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.

[Intrauterine copper contraceptive implants]. / Implant intra-utérin contraceptif au cuivre (ICIU).

GyneFix, conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 women years of experience and up to 8 years of follow-up in international, multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. The following conclusions were reached: 1. The unique design characteristics of GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. GyneFix reduces the IUD-failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. 2. Frameless and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. 3. Insertion of GyneFix, with or without local anaesthesia, is easily accomplished in the office of a few minutes. Removal is easy, quick and painless. 4. GyneFix is an equally effective and well accepted method fro nulliparous women.

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.

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.

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.

Clinical experience with an ethinyl estradiol-desogestrel oral contraceptive.

Desogestrel (150 micrograms), a potent progestogen virtually devoid of androgenic activity, was used in combination with 30 micrograms ethinyl estradiol as an oral contraceptive preparation (Marvelon). 219 women completed a total of 4074 cycles, and the use-effectiveness was 0.58 Pearl Units. Serious side effects were not observed. The drug-related discontinuation index was 12.8% in six months.

The Copper-Fix (Cu-Fix): a new concept in IUD technology.

The Copper-Fix (Cu-Fix) is a thread-type copper-bearing device designed to overcome the most common IUD-related problems: bleeding and pain. Two distinctive features--virtual absence of a frame and provision of an anchoring system--make this new intrauterine device the first radical departure from current IUD technology. The Cu-Fix 390 was inserted at intervals in 382 women, and 4851 woman-months of experience had been accumulated at 18 months. The device was exceedingly well retained by the uterus (expulsion rate 0.6 at 18 months) and the removal rate for bleeding/pain was low (3.1 at 18 months). Serious complications did not occur; the pregnancy rate amounted to 0.3 at 18 months, with a continuation rate of 87.6%, which includes an 8.1% removal rate for pregnancy wish. Cardinal event rates were not influenced by the age or gravidity status of the recipient.

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.

The Ombrelle-380 IUD: a pilot study.

The initial results of a pilot trial (314 insertions and 3784 woman-months of experience at 18 months) suggest the low expulsion rate (0.0) and high clinical effectiveness (pregnancy rate 0.0) of the Ombrelle-380, a new high-load copper-releasing IUD of French origin.

Immediate postpartum insertion: performance of the Nova-T-PP and randomized comparison with the Nova-T.

Clinical evaluation of the Postpartum Nova-T or Nova-T-PP (a Nova-T IUD adapted for postpartum insertion) was based on 412 insertions and showed that this model--besides being effective and safe--had a low expulsion rate (7.2% at 1 year). To prove that the Nova-T-PP's low expulsion rate is indeed the result of its special design, a randomized trial was conducted to compare the Nova-T-PP with the parent model (Nova-T) when inserted within 10 minutes of delivery of the placenta. The result of this study (408 insertions, 203 of them Nova-T) indicate that there is no significant difference in expulsion rate between the two IUD models, suggesting that the addition of two extra arms to the original Nova-T model does not improve the retention of the adapted IUD model.

The Dimélys IUD.

The Dimélys is a new lily-shaped copper-bearing IUD of French origin of which the first clinical results are reported here. This device was inserted at interval in 348 women and 8975 woman-months of experience were accumulated at 3 years. Though only moderately effective (pregnancy rates 2.8 and 5.7 at 1 and 3 years, respectively) the Dimélys is well retained by the uterus (expulsion rates 1.5 and 2.5 at 1 and 3 years, respectively). Clinical efficacy was found to be influenced by the recipient's age, and expulsion rates were significantly higher when inserted by unskilled operators.

A randomized study of two cups for vacuum extraction.

O'Neil designed a set of suction cups which, because of more efficient lateral pull and greater maneuverability, were claimed to be more efficient and perinatally safer than the Malmström model. These claims were checked by comparing the two instruments in a randomized controlled trial comprising 410 attempted elective extractions. The two instrument groups were comparable at entry and the operators had a similar degree of experience, the sole inter-group difference being the 0.5 cm larger diameter of the O'Neil cups. No significant differences were found between the two types of instrument as to failure rate, incidence of correct cup positioning, and capacity of eliciting internal rotation nor was there a significant divergence in neonatal safety. In a few cases the perineum was lacerated by the traction cord affixed to the O'Neil instrument. The results of this study indicate that the relative advantages and disadvantages of the two cup models are unremarkable.

[Clinical study of Conova 30]. / Een klinisch onderzoek met Conova 30.

PIP: Conova 30 is a combination contraceptive in which each tablet consists of 2 mg ethynodiol diacetate and .03 mg ethinylestradiol. The preparation was offered to women who requested an oral contraceptive. Several who had contraindications for steroid contraceptives, especially oral ones, were not taken into the study. In all, 122 women were involved, comprising 902 women months. During the test no pregnancies occurred, giving a .0 Pearl index. The menstrual bleeding induced when the pill was stopped for 7 days each month showed a tendency to be shorter than the women's normal reported menstrual period (modal value 4 vs 5 days). Only 1 woman reported nausea and 2 a decrease in libido. 9 women reported significant (3-9 kg) weight gain and of these 6 found the gain sufficiently disturbing that they switched over to another preparation or another method. 12 women reported significant increases in headaches, 4 complied of vertigo, 2 of depression and 3 of "nervousness." 10 women reported breakthrough bleeding and of this group 3 switched over to an oral contraceptive with a higher estrogen dose. 6 women reported breast tension and 2 reported that spastic dysmenorrhea had disappeared since they started Conova 30. Among about 20 women whose lipid metabolism was investigated, no effect of Conova 30 was found and no thromboembolism phenomena were seen during this study. The results of this study suggest that Conova 30 is safe and effective.^ieng

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.

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.

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.

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.

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.

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.