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1.
Objective: To compare the clinical effectiveness and safety of outpatient administration of an intracervical prostaglandin (PG) E2 gel with expectant management for women with an unfavorable cervix who wish to attempt a vaginal birth after cesarean section.Study Design: This outpatient study was a randomized, multicenter investigation involving pregnant women at term with one previous low transverse cesarean section. Each had an unfavorable cervix (Bishop score ≤4) and was a candidate for vaginal delivery. Those randomly assigned to receive the gel, rather than expectant management, were given a 0.5 mg dose of PGE2 (Prepidil) intracervically at 39 weeks gestation. This cervical ripening treatment was repeated at weekly office visits for up to 3 doses.Results: Of the 294 cases, 143 received the gel while 151 underwent expectant management. No differences between the two groups were found for maternal demographics, race, parity, or predose Bishop score. The rates of repeat cesarean section did not differ (P = .68) with use of the gel (61, 42%) or with expectant therapy (48, 45%). The onset of active labor, the duration of labor among those delivering vaginally, and the 1-minute and 5-minute Apgar scores were not different between the two groups. No uterine rupture was apparent, and adverse effects during labor were as likely to occur in the two groups.Conclusions: Although its safety was confirmed for outpatient use and for persons with a prior cesarean delivery, intracervical prostaglandin E2 gel did not improve the chance of a vaginal birth after a cesarean delivery.  相似文献   

2.
OBJECTIVE: The purpose of this study was to compare the effectiveness and safety of vaginally administered 5 mg prostaglandin E2 gel prepared in our hospital pharmacy with a commercially available 0.5 mg intracervical prostaglandin E2 gel.STUDY DESIGN: Eighty-three patients undergoing labor induction were randomly assigned to one of two groups for cervical ripening. Either a preparation of 5 mg of prostaglandin E2 was placed vaginally or a commercially available 0.5 mg of prostaglandin E2 was placed intracervically. A maximum of three doses at 6-hour intervals was administered before oxytocin was begun.RESULTS: Among the 83 patients evaluated, 44 were given vaginal gel and 39 were given intracervical gel. No statistically significant differences were observed between the two treatment groups with respect to the incidence of spontaneous versus induced labor, need for oxytocin augmentation, gel-to-induction interval, Bishop score change, maximum oxytocin dose, maximum dilatation rate, length of labor, cesarean section rate, fetal Apgar scores, fetal umbilical vein pH, or fetal umbilical artery pH.CONCLUSIONS: The two prostaglandin E2 formulations appear equivalent in efficacy and safety. Constraints placed on intracervical prostaglandin E2 gel make the vaginal preparation a desirable choice. (Am J Obstet Gynecol 1997;176:1305-12.)  相似文献   

3.
OBJECTIVE: To determine whether outpatient administration of intracervical prostaglandin (PG) E2 gel decreases the interval to delivery and duration of labor. METHODS: A randomized, double-blind, placebo-controlled trial compared the intracervical placement of 0.5 mg PGE2 gel with placebo in 61 pregnant women at 38 weeks' or greater gestation with Bishop scores less than 9. Transvaginal cervical length, fetal fibronectin, and Bishop score were assessed before gel placement. Subjects were then allowed to go into spontaneous labor unless an indication for induction developed. RESULTS: Thirty women were assigned to PGE2 and 31 to placebo. There were no significant demographic differences between the groups and there were no differences in cervical length, fetal fibronectin status, or Bishop scores. Fifteen women in the PGE2 group and five in the placebo group went into labor and delivered within the first 2 days after gel placement (P = .007). The median interval to delivery was significantly shorter in the PGE2 group, at 2.5 days, compared with placebo, at 7 days (P = .02). Nulliparas in the PGE2 group had a median interval to delivery of 2 days, compared with 7 days for nulliparas receiving placebo (P = .03). Active phases of labor were significantly shorter in the PGE2 group and for women with a negative fetal fibronectin test who received PGE2. CONCLUSION: Outpatient administration of intracervical PGE2 gel shortened intervals to delivery and shortened labor.  相似文献   

4.
Artificial ripening of the unfavorable cervix was attempted in 48 women using intracervical prostaglandin (PG) E2 gel applied by a cannula and in 70 others by a newly designed double balloon device (Atad Ripener Device). In the first group (phase A), application of PGE2 gel by intracervical cannula resulted in a mean increase of 3 points in the Bishop score and a mean instillation-to-delivery time of 34.2 hours. The study of labor induction by the double balloon device was carried out in two parts. One (phase B) consisted of a double-blind randomized controlled study in which, through the double balloon device, ten women received PGE2 gel and another ten were given placebo gel. There was no significant difference in the increase of Bishop score between the two groups (5.8 points in the treatment group and 6.0 in the placebo-controlled group). Ninety percent of women in both groups delivered vaginally with a mean of 20.8 hours after device insertion. The third phase of the study consisted of an open trial of inserting the double balloon device alone without PGE2, and inflating the balloons in 50 patients. A mean increase of 4.4 points in the Bishop score was noted in these women. These findings suggest that the use of the double balloon device for ripening of the unfavorable cervix is an effective and well-tolerated method of labor induction.  相似文献   

5.
Twelve pregnant women at term with unfavorable cervices (less than or equal to 5 points according to Bishop score) were given prostaglandin E2 for cervical priming and labor induction. Prostaglandin E2 was given in the following manner: 0.5 mg in gel strictly intracervically (n = 4), extraamniotically (n = 4), or prostaglandin E2 (4 mg) in gel vaginally (n = 4). The myometrial activity was registered over a period of 30 minutes before and at least 3 hours after gel application by means of an extraamniotic microtransducer catheter. After both extraamniotic and vaginal gel application, myometrial activity was significantly increased compared with intracervical application. All the women had favorable cervical states 6 hours after treatment and were delivered vaginally within 24 hours. All infants were delivered in good condition with 1-minute Apgar scores greater than 7. From these results we conclude that proper intracervical prostaglandin E2 gel application, in contrast to extraamniotic or vaginal application, induces cervical ripening without significant myometrial activity. Because careful intracervical application appears to avoid or minimize the risks of myometrial hyperstimulation, this technique should be considered particularly in women with unfavorable cervices and delicate fetuses.  相似文献   

6.
AIM: The purpose of the present study is to compare the effectiveness and safety of a slow release vaginal PGE2 insert (Propess) with intracervical PGE2 gel (Prepidil gel) in the induction of cervical ripening and labour. METHODS: For the induction of labour we selected 103 single pregnancies at term presenting a Bishop score of less than 5. Fifty-one were induced with Propess, and 52 with intracervical Prepidil. RESULTS: The 2 groups were homogeneous as regards indications to induction and obstetric characteristics. The success of induction (achievement of uncomplicated vaginal delivery) was comparable in the 2 groups: Propess 67%, Prepidil 65%. The times needed to induce labour were on average longer with Propess (16 h 59 min) than with Prepidil (12 h 54 min), (p<0.05); nevertheless the time needed to achieve delivery by the vaginal route within 24 hours was comparable (49% vs 48%). The number of patients requiring more than one application of prostaglandin was less in the Propess group (5.9%) than in the Prepidil group (55.8%) (p<0.001). The times relative to dilation and expulsion did not differ significantly. Resort to cesarean section for fetal indication (cardiotocographic changes) was greater in inductions with Prepidil (8 cases) compared to Propess (2 cases), p<0.05. CONCLUSION: The systems proved equally effective, nevertheless Propess seems to be safer thanks to the lower incidence of cardiotocographic changes such as to indicate urgent cesarean section. Propess would seem to be more acceptable on the part of patients thanks to the smaller number of applications necessary.  相似文献   

7.
OBJECTIVE: To estimate the adverse effects of glyceryl trinitrate compared with prostaglandin (PG) E2 vaginal tablet for cervical ripening in term pregnancy. METHODS: One hundred ten women with term pregnancies referred for induction of labor with Bishop scores of 6 or less were randomly assigned to receive a 500-microg glyceryl trinitrate tablet vaginally (n = 54) or a 3-mg PGE2 tablet vaginally (n = 56), every 6 hours for maximum of two doses. Subjects were sent to the labor ward for amniotomy or oxytocin if their Bishop scores were more than 6 or their cervices were not ripe 24 hours after treatment. Adverse effects, changes in the Bishop scores, progress, and outcomes of labor were assessed. RESULTS: Glyceryl trinitrate was associated with fewer episodes of uterine tachysystole (0% versus 9%; P =.02). The median Bishop score after 12 hours was lower in women given glyceryl trinitrate compared with those given PGE2. Adverse effects, including headache and palpitations, were more frequent with glyceryl trinitrate than with PGE2. The cesarean rate was not significantly different between groups. CONCLUSION: Cervical ripening with glyceryl trinitrate resulted in fewer episodes of tachysystole, but there were significantly more minor side effects. It can be used for cervical ripening at term, but it was not as effective as PGE2.  相似文献   

8.
OBJECTIVE: This study was designed to determine whether use of prostaglandin E(1 )(PGE(1)) is justified to improve the known clinical outcome of prostaglandin E(2) (PGE(2)) gel, because PGE(2) gel preparations are more costly than PGE(1) tablets in most countries, and data to support the use of the gel in clinical practice is not conclusive. The aim was to compare the safety and efficacy of PGE(1) gel when applied in both an in-hospital or ambulatory setting to oxytocin infusion in those women with unfavorable cervical conditions prior to surgical abortion for either medical or obstetrical indications with intrauterine fetal demise. Surgical dilatation of the unripe cervix may result in cervical injury of uterine perforation which could prolong the hospital stay. METHODS: We used PGE(1) gel prepared from tablets and administered in the ambulatory form (group 1), the same PGE(1) gel administered in the labor room (group 2) and intravenously administered oxytocin in the labor room (group 3) for the induction of abortus in women complicated with intrauterine fetus death and missed abortion. Patients requesting abortion were eligible for inclusion, with >8 and <13 weeks of gestation. Eighty-nine women with unfavorable cervices (Bishop score 相似文献   

9.
A prospective, randomized, controlled clinical trial was conducted to evaluate the safety and efficacy of a single, 0.5-mg dose of prostaglandin E2 gel in a shelf-stable triacetin base administered intracervically in patients with an unfavorable cervix (Bishop score less than or equal to 4) 12 hours prior to oxytocin-induction of labor. forty-eight evaluable patients were enrolled, 25 in the PGE2 group and 23 in the control group. PGE2 gel treatment resulted in a significant improvement in the mean Bishop score compared to control (3.14 versus 0.70, P less than .00005). Sixty-four percent of the patients treated with PGE2 had regular uterine contractions during the 12-hour preinduction period beginning 2.18 +/- 2.0 hours after gel insertion, compared to 9% in the control group, P = .0001. Moreover, 12% (3/25) of the patients receiving PGE2 progressed into active labor and delivered during the preinduction period. The duration of oxytocin infusion required for the induction or augmentation of labor was significantly shorter for patients who received intracervical PGE2 gel compared to the control group (13.1 +/- 8.1 versus 19.0 +/- 8.7, P less than .05). However, there was no significant difference in the incidence of cesarean section between the two study groups (40 and 22% in the PGE2 and control groups, respectively). No episodes of uterine hypertonus or hyperstimulation or gastrointestinal side effects occurred as a result of PGE2 gel treatment.(ABSTRACT TRUNCATED AT 250 WORDS)  相似文献   

10.
Labor characteristics and quantitation of uterine activity resulting from oxytocin induction of labor after intracervical prostaglandin E2 (PGE2) gel priming have not been previously reported. Forty-seven women with modified Bishop scores of 5 or less received preinduction priming with 0.5 mg of intracervical PGE2 gel. Oxytocin was used to induce labor after priming, and uterine activity was quantitated. A matched group of control patients was managed identically but did not receive PGE2 gel. In the gel group, modified Bishop scores improved significantly and in two patients (4%), priming alone induced labor. No uterine hyperstimulation or fetal heart rate abnormalities occurred during priming. Cesarean sections for all indications and those for failed induction were less common in the gel group. The length of the active phase and the second stage of labor were significantly shorter in the gel group. Uterine activity was similar in both groups. The data suggest a primary cervical action of the gel.  相似文献   

11.
OBJECTIVE: To compare dinoprostone gel and insert in achieving successful vaginal delivery in nulliparous and multiparous women. STUDY DESIGN: 220 nulliparous and 100 multiparous with a Bishop score < or =7 were randomized to receive dinoprostone either gel or insert for cervical ripening. The main outcome measures were the rate and latency of vaginal delivery. RESULTS: In nulliparous women no significant differences were found between the gel and insert groups in the rate of vaginal delivery (85.6% vs. 80.7%) delivery < or =12 (36.8% vs. 32.9%) and < or =24h (85.3% vs. 93.4%) regardless of the preinduction Bishop score. Nulliparous with Bishop score < or =4 treated with the insert had a decreased risk (p<0.05) of post partum hemorrhage (4.8%) when compared with nulliparous treated with gel (16.7%). On the contrary, in multiparous the time to delivery interval was significantly shorter in the gel treated group (9.9+/-4.9h vs. 13.1+/-5h; p<0.001) with more patients delivering vaginally < or =12h (75% vs. 37.5%, p<0.001), regardless of the preinduction Bishop score. CONCLUSION: Both dinoprostone gel and insert are efficient in achieving cervical ripening and successful labor in nulliparous and multiparous. In multiparous, however, the gel significantly reduces the time to vaginal delivery with more patients delivering vaginally < or =12h, regardless of the Bishop score.  相似文献   

12.
To investigate the best route of prostaglandin medication for induction of labor, 125 pregnant women with unfavorable cervices (Bishop scores less than or equal to 6) were randomized to induction of labor with either PGE2 (0.5 mg) in a viscous intracervical gel once daily or PGE2 pessaries (2.5 mg) 1-2 a day. As estimated by life table analysis, the pessaries were significantly more effective inducing vaginal delivery compared to intracervical gel (24 h: P less than 0.025, 48 h: P less than 0.01, logrank test) and vaginal delivery was obtained within 24 h/48 h in 50%/72% of the women in the pessary group and in 29%/55% of the women in the intracervical group. Cervical ripening was found within 3 h (P less than 0.001) and in the subsequent 3 to 24 h period (P less than 0.005) after both treatments, no difference being found between the groups. The pessaries were much more effective inducing regular contractions compared to the intracervical gel (P less than 0.005, logrank test), so the latter seems preferable if cervical ripening rather than induction is intended. No difference was found analyzing the active labor period. No difference was found in methods of delivery, neonatal parameters (Apgar scores, umbilical artery blood pH and standard base excess), and the patients' attitude towards both methods of induction were equally favorable.  相似文献   

13.
Introduction: an important factor in the success of labour induction is the presence of a ripe cervix. The safety and efficacy of outpatient prostaglandin E2 (PGE2) administered intracervically compared to extra-amniotic cervical Foley catheter placement to ripen the cervix were studied. Patient satisfaction and overall cost with both methods were reported for the first time.Methods: pregnant women with uncomplicated term pregnancies having an indication for induction of labour were enrolled. Singleton pregnancies with intact membranes and cervical Bishop scores < 5 were randomized blindly to receive .5 mg intracervical PGE2 (n=67) every six to eight hours or intracervical Foley catheter (extra-amniotic) (n=62) insertion overnight. Cervical assessments were carried out prior to treatment and again before induction of labour. Patients filled out a post-treatment Likert questionnaire.Results: overall change in Bishop score did not differ between the two groups. The Foley treatment group were more likely to have Mated to three to four cm (χ2=5.48 DF=1 p=.02). Intrapartum variables, mode of delivery and post-partum complications were similar. For patients completing the questionnaire, pain experienced during insertion was similar, however, fewer patients would recommend the Foley catheter treatment to a pregnant friend (F[1,64]=5.53 p=.02). The price of the Foley catheter is much less than the PGE2.Conclusion: both methods lead to similar changes in overall Bishop score although the intracervical Foley catheter was more likely to lead to cervical dilatation of three centimetres or more—a dilatation which facilitates amniotomy. There were no differences in the mode of delivery, maternal or neonatal outcomes. Patients reported the same amount of pain with both treatments but patients seem to prefer the more expensive PGE2.  相似文献   

14.
Intracervical prostaglandin in postdate pregnancy. A randomized trial   总被引:1,自引:0,他引:1  
A study was designed to see if incorporating intracervical administration of prostaglandin could affect the outcome of postdate pregnancies. All patients with verified dates, at least 41 6/7 weeks pregnant and enrolled in an antepartum testing schedule were randomized in a double-blind fashion to receive either 0.5 mg of prostaglandin E2 (PGE2) suspended in methylcellulose or a placebo of the gel alone. The gel was inserted directly into the cervical canal after the patient had a reactive/negative contraction stress test. The patient was then observed on an external fetal monitor for an hour before going home. A total of 23 patients received PGE2, and 20 received the placebo. Results were analyzed for the following: change in the Bishop score, lag time from dosage to delivery, spontaneous versus induced labor, cesarean section rate, length of labor and neonatal outcome. There were no significant differences between the groups except in the incidence of patients going into labor within 72 hours. The results indicate that, in general, 0.5 mg of intracervical PGE administered at greater than or equal to 41 6/7 weeks without subsequent oxytocin induction of labor did not appear to significantly alter the obstetric outcome.  相似文献   

15.
Summary: One hundred and nineteen women with singleton pregnancy and cephalic presentation requiring induction of labour in the presence of an unfavourable cervix (Bishop score ≤ 4) were studied. Five patients were excluded because of failure to comply with the protocol. Cervical ripening was carried out using 3 different methods; 36 used the Atad Ripener Device, 39 received 0.5 mg PGE, intracervical gel and 39 received at least one 3 mg PGE2 intravaginal pessary. There were no differences in the demographic characteristics and the indications for induction. Five patients developed complications during the ripening period necessitating intervention; 3 required emergency Caesarean section and 2 delivered vaginally. Although statistically there were no differences among the 3 methods of cervical ripening, the power of the study is probably not large enough to show the differences. The PGE2 pessary appears to be more effective with 68% of patients either going into labour during cervical ripening or succeeding in the cervical ripening compared to around 50% in the Atad and PGE, gel groups. The vaginal delivery rate was 87.2% in the pessary group compared to 72.2% in the Atad group and 84.6% in the gel group. The duration of labour was also shorter in the pessary group with 73.5% delivered within 24 hours compared to 57.7% in the Atad group and 57.6% in the gel group. Although the results of the Atad device seem to be inferior, the risk of uterine hyperstimulation from the use of the device is probably lower than that of the PGE2 and may therefore be preferable in women with fetuses at high risk of fetal hypoxia.  相似文献   

16.
In 42 patients with intrauterine fetal death between the 29th and 43rd week of gestation, a standard, 2-step procedure was employed to deliver the dead fetus. After priming with an intracervical application of PGF2 alpha- or PGE2-gel, labor was induced by extra-amniotic prostaglandin (PG) gel or oxytocin infusion while under epidural anesthesia. Intracervical PG application led to a significant improvement in the modified Bishop score from 1.3 to 7.6 after a mean of 8 h. In 20 patients labor and progressive dilatation of the cervix occurred after intracervical PG gel application alone. The average total therapy time was 18.1 h in patients treated with PGF2 alpha and 13.7 h in the PGE2-treated group. The average induction of labor to delivery intervals were 8.8 h in the PGF2 alpha- and 7.1 h in the PGE2-group. Gastrointestinal side effects were observed in only 5 patients. The combination of cervical ripening with intracervical PG gel application and induction of labor by extra-amniotic PG gel under epidural anesthesia is an efficient and safe method for treatment of intrauterine fetal death.  相似文献   

17.
Preinduction cervical ripening with prostaglandin E2 intracervical gel   总被引:1,自引:0,他引:1  
A double-blind, placebo-controlled, dose-ranging study was undertaken to evaluate the efficacy of two doses of intracervical prostaglandin E2 gel in patients with unfavorable Bishop scores. Mean change in Bishop score, success of softening, time to labor, and time to delivery were all significantly different in the two treatment groups as compared with the placebo group. Twenty-three of 30 treated patients had uterine contractions lasting greater than four hours and eight patients delivered during the observation period. Moreover, one case of uterine hyperactivity and five cases of severe fetal heart rate decelerations were noted in the treatment groups. Although efficacious for cervical ripening, caution is warranted when using this technique in patients at risk for placental insufficiency.  相似文献   

18.
OBJECTIVE: To assess the clinical efficacy of pharmacologic, mechanical and combination techniques of cervical ripening. STUDY DESIGN: From March 1997 to August 1998, all cervical-ripening patients at Lehigh Valley Hospital were randomly assigned to three groups: intravaginal misoprostol, intracervical Foley catheter, or combination prostaglandin E2 (PGE2) gel and Foley catheter. Inclusion criteria included Bishop score < or = 5 and no contraindication to labor. The remaining delivery process was actively managed according to established guidelines. Multiple variables in perinatal outcome were analyzed, with the cesarean section rate and time from ripening to delivery as the main outcome variables. RESULTS: Of the 205 patients, 65 were randomized to the misoprostol group, 71 to the Foley group and 69 to the catheter-and-gel group. There were no differences between groups in delivery indications, maternal demographics, ultrasound findings, labor interventions, intrapartum times, mode of delivery, postpartum complications or neonatal outcomes. The misoprostol group demonstrated a higher rate of uterine tachysystole and required oxytocin less when compared to the two catheter groups. CONCLUSION: The higher rate of uterine tachysystole with misoprostol did not increase the cesarean section rate. The higher rate of oxytocin required by the two catheter groups did not increase the delivery time intervals. There appears to be no benefit to adding intracervical or intravaginal PGE2 gel to the intracervical Foley balloon. The misoprostol and catheter ripening techniques have similar safety and efficacy.  相似文献   

19.
A randomized, prospective study compared the safety and efficacy of hygroscopic cervical dilators (36 patients) with intracervical prostaglandin E2 (PGE2) gel (38 patients) in preinduction cervical ripening. Maternal age, gestational age and parity were similar in both groups. Both groups had similar cervical Bishop scores upon admission. The change in the cervical score was 3.0 +/- 0.3 (mean +/- SEM) in the dilator group and 2.8 +/- 0.4 in the PGE2 group (P = .7). The mean length of time from amniotomy to delivery was similar in both groups (10.1 +/- 1.0 and 10.3 +/- 1.3 hours, respectively) (P = .9). The proportions of patients in each arm of the study undergoing cesarean section were similar. Eight cesarean sections (21.0%) were performed in the PGE2 group; seven (19.4%) were performed in the dilator group (P = .9). Maternal morbidity, five-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the two groups. Because patients were required to stay in the labor-and-delivery unit for four to six hours of fetal monitoring after PGE2 application, the costs were higher in that group. The dilators and PGE2 gel appear comparable in efficacy as preinduction cervical ripening agents. The need to monitor patients receiving PGE2 gel, however, appears to favor the choice of the dilators from a cost and convenience perspective.  相似文献   

20.
The predictive value of pelvic scores, parity, age and gestational age for induction of labor by local prostaglandin-E2 (PGE2) was examined in 336 women attempting induction of labor by intracervical or vaginal PGE2. The patient characteristics were correlated to: (1) vaginal delivery within 48 h, (2) the period from induction to onset of labor (latency period), and (3) the duration of labor. The Bishop score (P < 0.01) and even more the Lange score (P < 0.0001) were significantly inversely correlated to both latency period and induction-delivery period. This was caused by cervical dilatation (P < 0.001), fetal station (P < 0.05) and cervical length (P < 0.05), whereas position and consistency of the cervix were of no importance. All three periods studied were significantly (P < 0.0001) shorter in parous women. In primiparous women, gestational age was of no importance for the latency period; however, higher gestational age was associated with longer labor (P < 0.001). We conclude that the predictive value of pelvic scores on induction hardly differs using local PGE2 compared to conventional methods; furthermore, the Bishop score should be substituted, disregarding position and consistency of the cervix, but putting more weight to cervical dilatation. A new pelvic score is proposed.  相似文献   

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