Clinical experience with the GYNE-T 380 postpartum intrauterine device.

OBJECTIVE: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions. DESIGN: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus. PATIENTS, PARTICIPANTS: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites. MAIN OUTCOME MEASURES: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively. RESULTS: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.

PIP: The insertion of conventional IUDs during the 1st 10 days after delivery is associated with a high rate of expulsions. The Gyne T 380 (Ortho Pharmaceutical, Canada Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no.2 catgut to the top of the IUD (Gyne T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the of the uterine fundus. This modified IUD was evaluated in a phase II trial involving 190 women at 4 clinical sites; continuation rate was 74/100 women, the life table expulsion rate as 9.6 and 13.3/100 women observed at 6 and 12 months, respectively. There were no pregnancies during the 1st year of study. Complications associated with the insertion and use of this IUD were minimal and largescale trials evaluating this IUD are now in progress.

Immediate postplacental IUD insertion: a randomized trial of sutured (Lippes Loop and TCu22OC) and non-sutured (TCu22OC) models.

A randomized clinical trial concerning immediate post-placental insertion (IPPI) of the Delta Lippes Loop, Delta TCu22OC, and TCu22OC was undertaken to assess the effect of the addition of catgut strands on IUD performance. A total of 906 devices were inserted and the subjects followed for 20 months, at which time 14,136 woman-months experience had been accumulated. The Delta Loop constantly had inadmissibly high expulsion and pregnancy rates. The two T-IUD models had significantly lower rates of expulsion and pregnancy, and these rates were similar for the sutured and the non-sutured TCu22OC. Immediate postplacental insertion of the three IUD models was totally safe in terms of infection and perforation. Due to the difficulty of insertion and high expellability, the Delta Loop is considered unfit for IPPI. Performance of the TCu22OC was good but the results did not indicate that "suturing" improved the retainability of this IUD model significantly.

Immediate postplacental insertion and fixation of the CuFix postpartum implant system.

Since promising results were obtained with the CuFix interval implant system in international clinical trials conducted worldwide, a modification of the device adapting it for immediate postplacental insertion and fixation (IPPIF) seemed a logical approach to solve the expulsion problem of IUDs inserted at that particular time. Seventy-three insertions were performed at three university centers, during 1990 and 1991, both by skilled and unskilled investigators. The results of this multicenter study show the excellent retainability of the modified IUD supporting the validity of the anchoring principle. The insertion procedure is easy, requiring minimal training, and the insertion technique appeared to be safe.

PIP: Physicians inserted the CuFix postpartum (CuFixPP) implant system, an IUD, to a depth of 1.3 cm in the fundal myometrium in 73 healthy women soon after vaginal delivery (10-30 minutes) at either the University Hospital in Gent, Belgium; the University Medical School in Debrecen, Hungary; or Alexandra Hospital of the University of Athens in Greece. Since previous international clinical trials showed unacceptably high rates of expulsion of CuFixPP, researchers conducted this trial to test the IUD after having it modified for immediate postplacental insertion and fixation. None of the physicians had received training in the insertion procedure of this experimental IUD. The cumulative expulsion rate at 12 and 18 months was 3.1. The cumulative pregnancy rate at 12 and 18 months stood at 1.5. The sole reasons for removal at 12 and 18 months were bleeding/pain and planned pregnancy (7.4 at 12 and months and 10.8 at 18 months; 9 at 12 months and 12.2 at 18 months, respectively). Physicians experienced difficulty removing the IUD in 4 cases. The removals did not cause noticeable bleeding. No complications occurred. These findings revealed that, with further modifications, the CuFixPP IUD holds considerable promise as a simple and effective method of postpartum contraception, which can easily be inserted by nurses or midwives, especially in developing countries.

Preinduction cervical ripening with prostaglandin E2: influence on psychomotor evolution in the first year.

The long-term effects of elective preinduction of labor at term by extra-amniotic instillation of prostaglandin E2 in methylhydroxyethylcellulose gel were evaluated in 20 children. No untoward effect of this procedure on the neurologic state of the newborn or the psychomotor development of the children during the first 12 months was found.

Prostaglandin F2 alpha for interrupting pregnancy, managing intrauterine death and molar pregnancy and inducing labor.

Serial intramuscular injections of 250 microgram of 15 (S), 15-methyl-prostaglandin F2 alpha were given to 105 women every 1-3 hours in an attempt to induce second-trimester abortion (N = 80) or labor (N = 25), the latter because of late intrauterine death or anencephaly. The treatment was highly successful; the cumulative expulsion rates at 12 and 24 hours were 69% and 95%, respectively. There were no serious complications, and significant alterations in the mother's vital signs were uncommon. Gastrointestinal side effects are tolerable if the woman is properly premedicated and maintained on the antiemetic, antidiarrheic and analgesic treatments.

PIP: Serial intramuscular injections of 250 mcg of 15(S,15-methyl-prostaglandin F2alpha were given to 105 women every 1-3 hours in an attempt to induce second trimester abortion (N=80) or labor (N=25). Patients were divided into 5 groups: those with missed abortions; those with pregnancy terminations; those with molar pregnancy; those with intrauterine death; and those where labor was induced with a live anencephalic fetus. The treatment was highly successful; the cumulative expulsion rates at 12 and 24 hours were 69% and 95% respectively. There were no serious complications, and significant alterations in the mother's vital signs were uncommon. Gastrointestinal side effects are tolerable if the woman is properly premedicated and maintained on the antiemetic, antidiarrheic, and analgesic treatments.

[Tubal sterilization by minilaparotomy]. / Tubasterilisatie via minilaparotomie.

PIP: A study of methods, techniques, and instruments used in surgical contraceptive procedures from approximately 1965-1978, makes the assertion that the ideal sterilization technique still has not been invented, while at the same time noting that transcervical and transuterine sterilizations are still in the research stage, and tubal sterilization has attained considerable popularity as an everyday practice. Passing attention is given to culdotomy, culdoscopy, laparoscopy, and laparotomy, while stressing minilaparotomy as the current most widely used means of female sterilization. An overview of the history of the minilaparotomy is presented, as well as the results of a study conducted from February 1976 to December 1977 at the Gynecological Clinic in the Academy Hospital in Hoofden involving 102 nonpregnant women who received minilaparotomies. Of the participants, who were aged 19-47 (average age 35 and average parity 2.7), 80 were sterilized electively, and 22 medically. The length of incision varied from 1-6 cm; the average length of operation was 31 minutes; the period for recovery from flatus was 0-3 days; and the average length of stay in a clinic 3.2 days. Morbidity figures were low, the most frequent wound complication being hematoma (3%); this agrees with reports in the literature since 1976 of nonlethality in 17,500 minilaparotomy sterilizations.^ieng

Pelvic Girdle Pain during or after Pregnancy: a review of recent evidence and a clinical care path proposal.

PROBLEM STATEMENT: Pelvic girdle pain (PGP) is a common condition during or after pregnancy with pain and disability as most important symptoms. These symptoms have a wide range of clinical presentation. Most doctors perceive pregnancy related pelvic girdle pain (PPGP) as 'physiologic' or 'expected during pregnancy', where no treatment is needed. As such women with PPGP mostly experience little recognition. However, many scientific literature describes PPGP as being severe with considerable levels of pain and disability and socio-economic consequences in about 20% of the cases. OBJECTIVES: We aimed to (1) inform the gynecologist/obstetrician about the etiology, diagnosis, risk factors, and treatment options of PPGP and (2) to make a proposition for an adequate clinical care path. METHODS: A systematic search of electronic databases and a check of reference lists for recent researches about the diagnosis, etiology, risk factors and treatment of PPGP. RESULTS: Adequate treatment is based on classification in subgroups according to the different etiologic factors. The various diagnostic tests can help to make a differentiation in the several pelvic girdle pain syndromes and possibly reveal the underlying biomechanical problem. This classification can guide appropriate multidimensional and multidisciplinary management. A proposal for a clinical care path starts with recognition of gynecologist and midwife for this disorder. Both care takers can make a preliminary diagnosis of PPGP and should refer to a physiatrist, who can make a definite diagnosis. Together with a physiotherapist, the latter can determine an individual tailored exercise program based on the influencing bio-psycho-social factors.

Local administration of (15 S)-15-methyl PGF2 alpha for management of hypotonic post-partum hemorrhage.

Local (uterine) injection of (15 S)-15-methyl prostaglandin F2 alpha was highly effective as first-aid treatment for hypotonic post-partum hemorrhage and only 2% of the 50 treated patients required surgical intervention for such hemorrhage. Systemic side-effects did not occur, and besides the procedure is extremely simple as well as painless.

Termination of second-trimester intrauterine fetal demise with prostaglandins.

PIP: Recently proposed techniques for the termination of 2nd trimester missed abortion based on administration of the natural prostaglandins (PGs) E2 and F2 alpha or analogs derived from the parent compounds are described. With few exceptions the techniques are still experimental because of the number of cases treated remains small or because the preparations are not available for clinical use. Interpretation of reported results is often difficult because of incomplete description of procedures and pooling of missed abortion and missed labor. Because of troublesome side effects after systemic administration of natural PGs, the present tendency is to favor local administration or to use synthetic analogs that have a longer half-life and greater uterotonic potency. Choice of a PG compound depends largely on availability, whereas the route of administration is determined by expertise and available facilities. Among the recently proposed PG techniques, repeated application of intravaginal PGE2 pessaries has yielded reported success rates higher than 95% with no serious complications reported but frequent unpleasant side effects. The gastrointestinal (GI) symptoms may be alleviated by preabortion cervical priming and use of antiemetic and antidiarrheal drugs. Extra amniotic administration of natural PGs appears to be highly effective for termination of missed abortion without production of side effects. Application of PG-gel is simpler than continuous infusion; the use of an indwelling catheter probably accelerates the effect. Serial intramuscular 15-me-PGF2 alpha is also highly effective. The frequency and intensity of associated GI side effects can be reduced to tolerable levels by using antiemetic and antidiarrheal drugs or reducing dosages. Intravenous or intramuscular administration of the utero-selective PG analog sulprostin is acceptable because of the lack of side effects and high success rate. Cervical priming before the procedure is started has been found to shorten the induction-abortion time and to improve the success rate when natural PGs and analogs are used to terminate fetal demise.^ieng

Intravenous infusion of prostaglandin E2 for management of premature rupture of membranes.

In term with premature rupture of the membranes (PROM) and an unripe cervix who have no contraindications for prostaglandin (PG) administration and vaginal delivery, intravenous (I.V.) infusion of titrated PGE2 is highly effective. In healthy gravidas with dito fetus this treatment appeared perinatally safe and was well tolerated by the mother. To enhance its safety margin and procedure must be conducted under toco-cardiographic control.

Termination of pregnancy by intramuscular administration of 15 (S)-15-methyl-prostaglandin in F2 alpha.

The use of 15 (S)-15-methyl-prostaglandin F2 alpha for second-trimester termination of pregnancy, induction of labor in the presence of a dead or severely malformed fetus, and the management of molar pregnancy was investigated in 212 women. The dosage regime was 250 microgram of the prostaglandin analogue every 1 to 3 hours. Cumulative expulsion rates amounted to 94 and 97% after 24 to 36 hours, respectively. Gastrointestinal side effects occurred in 48% of the patients, and both the number and intensity of the episodes were significantly reduced by antiemetic and antidiarrheal drugs. No serious complications occurred.

Prostaglandins for the management of anencephalic pregnancy.

In 17 women carrying an anencephalic fetus (3 or them dead) an attempt was made to terminate the pregnancy with either intravaginal suppositories containing 20 mg prostaglandin E2 each or serial intramuscular injections of 250 microgram of 15(S)-15-methyl-prostaglandin F2 alpha. The duration of pregnancy ranged from 18 to 39 weeks (mean: 28.5 weeks). Fifteen women expelled the complete uterine contents after a period ranging from 4:15 to 39:10 h:min (mean: 15:11 h:min) following the initiation of treatment. There were two failures, and in both of these cases labor started spontaneously after cessation of the prostaglandin treatment. No serious complications occurred. The PG treatment induced no changes in routine laboratory values and significant alterations in the mother's vital signs were uncommon. Even though intravaginal prostaglandin E2 and intramuscular 15-methyl-prostaglandin F2 alpha often produced gastro-intestinal side effects, there can be no doubt as to the unique utility of these compounds for the management of anencephalic pregnancies, whatever the duration of gestation and vital status of the fetus.

Candidiasis in women fitted with an intrauterine contraceptive device.

Vaginal colonization by Candida spp. was compared in 117 women fitted with an intrauterine contraceptive device (IUCD users) and in 100 women not wearing an IUCD (control group). None of the subjects had factors currently assumed to predispose to yeast colonization or infection. Yeasts were present significantly more often in the IUCD users (20%) than in the control group (6%). In two of the 21 women with positive cultures the tail of the IUCD yielded substantially more colonies than the vaginal specimen and in seven, only the tail culture was positive. These findings strongly suggest that the IUCD is a predisposing factor in vaginal colonization by Candida strains. In half the women the presence of yeasts in the vagina was not associated with signs and symptoms of clinical infection. Of the 29 yeast strains isolated 17 were C. albicans, there was no difference in the prevalence of C. albicans between IUCD users and non-users or between symptomatic and asymptomatic women.

PIP: 217 women were investigated for the presence of genital candidiasis. 117 women had an IUD; the other 100 women did not. 23 IUD wearers and 6 of the non-wearers were found to harbor Candida in the vagina. 50% of the IUD wearers and 66% of the yeast-positive controls were asymptomatic. Pieces of IUD tails were snipped and cultured from 21 of the IUD wearers, and in 7 of them only the IUD tails yielded cultures. 59% of the yeasts were identified as Candida albicans and the rest as other strains of Candida. This study confirms the hypothesis that IUD use predisposes to colonization and infection by Candida albicans and other strains. The fact that the yeast organisms were more prevalent on the IUD tails than in the vaginal mucosa indicates that the IUD tail acts as a reservoir of infection.

Management of second-trimester missed abortion with intramuscular 15-methyl-prostaglandin F2 alpha.

Midtrimester missed abortion was successfully managed by serial intramuscular injections of 15(S)-15-methyl-prostaglandin F2alpha (PGF2alpha) in 255 patients, the cumulative abortion rates after 24 and 36 hours being 97.6 and 99.6%, respectively. The mean 1st-dose-to-expulsion interval was significantly shorter in the paras, but the period after fetal death was not significant in this respect. In 60% of the cases, abortion was complete. No serious complications occurred. 2/3 of the patients developed gastrointestinal side effects. These side effects were not improved by standardized antiemetic and antidiarrheal treatment, but they were strongly reduced by priming the cervix with extraamniotic PGE2 gel before the PGF2alpha analog was administered.

Gestodene: clinical experience with an innovative progestogen used in a combination oral contraceptive preparation.

The contraceptive efficacy, tolerance, and safety of a new monophasic oral contraceptive that combines 75 mcg gestodene (delta-15- levonorgestrel) and 30 mcg ethinyl estradiol were studied in 75 women (944 cycles) currently at risk for pregnancy. 20 women were nulliparous. No woman became pregnant during the trial, nor were vital signs of body weight affected by the drug. Cycle control was excellent, with no bleeding irregularities in 92% of the cycles. Serious complications did not occur. The low incidence of side effects, e.g. headache (9%) and breast tenderness (8%), indicated that the gestodene combination was well-tolerated. In a subgroup of 10 women, no changes in routine laboratory tests could be demonstrated after 12 cycles of treatment.

Assessment of a two dose scheme of PGE2 gel for preinduction cervical softening.

A single dose technique of endocervically administered 0.5 mg PGE2 triacetin gel has been reliably effective for preinduction cervical softening. This study examined the value of a 2 times 0.25 mg dosing scheme over a 12 hour period and compared it with the single dose method. It was concluded that there was no advantage in the two dose scheme and given the potential for contamination or inadvertent rupture of the membranes with more frequent dosing, the single application remains the procedure of choice.

Extra-amniotic prostaglandin E2 gel vs. amniotomy for elective induction of labour.

A randomized study was performed to compare three methods of labour induction in 143 clinically normal women (43 nulliparas) at term: amniotomy with or without intravenous oxytocin, extra-amniotic prostaglandin (PG) E2 gel, and extra-amniotic PGE2 gel plus an indwelling catheter. The three methods appeared to be comparable in effect and all of them were perinatally safe. Thus, if preference is given to keeping the ovular sac intact during the early phase of induced labour, extra-amniotic PGE2 in viscous gel, either with or without an indwelling catheter,. can replace the classical induction technique.

Chronic stimulation of uterine prostaglandin synthesis during cervical ripening before the onset of labor.

Concentrations of 13,14-dihydro-15-keto-PGF2 alpha (PGFM) were measured in plasma of six carefully selected primigravid women with an unripe cervix at term before and at various intervals after extra-amniotic insertion of a Foley catheter with or without methylhydroxyethylcellulose (Tylose) gel. The procedure caused an acute elevation of PGFM levels within 5 min (P less than 0.025), which was maintained for at least 6 hours in the absence of uterine activation at 179 +/- 32% of the initial values (P less than 0.01). Extra-amniotic administration of Tylose gel caused an increase in PGFM levels which was both higher and more prolonged (greater than 12 hours) than insertion of a Foley catheter alone. The observations indicate that cervical ripening without concomitant uterine activation is associated with an increase in PGFM levels. They also demonstrate that prolonged activation of (intra) uterine prostaglandin synthesis may occur several hours before the onset of labor-like uterine activity. A chance finding further suggests that spontaneous rupture of the membranes too may be preceeded by an increase in (intra) uterine prostaglandin synthesis. In their totality these observations lend strong support to the proposition that an increase in (intra) uterine prostaglandin production is a prerequisite to rather than a consequence of the initiation of labor.