scholarly journals Efficacy and safety of oral mifepristone for cervical priming and induction of labor in term pregnancy

Author(s):  
Abhilasha Gupta ◽  
Aruna Verma ◽  
Iti Madan ◽  
Monika Kashyap

Background: The objectives of the study was to assess the efficacy of mifepristone in priming the cervix/inducing labor over next 96 hrs in term pregnancy.Methods: In this single blind randomized controlled trial 200 women with term pregnancy beyond 39 weeks and Bishop’ score <6 were randomly allocated into two groups. Tab Mifepristone 400 mg orally was given to women in study group (n=100) and no intervention in control group (n=100). On follow up one case was lost in control group. All women were observed for change in the bishop’s score or onset of labor in next 96 hrs. If Bishop’s score was <6, the choice of induction was left on the clinician/patient.Results: Mean induction to delivery interval, duration of active phase and improved Bishop score were 79.35±53.43 hr, 2.47±1.23 hr, 6.68±1.69 for study group versus 148±65.66 hr, 3.09±1.45 hr, 5.8±2.15  for control group (p value is <0.001) respectively.  Seventy one (71%) women in study group and 39 (39.3%) women in control group delivered vaginally within 96 hrs without any need of augmentation. There were 9 (9%) caesareans in study group and 24 (24.2%) caesareans in control group but no instrumental delivery in both groups. There was no statistically difference in perinatal outcomes between two groups.Conclusions: Mifepristone is an effective drug for cervical ripening and initiation of labor when given in term pregnancy beyond 39 weeks with poor Bishop’s score (<6) and appearing to reduce need for other agent for augmentation of labor.

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 463
Author(s):  
Mar Gomis-Pastor ◽  
Sonia Mirabet Perez ◽  
Eulalia Roig Minguell ◽  
Vicenç Brossa Loidi ◽  
Laura Lopez Lopez ◽  
...  

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.


Author(s):  
LICIA SANTANA ◽  
Rubneide Gallo ◽  
Silvana Quintana ◽  
Geraldo Duarte ◽  
Cristine Homsi Ferreira ◽  
...  

Objective: To evaluate the effectiveness of a non-pharmacological childbirth care protocol in women in the active phase of labour in improving obstetric and perinatal outcomes. Design: Randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting: Reference Centre of Women’s Health of Ribeirão Preto–MATER, São Paulo, Brazil. Methods: Eighty low-risk primiparous women at the end of pregnancy and beginning of the active phase of labour were randomized to experimental group (EG) (n=40) or control group (CG) (n=40). Women in EG received four interventions: ambulation at 4 to 6 cm of cervical dilation; alternative maternal positions associated with TENS at 6 to 7 cm, and a warm shower bath at >7 cm. The CG received only routine obstetric. Main outcome measures: The length of the active phase of labour, the expulsive phase duration, and the prevalence of labour dystocia assessed by the partograph. Results: The parturients who received the sequential non-pharmacological protocol had a shorter length of the active phase of labour (CG=444 minutes; EG=373 minutes; p=0,02), presented rupture of membranes later in labour (CG=7cm; EG=8cm; p<0,01), requested pharmacological analgesia with more significant cervical dilatation (CG=5cm; EG=8cm; p<0,01) and had lower labour dystocia rates than the patients in the CG. Conclusion: The implementation of a sequential non-pharmacological protocol has the potential in decreased and delayed use of pharmacological analgesia, duration of the active phase of labour and dystocia rates. Keywords: length of labour, labour pain, dystocia, randomized controlled trial, non-pharmacological resources, pharmacological analgesia. Trial registration: NCT01601860 Link: https://clinicaltrials.gov/ct2/show/NCT01601860


Author(s):  
Uma H. Chourasia ◽  
Mudita Kamlesh Jain ◽  
Juzar I. Fidvi

Background: Planned induction of labor is an established part of modern obstetrics and is used as a definite form of treatment where continuation of pregnancy would be detrimental to the health of mother or fetus. The objective of this study was to evaluate the effect of mifepristone in pre-induction cervical ripening and labor induction.Methods: A total of 200 pregnant women at term with Bishop Score 4 or less were selected for this prospective randomized placebo-controlled study. The sample was equally divided into study group to receive 200 mg of mifepristone and control group to receive placebo orally for 2 days. Bishop score was assessed at every 24 hours interval till patient entered in spontaneous labor or 72 hours after 1st dose. Women who did not enter labor spontaneously, labor induction was planned with per vaginal insertion of prostaglandin (PG) E2 analogue, Dinoprostone gel 2.5 mg or PGE1 analogue Tab. Misoprostol 25 µg.Results: Ninety-six subjects in the study group and eighty-one in the control achieved successful ripening of cervix and the difference was statistically significant. Sixty-eight of study group and thirty-nine of placebo group entered in spontaneous active labor within 72 hours. Requirement of oxytocin as adjuvant treatment was significantly lower in the study group. Nineteen women of study group and fifteen of control group delivered within 24 hours, and eighty-one of study group and sixty-two of placebo delivered in 48 hours. The mean induction delivery interval was 35.53±13.67 hours in the study group, whereas it was significantly prolonged in the placebo group 50.49±20.92 hours. Eighty-two subjects of study group and seventy-eight of the control group delivered vaginally, the differences were statistically not significant.Conclusions: Mifepristone was found to be an effective agent for cervical priming prior to labor induction in women at term and significantly reduces the induction delivery interval compared with placebo.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Mohamed Mahmoud Salman ◽  
Fekria Ahmed Salama ◽  
Mina Yacoub

Abstract Background Induction of labor is one of the most common procedures performed in the world of Obstetrics. Traditionally, labor induction is performed using prostaglandin and oxytocin. However, usage of corticosteroids nowadays is gaining a lot of interest regarding its effects on cervical ripening and shortening the physiological process of labor. Aim of work to evaluate the efficacy of intravenous dexamethasone versus vaginal misoprostol in enhancing cervical ripening and labor induction. Patients and Methods A randomized controlled clinical trial was carried out at Ain Shams University Maternity Hospital on (60) full term pregnant women between 39 – 42 weeks undergoing induction of labor, during a period from April 01, 2019 to November 30, 2019. Pregnant women were divided into two groups; vaginal misoprostol (control) group and intravenous dexamethasone (experimental) group (30 cases each). Results Our study showed that the mean time interval (hours) from initiation of labor induction to initiation of active phase was statistically significantly shorter among the dexamethasone (experimental) group 7.36 ± 2.23 versus 12.20 ± 4.92 hours among the vaginal misoprostol (control) group (p value &lt; 0.001). Also, the mean time interval of the total duration between the induction of labor to successful vaginal delivery was statistically significantly shorter among the dexamethasone group 10.90 ± 4.17 versus 19.20 ± 5.62 hours among the vaginal misoprostol group (p value &lt; 0.001). The results of this study showed the rate of initiation of active phase and rate of successful vaginal delivery were more in the experimental dexamethasone group than the control vaginal misoprostol control group. Conclusion Intravenous injection of 8 mg of dexamethasone before induction of labor is found to shorten the duration of labor induction by reducing the time interval between the initiation of labor induction and onset of active phase and the total duration from initiation of labor induction to delivery with no marked maternal or fetal complications. Recommendations Intravenous Dexamethasone can help cervical ripening and accelerate induction of labor. Further research should be taken in consideration with more population for more global evaluation.


Author(s):  
Panya Sananpanichkul, MD ◽  
Chatchai Sawadhichai, MD, PhD ◽  
Yosapon Leaungsomnapa, PhD ◽  
Paweena Yapanya, BATM

Background and Objectives: Court-type Thai traditional Massage (c-TTM) applied during intrapartum may have some benefit other than pain relief. This study aimed to evaluate the effect of c-TTM during the first and second stage of labor, as well as pain alleviation in the first stage.Methods: This was a randomized controlled trial study. Eligible participants were singleton pregnant mothers with cervical dilation between 3–5 cm and no medical complications. Both trial groups received the same routine antepartum care except for 1 hour additional c-TTM given to the experimental group when they were in the active phase of labor. The pain score was taken from the participants at the time before labor pains started, at the time of active labor, 1, 2, 3, and 4 hours after the intervention. Pain was recorded by the researcher using a visual analog scale. The primary outcome during the first and second stages of labor was compared between groups. Pain relief during the first stage of labor and analgesic drugs used were compared as a secondary outcome. This trial is registered under the identification number TCTR20171115003.Results: Fifty-nine participants were enrolled and randomly assigned with 1:1 allocation to groups. The duration of first and second stage labor was significantly shorter in the experimental c-TTM than in the conventional control group (mean ± SD: 198.37 ± 62.80 minutes: 268.52 ± 137.81 minutes, p value =.02 and 17.54 ± 9.49 minutes: 23.35 ± 15.01 minutes, p value =.03, re-spectively). There was no difference of pain score between the groups.Conclusion: One hour of c-TTM can signifi-cantly decrease the duration of the first and second stages of labor. The pain score recorded is not statistically different between the groups.


2018 ◽  
Vol 6 (3) ◽  
pp. 90-95
Author(s):  
Rosina Manandhar ◽  
Rachana Saha ◽  
Junu Bajracharya ◽  
Rumina Malla

Background: Induction of labour is one of the most important interventions done in modern obstetric practice and the success of induction techniques depends upon its role in cervical ripening and improvement in the Bishop’s score.Objectives: This study was done to compare the improvement in Bishop’s score among the women receiving oral mifepristone and oxytocin infusion to ripen the cervix prior to induction of labour at term.Methods: This was a hospital based, prospective randomized controlled trial conducted from August 2015 to February 2016. A total 68 patients were randomized into two groups: Mifepristone group and Oxytocin group. The improvement in Bishop’s score prior to and after 48 hours of cervical ripening, induction to delivery interval in vaginal delivery, mode of delivery, any adverse maternal and foetal outcome were recorded in both the groups.Results: The study demonstrated an overall significant improvement in Bishop’s score in mifepristone group compared to oxytocin group (p-value=0.003). A significant number of patients in mifepristone group had improved mean Bishop’s score (p-value=0.001) after 48 hours of cervical ripening. There were more vaginal deliveries in the mifepristone group, with shorter mean induction to delivery interval as compared to the oxytocin group. There were no maternal side effects and adverse perinatal outcomes in both the groups.Conclusions: Mifepristone is a good alternative to oxytocin for cervical ripening for induction of labour.


Author(s):  
Nnabugwu Alfred Adiele ◽  
Christian C. Mgbafulu ◽  
Arinze Chidiebere Ikeotuonye ◽  
Christian Chidebe Anikwe ◽  
Joshua Adeniyi Adebayo ◽  
...  

Background: The ripeness of the cervix is an important prerequisite to a successful labour induction. Use of extra-amniotic Foley catheter is a mechanical method of cervical ripening with proven efficacy. This study compared the difference in efficacy between 30 ml and 60 ml of water for inflation of Foley catheter balloon when used for cervical ripening during induction of labour.Methods: A single-blind randomized controlled study where 260 term pregnant women with intact membranes and unfavourable cervix were selected for induction of labour and randomized into two equal groups (30 ml- and 60 ml- groups) from October, 2019 to July 2020. Each participant had cervical ripening with the catheter bulb inflated with either 30 ml or 60 ml of sterile water (as assigned to the individual). After achieving favourable cervix (BS ≥6), oxytocin titration was commenced and the labour monitored with the outcomes well documented and statistically analysed.Results: Mean duration to favourable Bishop Score significantly reduced in the 60 ml group (10.8 hours±2.99) as against 12.7 hours±10.0 in 30ml group (p=0.038). Mean duration of active phase of labour was significantly reduced in 60 ml group (5.6 hours±2.4) as against 8.4 hours±3.2 in 30 ml group (p=0.010). Caesarean delivery rate was significantly reduced in the 60 ml groups (p=0.027).Conclusions: The use of 60 ml inflated Foley’s balloon catheter when compared with 30mls to ripen the cervix effectively reduced the duration to favourable Bishop Score, duration of the active phase of labour and the rate of Caesarean sections.  


Author(s):  
Thota Sai Tejaswi ◽  
Shailaja R. Bidri

Background: When the continuation of pregnancy adversely affecting the mother and fetus, termination of pregnancy is planned. Mifepristone as a method of pre-inducing agent in late pregnancy by increasing sensitivity of the uterus to the actions of prostaglandins and increasing uterine contractility. Objective of this study is to know the efficacy of mifepristone as a preinduction cervical ripening and induction of labor.Methods: In this prospective randomized study, 130 pregnant women are included and divided into two groups i.e. study group(n=65), has received tab mifepristone 200 mg and control group (n=65) has not received any drug.  After the end of 24 hours, Bishops score in both the groups are assessed and those not in labor or with unfavourable cervix are administered with intracervical dinoprostone gel every 6 hourlies for maximum of 3 doses or until pregnant woman entered into active labor. Statistical analysis regarding improvement in Bishops score, induction active phase interval, induction delivery interval is observed.Results: After 24 hours, observation in the mean Bishops score has showed significant improvement in the study group (72.33%), when compared to control group (54.58%). % woman has gone into spontaneous labor in study group (61.5%), and in control group (75.4%). Induction to active phase time duration is less in study group with mean (10.53), and in control group (17.4). Induction to delivery time duration is also less in study group with mean (15.100) when compared to control group (22.100). 67.7% of patients has delivered by vaginally in study group, and in control group 41%.Conclusions: Tab. mifepristone 200 mg has a pre inducing agent for cervical ripening, shown better improvement in Bishops score within 24-48 hours and decreases time duration from induction to active phase and induction to delivery.


Author(s):  
Neha Bansal ◽  
Divya .

Background: This study was conducted to determine the feto maternal outcome in pregnant women with thyroid disorders. The prevalence of thyroid disorders in present study was 15.75%.Methods: This was a prospective observational study carried out in all pregnant women irrespective of their parity, who attended ANC clinic in department of obstetrics and gynaecology in a tertiary care hospital over a period of 2 years. After registering, the patients were followed up with routine antenatal visits up to delivery and records were reviewed for development of abortion, PIH, preterm delivery, GDM, anemia, placental abruption, still birth, anomalies, fetal distress, meconium stained liquor, low birth weight and neonatal outcome by neonate Apgar score and TSH value.Results: Mean age group in our study was 27.61±3.14. Family history was present in 8% of study group versus 0% in control group which was statistically significant (p=0.028). Eighteen percent of preeclampsia was diagnosed in study group as compared to 4% in control group which was statistically significant (p-value= 0.005). Fourteen percent patients had preterm labour in study group as compared to 6.7% in control group which was statistically significant (p value= 0.047). Increased neonatal TSH was found in study group (61.3%) as compared to control group (32%), this difference was statistically significant (p-value <0.001). There was increased importance of measuring TSH in first trimester as it was statistically significant in study group (p-value <0.001).Conclusions: All pregnant women should be screened for hypothyroidism as early as possible or before conception to prevent any fetomaternal complications.


2019 ◽  
Author(s):  
Luz Maria Cardona-Torres ◽  
Rafael Leyva-Jimenez

Abstract Background The average percentage of births by cesarean section worldwide in 2014 was 18.6% (range: 1.4% to 56.4%), and in Latin America and the Caribbean 40.5% [range: 5.5% - 55.6%]. In Mexico, the cesarean delivery rate remained above 40% in the period from 2008 to 2015, and without signs of decreasing, the World Health Organization recommends up to 15% maximum. The objective of the study was to decrease the rate of deliveries by cesarean, through continuous intrapartum support during the active phase until birth.Methods Experimental study, open label, carried out in a public health institution in Mexico, during July-December 2018, with a study population of N = 115 women in labor (nulliparous, term, singleton, vertex) and under 40 years old, was formed a control group (n = 55) who received routine maternity care and a study group (n = 60), who received continuous intrapartum support during the active phase until birth by a professional nurse with a university degree.Results In the study group, the cesarean delivery rate was 1.7% (1 of 60), significantly lower than that of the control group, which was 29.1% (16 of 55) [X 2 = 17.13, df = 1, N = 115, p < .001], with a risk ratio of 0.06 (95% CI: 0.01 to 0.42), the absolute risk reduction was 27.4%, (95% CI: 15% to 40%), also, the hours of labour were significantly lower with a median of 6.7 hours in the study group versus a median of 13.4 hours in the control group,Conclusion Continuous intrapartum support provided by a professional nurse in the active phase helps to reduce the rate of cesarean deliveries, as well as to reduce the time of labour in women (nulliparous, term, singleton, vertex) under 40 years of age.


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