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Biomedical subjects

M Bygdeman

Publications and source records attributed to M Bygdeman.

At least 145 records · Page 8Linked to original sources
PubMed1984

Termination of very early pregnancy by RU 486--an antiprogestational compound.

RU 486, a new antiprogestational compound, was given to 37 women seeking termination of pregnancy and with amenorrhea of 42 days or less. One patient was found at the second follow-up visit to have an extrauterine pregnancy. The patients received either 25 mg, 50 mg or 100 mg RU 486 twice daily for four days. All patients attended three follow-up visits, one, two and five to six weeks after the start of therapy. The start, duration and amount of bleeding as well as plasma progesterone, beta-hCG and cortisol concentrations were determined for each treatment day and at the follow-up visits. All patients but three started to bleed during treatment. Frequency of complete abortion was 61% (22 out of 36 patients). In only three patients was the pregnancy unaffected by treatment. The clinical efficacy of the treatment was not dose-dependent. Most of the patients experienced only minor side effects in terms of mild uterine pain, nausea and vomiting. However, two patients suffered from heavy bleeding requiring blood transfusion and curettage. In the patients with complete abortion, beta-hCG values decreased significantly but not until the first follow-up visit. The plasma progesterone also decreased. The decrease appeared earlier with the higher daily dose of RU 486. Cortisol concentrations increased during treatment with all 3 dosage regimens but the levels remained within the normal range. It is concluded that treatment with RU 486 may provide a novel therapy for "menstrual regulation" but the efficacy of the treatment needs to be improved to compete with alternatives such as vacuum aspiration.

Abortifacient Agents↗
PubMed1984

Randomized comparison of prostaglandin treatment in hospital or at home with vacuum aspiration for termination of early pregnancy.

In the present study the efficacy and the acceptability of vaginal administration of a prostaglandin E analogue (9-deoxo-16, 16-dimethyl-9-methylene-PGE2) in hospital or at home were randomly compared with vacuum aspiration for termination of very early pregnancy. Prerequisites for acceptance of the patients were a normal pregnancy, a duration of amenorrhea of 49 days or less, at least one previous full-term pregnancy, and a healthy status. Fifty-three patients fulfilled these criteria and adhered to the protocol. Seventeen patients were treated with prostaglandin at home, 18 with prostaglandin in the hospital (9-methylene-PGE2, 50 to 60 mg twice at 6-hour intervals), and 18 with vacuum aspiration. Each patient was interviewed twice by a trained female psychologist before the treatment and two weeks after. Both the surgical and the nonsurgical methods (at home and in the hospital) were found to be equally effective in terms of frequency of complete abortion. Prostaglandin therapy was associated with a higher frequency of gastrointestinal side effects, pain, and a longer duration of bleeding than was the surgical procedure. The acceptability study showed that prostaglandin treatment was positively received. The patients who were treated with prostaglandin remained very positive after the abortion; a majority of these patients intended to use the same procedure in case of a repeated abortion, and would also recommend the treatment to a relative or a friend. The results of the present study indicate that termination of early pregnancy by a medical method, even if self-administered, is an acceptable procedure at least in selected patients. Further efforts to improve the treatment seem therefore justified.

16,16-Dimethylprostaglandin E2↗
PubMed1984

Cervical dilatation with 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (Cervagem) prior to vacuum aspiration. A double-blind, placebo-controlled randomized study.

In the article are presented the results of a randomized double-blind study comparing the efficacy and tolerance of vaginal administration of 1.0 mg 16,16-dimethyl-trans-delta 2-PGE1 methyl ester and placebo as a pretreatment to vacuum aspiration for termination of pregnancy in nulliparae in the 8th to 12th weeks of gestation. One-hundred and-twenty-six patients fulfilled all the criteria for acceptance in the study and received either 1 mg of the E analogue or placebo three hours prior to vacuum aspiration. The mean cervical dilation at operation was following treatment with the E analogue 6.5 mm and with placebo 4.9 mm (p less than 0.001). The number of patients requiring no further mechanical dilation or the dilatation was considered easy was significantly higher in the prostaglandin-treated group than in the placebo group (p less than 0.001). The mean blood loss at operation was also higher in the placebo group (p less than 0.001). Uterine pain was slightly more common following prostaglandin treatment (p less than 0.05) while gastrointestinal side effects occurred equally often in both groups. In two patients the uterine wall was perforated, both perforations occurring in the placebo group. Late complication rates were comparable between the two groups. It can be concluded that pretreatment with the E analogue accomplishes sufficient dilatation and softening of the cervix in most patients. The efficacy of the procedure and its low frequency of side effects and complications make the procedure useful for cervical dilatation prior to vacuum aspiration in late first trimester pregnancy.

Abortifacient Agents↗
PubMed1984

The natural variations in prostaglandin concentration in human seminal fluid and its relation to sperm quality.

Prostaglandins E, F, 19-hydroxy E, and 19-hydroxy F (PGE, PGF, 19-OH-PGE, and 19-OH-PGF) in human semen were determined by a new chemical method. The method allows liquefaction to occur, a prerequisite for simultaneous estimation of PG concentration and sperm characteristics in the same ejaculate. The present study showed also that the variation in PG concentration between different individuals was more pronounced than in repeated ejaculates from the same individual. Sperm density and sperm motility seemed related to PG concentration. A high density was associated with a low PG concentration. The concentration of 19-OH-PGE was higher and that of 19-OH-PGF lower in ejaculates with a normal sperm motility than in those with an abnormal motility. It seems that functional requisites of sperm depend upon optimal seminal PG concentration.

Alprostadil↗
PubMed1984

Tissue polypeptide antigen immunoreactivity in human semen.

A substance with TPA immunoreactivity is present in human seminal plasma. This seminal plasma TPA shows immunological similarity with TPA isolated from a pool of carcinoma tumors. TPA is taken up by live spermatozoa and it cannot be easily washed out. Split-ejaculate studies suggest that TPA originates mainly from the prostate. TPA is not correlated with the spermatozoa count, total number of spermatozoa, percentage of normal spermatozoa, or forward motility. The mean seminal plasma concentration of TPA in morphologically normal ejaculates is 14,531 U/liter. No difference was found in the TPA levels between the normal group and various groups of patients under investigation for involuntary infertility.

Adult↗
PubMed1984

The use of prostaglandins and their analogues for abortion.

In general, termination of second trimester pregnancy is associated with three to five times higher morbidity and mortality risks than termination during the first trimester. The procedures mainly used are extra- or intra-amniotic administration of solutions such as hypertonic saline, ethacridine lactate, PGF2 alpha and PGE2. In comparison with these procedures, the use of prostaglandin analogues may offer important advantages, the most important one being the possibility of using non-invasive routes of administration. The continuous development of new analogues has now resulted in compounds that are highly effective in stimulating uterine contractility and are associated with a low frequency of side-effects; these compounds are suitable for both vaginal and intramuscular administration and are applicable for termination of pregnancy during both the early and late parts of the second trimester. The most widely used method for termination of first trimester pregnancy is vacuum aspiration. It is a highly effective procedure and the overall complication rate is low. One problem with vacuum aspiration is the mechanical dilatation of the cervical canal which is necessary from at least the 8th week and onwards. Pretreatment with laminaria tents or with prostaglandin analogues eliminates or reduces the need for mechanical dilatation and significantly facilitates the procedure. Pretreatment with prostaglandin analogues also reduces the risk of both operative and postoperative complications. The prostaglandins also offer a possibility as a non-surgical procedure for termination of very early pregnancy. Both vaginal and intramuscular administration of the latest generation of PG analogues have been shown in several studies to be equally as effective as vacuum aspiration if the treatment is restricted to the first three weeks following the first missed menstrual period. Gastrointestinal side-effects are still a problem although of significantly less importance than if natural prostaglandins are used. Preliminary studies in which one of these PGE analogues was administered by the vaginal route indicate that self-administration at home starts to be a reality in selected patients.

Abortifacient Agents↗
PubMed1983

The F and 19-hydroxy F prostaglandins and their 8 beta-isomers in human seminal plasma: data on chromatography and mass spectrometry.

Human seminal plasma contains eight different prostaglandins belonging to the F series, i.e. PGF1 alpha, PGF2 alpha, 19-hydroxy-PGF1 alpha, 19-hydroxy PGF2 alpha, as well as the corresponding 8 beta-isomers. A systematic description of the mass spectrometric fragmentation of the 8 beta-isomers has not been previously reported. In the present study the prostaglandins were separated from human seminal plasma and analysed as methylester, trimethylsilylethers with gas chromatography mass spectrometry. All the eight F and 19-hydroxy F prostaglandins fragmented in the same manner, but the relative abundances of the formed ions varied in a typical way. Thus, the mass spectra of 8 beta-PGF1 alpha and 8 beta-19-hydroxy PGF1 alpha differed clearly from those of their 8 alpha-isomers, which could be used for identification and should be considered in selected ion monitoring. The ratio between the seminal plasma levels of 8 beta- and 8 alpha-isomers of 19-hydroxy F1 alpha was much higher than the corresponding ratio for the PGF1 alpha.

Dinoprost↗
PubMed1983

Experience with an industrially manufactured gel PGE2 for cervical priming.

An industrially manufactured ready-to-use PGE2 gel for cervical ripening was clinically evaluated. The study included 42 primiparous and eight multiparous women with an unfavourable cervix (Bishop score less than or equal to 5) admitted to hospital for induction of labour on medical grounds. PGE2, 0.5 mg, in 2 ml triacetin gel was instilled into the cervical canal. In nine patients (18%) the gel induced labour and subsequent delivery. In the remaining women the mean Bishop score increased from 3.0 to 7.7 during a 24-h period and labour was induced by either i.v. oxytocin or PGF2 alpha. None of the 50 patients experienced gastrointestinal side effects during pretreatment with PGE2. In 50% of the patients slight uterine contractility was noticed. All patients went into labour. The incidence of Cesarean section was 10%. Except for two patients treated because of intrauterine fetal death there was no perinatal mortality. The 5-min Apgar score was 8 or more in all newborn but 1. The main advantage of the new gel is that it is ready to use without any mixing procedure. Moreover, the stability of PGE2 is sufficient to allow routine clinical use.

Adolescent↗
PubMed1983

Comparison of different prostaglandin analogues and laminaria for preoperative dilatation of the cervix in late first trimester abortion.

The present study included 550 mainly primiparous women in the 8th to 12th week of pregnancy admitted to the hospital for termination of pregnancy. The patients were treated by different prostaglandin analogues or one medium size laminaria tent followed by vacuum aspiration. The treatment period was three hours, which for some analogues was extended to six and twelve hours. The prostaglandins studied were 15-methyl PGF2 alpha methyl ester (0.5 and 1.0 mg), 16,16-dimethyl-trans-delta 2 PGE1 methyl ester (1.0 mg), 9-deoxo-16,16-dimethyl-9-methylene PGE2 (30 mg), all administered by the vaginal route, and 16-phenoxy-omega-17,18, 19,20-tetranor PGE2 methyl sulfonylamide (0.25 and 0.5 mg) given as i.m. injections. At operation the degree of cervical dilatation, the amount of blood loss and other operative complications were registered. The patients were continuously supervised during treatment and during at least three hours after operation. Side effects, complications and vital signs were recorded. The degree of cervical dilatation was related to the duration of prostaglandin treatment. If the duration of prostaglandin treatment was prolonged, the frequency of gastrointestinal side effects, abortion prior to scheduled time for vacuum aspiration and pain needing analgesic treatment also increased. Both the efficacy and the frequency of side effects were dose dependent. The outcome of therapy after three-hour pretreatment was evaluated. All the prostaglandins were more effective than one medium size laminaria tent in dilating the cervical canal. The three E analogues were most effective. The number of patients with bleeding at operation of 50 ml or more was also higher following laminaria than following prostaglandin pretreatment. Most advantageous in this respect were the three E analogues. Frequency of gastrointestinal side effects and degree of pain following 9-methylene PGE2 and 16,16-dimethyl PGE1 methyl ester was the same as following laminaria treatment.

16,16-Dimethylprostaglandin E2↗
PubMed1983

Menses induction and second-trimester pregnancy termination using a polymeric controlled release vaginal delivery system containing (15S)15-methyl PGF2 alpha methyl ester.

A polymeric controlled release vaginal delivery system was developed for 15(S)15-methyl PGF2 alpha methyl ester. This delivery system is a reservoir-type device consisting of laminated membranes that are mounted on an inert holder. The delivery systems were designed to have in vitro steady-state release rates of 50 or 100 micrograms/hr. Included in the study were seven early pregnant (amenorrhea up to 49 days) patients who were treated with 50 micrograms/hr devices and five early pregnant patients who were treated with 100 micrograms/hr devices. Three second-trimester cases received a 50 micrograms/hr device and five received a 100 micrograms/hr device. Five of the seven early first-trimester patients given 50 micrograms/hr devices aborted completely. The plasma levels of PG in those patients were 400-600 pg/ml for up to 6 hours. In the two cases that did not abort completely, the plasma levels of drug dropped sharply after both patients had started to bleed vaginally one hour after administration of the device. All five early pregnant patients treated with 100 micrograms/hr devices aborted completely. None of the three second-trimester cases aborted within 24 hours following administration of the 50 micrograms/hr devices. Three of the five second-trimester patients aborted within 24 hours following treatment with 100 micrograms/hr devices. The plasma levels of drug reached 1-1.5 ng/ml during the first 2-5 hours and then declined, especially after rupture of the membranes. The variation of plasma levels of drug following vaginal administration of the devices in different individuals was considerably less than following vaginal suppositories. Therefore, this device seems to be close to an ideal delivery system for vaginal administration of abortifacients.

Abortifacient Agents↗
PubMed1983

Gas chromatographic--mass spectrometric quantitation of 16, 16-dimethyl-trans-delta 2-PGE1.

Di-deuterated and di-tritiated 16,16-dimethyl-trans-delta 2-PGE1 has been synthesized and used for development of a GC-MS method for quantitation of corresponding unlabelled drug in patient plasma. Although these carrier/internal standard molecules only contain 2 deuterium atoms the lower limit of detection at each injection is as low as about 40 pg. The maximum plasma levels of this drug following administration of vaginal suppositories used in clinical studies (1 mg 16,16-dimethyl-trans-delta 2-PGE1 methyl ester in 0.8 g Witepsol S-52) were 100-350 pg/ml i.e. in the same order of magnitude as earlier seen for 16,16-dimethyl-PGE2.

Alprostadil↗
PubMed1983

Termination of second-trimester pregnancy by laminaria and intramuscular injections of 15-methyl PGF2 alpha or 16-phenoxy-omega-17,18,19, 20-tetranor PGE2 methyl sulfonylamide. A randomized study.

The present study included 120 second-trimester patients admitted to the hospital for termination of pregnancy. In all patients, one medium-size laminaria tent was introduced into the cervical canal. The laminaria was withdrawn 12 hours later and the patients randomly allocated to either i.m. injection of 15-methyl PGF2 alpha, 0.25 mg every second hour, or 16-phenoxy-omega-17,18,19,20-tetranor PGE2 methyl sulfonyl-amide, 0.5 mg every fourth hour. Both treatment schedules were equally effective. All patients but 2 (98.3%), one in each group, aborted within 24 hours of prostaglandin treatment. Both methods seem far more effective than other methods at present in use for termination of second-trimester pregnancy. With the E analogue, the frequency of gastro-intestinal side effects was significantly lower than with the F analogue and not more common than following hypertonic saline. The use of laminaria tent was normally uneventful and seemed to reduce the risk of cervical laceration significantly.

Abortion, Induced↗
PubMed1983

Pre-abortion treatment with a single vaginal suppository containing 9-deoxo-16,16-dimethyl-9-methylene PGE2 in late first and early second trimester pregnancies.

In the present study the efficacy of a new stable prostaglandin E analogue, 9-deoxo-16,16-dimethyl-9-methylene-PGE2 (9-methylene-PGE2), administered as a single vaginal suppository for preoperative dilatation of the cervical canal was evaluated in 382 mainly nulliparous patients. Late first trimester patients received either 20 mg 3 hours prior to or 30 mg 12 hours prior to vacuum aspiration. Early second-trimester patients received 40 mg of the analogue and vacuum aspiration was performed 12 hours later. The degree of cervical dilatation was related to the pretreatment time and the dose of 9-methylene-PGE2. However, even with 20 mg of the analogue and 3 hours pretreatment time, cervical dilatation was adequate in almost 40% of the patients and in the remaining women further mechanical dilatation was regularly performed with ease. The frequency of gastro-intestinal side effects was significantly lower than that found for comparable doses of 15-methyl-PGF2 alpha methyl ester administered by the same route. With 20 mg 9-methylene PGE2, side effects were very rare; only 9% of the patients experienced occasional episodes of vomiting. Three hours' pretreatment with 20 mg of the analogue seems suitable for late first trimester pregnant women in whom the abortion is performed on an outpatient basis. For early second trimester patients pretreatment with 40 mg 9-methylene-PGE2 for 12 hours followed by vacuum aspiration seems to be a better alternative than the two-stage procedures in current use.

16,16-Dimethylprostaglandin E2↗
PubMed1983

The use of prostaglandins for termination of abnormal pregnancy.

Termination of abnormal pregnancy has long been a major gynecological problem. Both surgical and non-surgical procedures are associated with a significant risk for both minor and major complications. Treatment with natural prostaglandins and especially prostaglandin analogues administered by non-invasive routes seems to be an attractive alternative to methods in current use. In the present study 68 consecutive patients with a missed abortion or hydatiform mole were treated with vaginal suppositories containing either 15-methyl-PGF2 alpha methyl ester or 9-deoxo-16,16-dimethyl-9-methylene PGE2. When the uterine size at treatment was 13 weeks or less, vacuum aspiration was performed 12 hours after start of prostaglandin therapy (group I: 41 patients). When the uterus was larger, curettage was performed only after abortion (group II: 27 patients). In group I approximately 45% of the patients aborted within 12 hours from the start of prostaglandin treatment. In the remaining patients the cervical canal was sufficiently dilated and the uterus contracted to allow an easy evacuation. In group II all patients aborted within 26 hours from start of therapy. No serious complications were observed. Both prostaglandin analogues seemed equally effective in terminating an abnormal pregnancy. The E analogue has the advantage of causing significantly fewer gastro-intestinal side effects than the F analogue, though temperature elevation is more common with the former. It may be concluded that vaginal administration of prostaglandin analogues is a simple and effective therapy for termination of abnormal pregnancy and seems to offer considerable advantages over methods in current use.

16,16-Dimethylprostaglandin E2↗
PubMed1982

Plasma levels of 9-deoxo-16,16-dimethyl-9-methylene-PGE2 in connection with its development as an abortifacient.

Gaschromatographic-mass spectrometric quantitation of 9-deoxo-16,16-dimethyl-9-methylene-PGE2 in plasma samples obtained during constant intravenous infusion of the drug revealed that a plasma level of about 20 ng/ml was associated with high enough uterine contractility for induction of second trimester abortions. This level was therefore aimed for during the development of formulations and dose schedules for interruption of pregnancy with this drug. For the first time it was possible to induce second trimester abortions through oral administration of a prostaglandin analog, although the plasma levels were low giving a moderate success rate (about 50%) within 25 hours. Rectal administration of 20 mg of the drug at 6 hours intervals resulted in high enough plasma levels for second trimester abortions. Highly efficient dose schedules for interruption of early first trimester ("menses induction") and second trimester pregnancies through vaginal administration were developed. The frequency of side effects in the early first trimester were so low that "home treatment" was possible. Formulations suitable for 3, 6 or 12 hours preoperative dilatation of the cervix were also developed.

16,16-Dimethylprostaglandin E2↗