Single shot prostaglandin gel for labor induction.

A viscous suspension of prostaglandin E2 was introduced endocervically to induce labor in patients with favourable induction features. The method was found to be effective and compared favourably with the conventional practices of amniotomy and intravenous oxytocin infusion or oral prostaglandin therapy. Several advantages were found including a high degree of patient acceptability.     

Clinical experiences with a new gel for intracervical application of prostaglandin E2 before therapeutic abortion or induction of term labor

A new gel for intracervical application of prostaglandin E₂ (PGE₂) has been elaborated and evaluated. The main component of the gel is a cross-linked starch polymer to which prostaglandins can be added and preserved for long-term storage (> 12 months).In a double blind study, 20 patients requiring legal abortion in late first trimester were given gel containing 0.25 mg PGE₂ or gel without PGE₂. The gel was applied within the cervical canal. In all patients receiving PGE₂-gel, a rapid ripening of the cervix occurred which facilitated the subsequent dilatation and evacuation. In patients receiving gel without PGE₂ cervix did not ripen. In a subsequent open study, 30 patients were treated with PGE₂-gel before therapeutic abortion. The same degree of cervical ripening was registered as for the patients receiving PGE₂-gel in the double blind study.In 50 patients at term, intracervical application of 3 ml gel containing 0.50 mg PGE₂ induced labor in 27 cases, i.e. 54 per cent of the patients. In the remaining undelivered women, a prominent cervical ripening occurred within 24 hours. No side effects of the treatment were observed.We conclude the new PGE₂-gel to be a promising future alternative in the treatment of patients with an unfavorable cervix, prior to surgical evacuation of the uterus in late first trimester abortion, as well as before induction of labor at term.     

Controlled trial of induction of labor by vaginal suppositories containing prostaglandin E2.

A group of 84 women at 39-43 weeks of pregnancy were randomly allocated to a blind trial of induction of labor with vaginal suppositories containing inert material or either 0.2 mg or 0.4 mg of prostaglandin E2. The suppositories were self-administered every two hours during waking hours on two successive days until labor started or 15 had been used. Side-effects were absent. Labor was established within 48 hr of insertion of the first suppository in 9.3% of control patients, 65.4% of those treated with 0.2 mg PGE2 and 85.7% of those treated with 0.4 mg PGE2. The mean Apgar scores in the three groups were the same. The mean total dose of PGE2 were 2.0 mg (0.2 mg group) and 2.3 mg (0.4 mg group). It is concluded that vaginal PGE2 is an effective and acceptable method of inducing labor at term.     

Effectiveness of extra-ovular injection of prostaglandin E2 in tyloseR gel to ripen the cervix prior to elective induction of labor at term

Ripening of the unfavorable cervix (Bishop score ? 4) was obtained in 92 clinically normal gravidae at term (68 nulliparae and 24 parous women), not in labor and with intact membranes, by injecting one or two doses (250 to 500 μg each) of prostaglandin (PG) E2 suspended in a viscous gel (5% Tylose^R) into the extra-ovular space. On average 7 to 8 hours after the injection the mean increase of the cervical score was 3.7 and 4.1 in the nulliparous and parous women, respectively. Complications associated with placement of the catheter were few. The method is simple, well tolerated and no untoward maternal or perinatal effects could be directly attributed to it. However, suitable criteria for predicting both the effect of the procedure and the optimal PG dose to be administered are still needed.     

控释前列腺素E2-普贝生用于足月妊娠引产的疗效观察

目的:探讨控释前列腺素E2栓剂普贝生用于足月妊娠引产的有效性及安全可行性.方法:将本院2008年12月2009年4月有引产指征的足月妊娠孕妇140例随机分成两组,研究组以普贝生用药,对照组行催产素静滴引产,比较两组产妇Bishop评分、引产费用、临产时间、破膜时间、分娩时间、总产程时间、分娩情况和结局以及新生儿体重及评分.结果:普贝生组用于足月妊娠引产效果明显优于对照组(P＜0.01),研究组用药至临产时间显著短于对照组(P＜0.01),引产成功率高于对照组,对母婴影响无显著差别.结论:普贝生是一种安全有效方便实惠的新型引产药物,对母婴没有明显不良影响,可在,临床上应用.     

控释前列腺素E2^-普贝生用于足月妊娠引产的疗效观察

目的：探讨控释前列腺素E2栓剂普贝生用于足月妊娠引产的有效性及安全可行性。方法：将本院2008年12月2009年4月有引产指征的足月妊娠孕妇140例随机分成两组,研究组以普贝生用药,对照组行催产素静滴引产,比较两组产妇Bishop评分、引产费用、临产时间、破膜时间、分娩时间、总产程时间、分娩情况和结局以及新生儿体重及评分。结果：普贝生组用于足月妊娠引产效果明显优于对照组（P〈0.01）,研究组用药至临产时间显著短于对照组（P〈0.01）,引产成功率高于对照组,对母婴影响无显著差别。结论：普贝生是一种安全有效方便实惠的新型引产药物,对母婴没有明显不良影响,可在临床上应用。     

A comparison of buccal (oromucosal) and oral prostaglandin E2 for the elective induction of labor

In 100 clinically-normal women, labor was induced at term by low amniotomy and PGE2. The drug was administered by either the oral or the oromucosal route, the same incremental dose scheme (initial dose of 0.5 mg; hourly increment of 0.5 mg until adequate uterine stimulation or a maximum single dose of 3.0 mg) being applied.Both routes of administration had comparable efficacy and were equally safe. The incidence of abnormal monitoring findings (uterine hypertonus, transient bradycardia and dips II during the first stage; late decelerations, progressive and transient bradycardia during the second stage of labor) and of low Apgar scores was similar. Acid-base and lactate-pyruvate equilibria in mother and fetus were not influenced by the route of drug administration in parous women. In nulliparae treated with PGE2 by the oromucosal route, higher values were found for the fetal-maternal difference in excess lactate than in those given oral PGE2; however, this is probably of little clinical importance.     

Single extra-amniotic injection of prostaglandin E2 in viscous gel to induce mid-trimester abortion.

In a preliminary study a single extra-amniotic injection of 1.5 mg of prostaglandin E-2 incorporated into an aqueous viscous gel was given to 24 patients aborted within 24 hours, and the mean induction-abortion interval (plus or minus S.E. of mean) was 13.5 plus or minus 1.5 hours. Vomiting occurred in seven patients, and transient severe uterine cramps, pallor, nausea, and shivering occurred in one patient immediately after injection. Complete abortion occurred in 20patients. A delay in the time taken to abort seemed to be associated with an immediate and rapid rise in uterine tone after the injection which required prompt analgesia; this probably reflected rapid decidual absorption and dissolution of the prostaglandins away from their site of action. The degree of distention of the catheter-retaining balloon did not influence abortion times.     

A comparison of buccal (oromucosal) and oral prostaglandin E2 for the elective induction of labor.

In 100 clinically-normal women, labor was induced at term by low amniotomy and PGE2. The drug was administered by either the oral or the oromucosal route, the same incremental dose scheme (initial dose of 0.5 mg; hourly increment of 0.5 mg until adequate uterine stimulation or a maximum single dose of 3.0 mg) being applied. Both routes of administration had comparable efficacy and were equally safe. The incidence of abnormal monitoring findings (uterine hypertonus, transient bradycardia and dips II during the first stage; late decelerations, progressive and transient bradycardia during the second stage of labor) and of low Apgar scores were similar. Acid-base and lactate-pyruvate equilibria in mother and fetus were not influenced by the route of drug administration in parous women. In nulliparae treated with PGE2 by the oromucosal route, higher values were found for the fetal-maternal difference in excess lactate than in those given oral PGE2; however, this is probably of little clinical importance.     

Controlled trial of induction of labor by vaginal suppositories containing prostaglandin E2

A group of 84 women at 39 – 43 weeks of pregnancy were randomly allocated to a blind trial of induction of labor with vaginal suppositories containing inert material or either 0.2 mg or 0.4 mg of prostaglandin E₂. The suppositories were self-administered every two hours during waking hours on two successive days until labor started or 15 had been used. Side-effects were absent. Labor was established within 48 hr of insertion of the first suppository in 9.3% of control patients, 65.4% of those treated with 0.2 mg PGE₂ and 85.7% of those treated with 0.4 mg PGE₂. The mean Apgar scores in the three groups were the same. The mean total dose of PGE₂ were 2.0 mg (0.2 mg group) and 2.3 mg (0.4 mg group). It is concluded that vaginal PGE₂ is an effective and acceptable method of inducing labor at term.     

Endocervical prostaglandin E2 gel for preinduction cervical softening

A single, endocervical application of a new commercial preparation of prostaglandin E2 (PGE2) gel, 0.5 mg of PGE2 in 2.5 ml (3 g), was evaluated for preinduction cervical softening. Safety and efficacy were assessed in a comparison with a 2.0 mg PGE2 vaginal tablet and placebo in normal nulliparous women at term, with low Bishop scores. Treatment was administered in randomized, double blind fashion. Overall success, defined as a progression in Bishop score of at least 3 points within 12 hours, was achieved in 22/40 (55%) of the gel group, 15/41 (37%) in the tablet treated women, and 8/40 (20%) in those receiving placebo. Of interest was the observation that of women with very unfavorable induction features (Bishop score 0-2), the cervical gel treatment resulted in a 6/8 (75%) success rate compared with 2/13 (15%) success for the vaginal tablet and 0/17 (0%) for placebo. In as much as a very low incidence of side effects accompanied this treatment scheme, expanded multi-center testing is recommended.     

Comparative study of oestradiol and prostaglandin E2 vaginal gel for ripening the unfavourable cervix before induction of labour.

Oestradiol 150 mg and prostaglandin E2 (PGE2) 4 mg suspended in viscous gel and applied intravaginally were compared with regard to ripening the unfavourable cervix of patients randomly allocated to two study groups. In primigravidae no significant difference was observed in the efficacy of the two substances. Some multiparous patients, however, had considerably more uterine sensitivity to PGE2 quickly developed decelerative cardiotocographic tracings after insertion of the gel. In the group given oestradiol there was a significant absence of uterine activity after gel application. The findings suggest that oestradiol applied vaginally is a safe, comfortable, cheap, and equally effective alternative to PGE2 for ripening the cervix, without the disadvantages of uterine stimulation frequently encountered with PGE2.     

Amniotic fluid prostaglandin E2 in preterm labor

These studies were designed to determine amniotic fluid concentrations of prostaglandin E2 (PGE) in women with preterm labor. Amniotic fluid was retrieved by transabdominal amniocentesis from 68 women with preterm labor (less than 37 weeks). Patients were divided into three groups according to the response to tocolysis and the presence or absence of an intraamniotic infection. Amniotic fluid concentrations of PGE2 were significantly greater in women with preterm labor and intraamniotic infection than in women without infection. Patients unresponsive to tocolysis without intraamniotic infection had a significantly greater concentration of PGE2 in amniotic fluid than those responsive to tocolysis.     

Cervical ripening prior to induction of labor (intracervical application of a PG E2 viscous gel).

In 38 pregnant patients at term with unfavorable cervices labor induction was initiated with PG-E2 after a preceding intracervical application of 0.1, 0.2 or 0.3 mg PG-E2 in 1 ml viscous gel. The mean Bishop score improved from 3.36 to 7.0 in an average time of 2 h 37 min. The cervical diameter increased from 14 mm to 22.7 mm. 31 patients delivered their babies spontaneously, while 7 patients were delivered by cesarean section due to cervical dystocia and delayed labor. Fetal outcome was normal in all cases, with an average Apgar score of 8.7 and an average pH-value in the umbilical artery of 7.245. The study indicates that local application of PG-E2 induces cervical dilatation, and is of particular use in patients presenting a low Bishop score. A possible local effect of PG E2 is discussed.     

Endocervical prostaglandin E2 gel for preinduction cervical softening

A single, endocervical application of a new commercial preparation of prostaglandin E₂ (PGE₂) gel, 0.5 mg of PGE₂ in 2.5 ml (3g), was evaluated for preinduction cervical softening. Safety and efficacy were assessed in a comparison with a 2.0 mg PGE₂ vaginal tablet and placebo in normal nulliparous women at term, with low Bishop scores. Treatment was administered in randomized, double blind fashion. Overall success, defined as a progression in Bishop score of at least 3 points within 12 hours, was achieved in 22/40 (55 %) of the gel group, 15/41 (37 %) in the tablet treated women, and 8/40 (20 %) in those receiving placebo. Od interest was the observation that of women with very unfavorable induction features (Bishop score 0–2), the cervical gel treatment resulted in a 6/8 (75 %) success rate compared with 2/13 (15 %) success for the vaginal tablet and 0/7 (0 %) for placebo. In as much as a very low incidence of side effects accompanied this treatment scheme, expanded multi-center testing is recommended.     

Secretion rate of prostaglandin F during induced labor in goats

Relationships between plasma flow and plasma concentrations of prostaglandin F were examined in the utero-ovarian veins of three pregnant goats. Plasma flow, measured by veno-arterial dilution of para-Aminohippurate in two goats, was unchanged or increased slightly when PGF concentrations were elevated by short-term infusions of PGF_2α into a uterine vein. Utero-ovarian plasma flow was measured during labor in two goats. Flow doubled during advanced labor and then decreased sharply to very low rates during the terminal expulsive phase of stage II labor.A total of 8.3 and 9.5 mg PGF was released into the utero-ovarian vein of two goats during the last 6 hours before fetal delivery and maximal release rates of approximately 100 ug. min⁻¹ were obtained some 5–10 minutes before delivery was completed. The highest plasma concentrations of PGF were detected immediately after completion of fetal delivery when utero-ovarian plasma flows were lowest.     

Amniotic fluid prostaglandin D2 in spontaneous and augmented labor

Prostaglandin D2 (PGD2) was quantified in human amniotic fluid obtained from women in various phases of the first stage of spontaneous labor, augmented labor, and induced labor. PGD2 increased significantly only in late labor in the spontaneous and augmented labor groups.     

Cervical ripening with intravaginal prostaglandin E2 gel.

We describe a technique of administering prostaglandin E2 (PGE2) in a viscous cellulose gel into the vagina to ripen the unfavourable cervix in patients requiring induction of labour. A total of 168 primigravidae were studied, of whom 102 received 2 mg PGE2 in 2% gel and 66 received 5 mg PGE2 in 4% gel. In the latter group, the state of the cervix was significantly improved in 58 patients (87.9%), while 32 (48.5%) had started labour before planned induction. There were no maternal or fetal side effects or complications.     

Cervical ripening prior to induction of labor (intracervical application of a PG E2 viscous gel)

In 38 pregnant patients at term with unfavorable cervices labor induction was initiated with PG-E₂ after a preceding intracervical application of 0.1, 0.2 or 0.3 mg PG-E₂ in 1 ml viscous gel. The mean Bishop score improved from 3.36 to 7.0 in an average time of 2 h 37 min. The cervical diameter increased from 14 mm to 22.7 mm. 31 patients delivered their babies spontaneously, while 7 patients were delivered by cesarean section due to cervical dystocia and delayed labor. Fetal outcome was normal in all cases, with an average Apgar score of 8.7 and an average pH-value in the umbilical artery of 7.245. The study indicates that local application of PG-E₂ induces cervical dilatation, and is of particular use in patients presenting a low Bishop score. A possible local effect of PG E₂ is discussed.