author(s):  
Nikolina P. Docheva ◽  
Emily D. Slutsky ◽  
Roger Sandelin ◽  
James W. Van Hook

Calcium channel blockers are commonly used tocolytic agents on Labor and Delivery units worldwide as part of the management of preterm labor. Despite their overall reassuring safety profile, rare cardiovascular complications have been reported. In this report, we describe the case of threatened preterm labor managed with nifedipine with subsequent development of atrial fibrillation. This type of cardiac arrhythmia may have considerable consequences for both the mother and the fetus. The aim of this case report and comprehensive review of the literature is to raise awareness.


Sensors ◽  
2021 ◽  
Vol 21 (7) ◽  
pp. 2496
Author(s):  
Gema Prats-Boluda ◽  
Julio Pastor-Tronch ◽  
Javier Garcia-Casado ◽  
Rogelio Monfort-Ortíz ◽  
Alfredo Perales Marín ◽  
...  

Preterm birth is the leading cause of death in newborns and the survivors are prone to health complications. Threatened preterm labor (TPL) is the most common cause of hospitalization in the second half of pregnancy. The current methods used in clinical practice to diagnose preterm labor, the Bishop score or cervical length, have high negative predictive values but not positive ones. In this work we analyzed the performance of computationally efficient classification algorithms, based on electrohysterographic recordings (EHG), such as random forest (RF), extreme learning machine (ELM) and K-nearest neighbors (KNN) for imminent labor (<7 days) prediction in women with TPL, using the 50th or 10th–90th percentiles of temporal, spectral and nonlinear EHG parameters with and without obstetric data inputs. Two criteria were assessed for the classifier design: F1-score and sensitivity. RFF1_2 and ELMF1_2 provided the highest F1-score values in the validation dataset, (88.17 ± 8.34% and 90.2 ± 4.43%) with the 50th percentile of EHG and obstetric inputs. ELMF1_2 outperformed RFF1_2 in sensitivity, being similar to those of ELMSens (sensitivity optimization). The 10th–90th percentiles did not provide a significant improvement over the 50th percentile. KNN performance was highly sensitive to the input dataset, with a high generalization capability.


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