Trial of progesterone vaginal suppositories in the treatment of premenstrual syndrome.
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Clinical Trials as Topic↗
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Comparison of serum progesterone levels in dogs after administration of progesterone by vaginal tablet and vaginal suppositories.
Serum progesterone levels from a vaginal tablet formulation and six different vaginal suppository formulations, each containing 25 mg of progesterone, were evaluated in mongrel dogs. Bioavailabilities relative to an intravenous dose of progesterone were calculated. The vaginal tablet was found to have a significantly higher bioavailability compared with the vaginal suppositories.
Administration, Intravaginal↗
Management of the third stage of labor in pregnancies terminated by prostaglandin E2.
In the management of second-trimester medical terminations of pregnancy, it is a commonly accepted practice to allow 2 hours for the third stage of labor. This practice is based on data from terminations with saline solution as the abortifacient. Herein we report our experience with the use of prostaglandin E2 vaginal suppositories for midtrimester terminations, with particular regard to placental delivery rates and associated complications. Ninety-six patients underwent prostaglandin E2 vaginal suppository terminations. Fifty-eight percent of patients had spontaneous placental delivery within 2 hours of the passage of the fetus; approximately two thirds of these were expelled within 30 minutes. Previous work involving elective saline solution-induced terminations suggested the 2-hour time limit for the third stage of labor. This was based on an unacceptable complication rate of greater than 4% beyond 2 hours. The present study of the use of prostaglandin E2 suppositories for a variety of indications demonstrated a similar complication rate of 4% at 30 minutes. These findings suggest expectant management beyond this time limit may produce unacceptably high complication rates.
Abortion, Eugenic↗
Prostaglandin E2 for induction of labor in patients with premature rupture of membranes at term.
OBJECTIVE: A prospective study comparing three management schemes for patients at term with premature rupture of membranes was performed. STUDY DESIGN: One hundred forty patients were randomized to one of three study groups: prostaglandin E2, placebo, or oxytocin. Patients randomized to prostaglandin E2 and placebo received vaginal suppositories containing 3 mg prostaglandin E2 or glycerin only, respectively; suppositories were administered in a double-blind fashion, on one or two occasions, 6 hours apart. Oxytocin was given only if labor was not established after 12 hours or to augment inadequate labor. In patients randomized to oxytocin labor was induced with intravenous oxytocin. The time interval to delivery, delivery outcome, and complications were analyzed. RESULTS: Patients receiving prostaglandin E2 were more likely to be in labor after one suppository and to be delivered without the addition of oxytocin when compared with placebo. The time interval to delivery was shorter with prostaglandin E2 and oxytocin induction versus placebo ("expectant management"). The incidence of maternal infection was lowest in patients with labor induced by prostaglandin E2. Although the overall cesarean section rate was low, there was a trend toward a lower rate with prostaglandin E2 induction. No adverse effects were observed with prostaglandin E2. CONCLUSION: Prostaglandin E2 can be used successfully to induce labor after premature rupture of membranes at term with greater ease of administration when compared with oxytocin.
Cesarean Section↗
The use of a modified vaginal pouch for the diagnosis and management of premature rupture of the membranes.
A modified Reality vaginal pouch (Wisconsin Pharmacal, Jackson, Wis.) was effective in assessing membrane integrity in patients evaluated for suspected premature rupture of the membranes and was useful for collecting fluid in patients requiring pulmonary maturity studies. This technique does not alter the incidence of infection and is beneficial in the management of selected patients.
Amniotic Fluid↗
Scale of use, safety and impact of birth control methods.
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Adult↗
Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation.
A multicentre clinical trial, including 19 centres in 13 countries, assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 micrograms of levonorgestrel for at least 90 days. A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered. The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women (95% confidence interval 2.2-5.0), and of ectopic pregnancy, 0.2% (one case). The principal reasons for discontinuation were menstrual disturbances (17.2% at one year), vaginal symptoms (6.0%) and repeated expulsion of the ring (7.1%). The pregnancy rate with this 20 micrograms levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO randomized study. It is concluded that the WHO intravaginal ring releasing an average of 20 micrograms of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use.
Administration, Intravaginal↗
Clinical trial on termination of early pregnancy with RU486 in combination with prostaglandin.
Termination of early pregnancy was performed in 1572 healthy women with RU486 (mifepristone, 600mg orally once), followed 36-60 hours later by administration of methyl ester of dl-15-methyl-PGF2 alpha (PG05, 1mg vaginal suppository). Complete abortion was accomplished in 91.2% (1433/1571), incomplete abortion in 4.8% (76/1571), and continued pregnancy in 3.9% (62/1571). The time elapsed between RU486 intake and complete expulsion was 2.4 +/- 1.3 days. Expulsion took place on the third day in 935 women (72%), and on the 4th day in 273 women (21.0%). Uterine bleeding occurred on the second or third day after RU486 intake in 1256 women (88.8%), and lasted 11.7 +/- 6.4 (SD) days, range 2-55 days. One subject had blood transfusion due to excessive bleeding. The main side effects were nausea/vomiting (22.3%), abdominal pain (10.2%), headache/dizziness (4.1%) and diarrhea (2.8%). Fatal side effects have not been reported in this study. About 73% of subjects with complete abortion assessed the treatment as good to excellent. Even in the failed cases, 25-42% of subjects considered the treatment as good. Further studies are needed to determine the optimal dose of the RU486 regimen. It should be emphasized that the treatment must be used under close medical supervision in order to monitor the uterine bleeding.
Abortion, Incomplete↗
Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05--a multicentre randomized clinical trial in China.
A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 micrograms in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF2 alpha (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 micrograms was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost.
Abdominal Pain↗
Use of prostaglandin E2 vaginal suppositories in third-trimester fetal demise.
A retrospective analysis of eight cases of third-trimester fetal demise managed with prostaglandin E2 vaginal suppositories (PGE2) is presented. Management included laminaria insertion prior to induction and an initial lower dosage of PGE2. No cases of uterine rupture or cervicovaginal lacerations were encountered. A summary of the literature as it relates to PGE2 vaginal suppository use in third-trimester fetal demise is included.
Adolescent↗
Cervical ripening with intravaginal prostaglandin E2 gel.
Fifty-four patients were randomized in a double blind fashion into either a placebo group or a group treated with a 3 mg dose of an intravaginal prostaglandin E2 gel. The group receiving the prostaglandin E2 gel had a mean change in cervical score of 2.7 while the patients in the placebo group had no significant change. Even though a significantly higher number of patients in the prostaglandin group went into spontaneous labor, the incidence of cesarean section was not different between the two groups. Upon comparing the conflicting reports of various studies on the subject, it is concluded that the method of product preparation, particularly the source of prostaglandin E2 utilized and the choice of drug vehicle, may be important variables in determining treatment success, as measured in terms of decreased cesarean section rate.
Administration, Intravaginal↗
The use of 16,16-dimethyl-trans-delta 2 prostaglandin E1 methyl ester vaginal suppositories for management of missed abortion and fetal death.
The effect of vaginal administration of a PgE1 analogue to terminate missed abortion and fetal death in utero was evaluated in 62 women with gestation ranging from the 13th to the 37th week. Abortion occurred in 85.4% of women with missed abortion and in 86% of women with fetal death. In both groups, the mean induction time was less than 12 h. The incidence of side effects, primarily gastrointestinal symptoms, was infrequent.
Abortion, Missed↗
Acquired gynetresia in eastern Nigeria.
A retrospective analysis of 78 patients who presented with acquired vaginal stenosis between January 1980 and December 1989 at the University of Nigeria Teaching Hospital Enugu was carried out. Ritual circumcision was a leading cause of this condition, followed by birth injuries and postoperative injuries. Urinary symptoms such as dysuria and urinary retention, as well as coital difficulty presenting as dyspareunia and apareunia featured prominently amongst the patients. The modified Fenton's operation was used in treating a majority of the patients, with good results. Occasionally more extensive surgery such as the McIndoe operation was used when the lesion was more severe. Recurrence rate was low and 11 women became pregnant during the period of follow up. The problem is of public health dimensions, and community based education to eliminate the etiological factors is recommended.
Adolescent↗
Prostaglandin E2 vaginal suppository for induction of labour: an efficient, safe and popular method.
Two different methods for induction of labour were randomly used in 100 women with a favourable cervix. The patients were treated with either prostaglandin vaginal suppositories containing 2.5 mg PGE2 in a base of Witepsol S55 (Dynamit Nobel) or intravenous infusion of oxytocin. The PGE2 vaginal suppository was significantly more efficient than the intravenous infusion of oxytocin in relation to the time interval from the start of induction of labour to delivery. Also the percentage of women who delivered within 48 hours (success rate) was higher in the suppository group. Significantly more women in the suppository group found this induction method recommendable.
Dinoprostone↗
Ripening procedures.
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Administration, Intravaginal↗
Prostaglandin E2 (PGE2) vaginal gel for cervical ripening.
Cervical ripening prior to oxytocin stimulation is highly desirable to ensure a successful induction. Prostaglandin E2 has been administered by intracervical, intravaginal and extra-amniotic routes with successful ripening of the cervix. The dose of PGE2 administered is under investigation. Use of 3 or 4 mg of PGE2, although effective, has been reported to be accompanied by uterine hypertonus or fetal heart changes. Lower dose of PGE2 at 0.2 mg and 0.4 mg do not have the above-mentioned side effects but necessitate multiple applications. This randomized double-blinded study incorporated the use of 2 mg of PGE2 administered by intravaginal route in a hydroxyethyl cellulose gel medium. A significant increase in Bishop score (40% higher) was achieved in patients receiving PGE2 as compared to placebo patients. There were no adverse side effects, indicating application of 2 mg of PGE2 as a safe method of cervical ripening prior to induction of labor.
Cervix Uteri↗
Predictive value of pelvic scores for induction of labor by local PGE2.
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.
Adult↗
Induction of labour at term in primigravidae with low Bishop's score: a comparison of three methods.
OBJECTIVE: To determine which of three methods of induction of labour at term in primigravidae with a low Bishop's score is effective and safe. DESIGN: Random allocation to Prostin E2 and amniotomy later (Group A); low amniotomy and oxytocin titration (Group B); and intra-cervical Foley balloon overnight followed next morning by low amniotomy and oxytocin titration (Group C). SUBJECTS AND SETTING: Primigravidae (n = 90) in the University Hospitals, Benin City, Nigeria. MAIN OUTCOME MEASURE: (i) Time taken to achieve 3 uterine contractions in 10 min; (ii) induction-delivery interval. RESULTS: The mean time interval between intervention and regular uterine contractions was shortest in Group C (A vs. C, P < 0.02; A vs. B, P < 0.02). The mean induction-delivery interval was shortest in Group C (11.1 h) followed by Group B (13.9 h) and Group C (17.9 h) P < 0.05-0.001. CONCLUSION: The induction-delivery interval was shortest when using a Foley catheter for cervical ripening followed by amniotomy and oxytocin titration.
Adult↗