Goserelin Acetate (Zoladex)with or without Hormone Replacement Therapy for the Treatment of Endometriosis

Objective:To determine whether hormone replacement therapy (HRT) plus goserelin (Zoladex) is as effective as goserelin alone for the relief of pelvic symptoms of endometriosis and to determine whether it reduces both the loss of bone mineral density (BMD) and the physiologic side effects associated with goserelin therapy.Design:Prospective, placebo-controlled study, open label for goserelin therapy and double-blind for HRT.Setting:Forty-two teaching or community hospitals.Patient(s):Premenopausal women with symptomatic endometriosis.Result(s):Statistically significant mean decreases from baseline in the total pelvic symptom score and total subjective score were observed by week 24 for all three groups. There were no statistically significant treatment differences for change in total symptom score. Some degree of BMD loss occurred in the three groups; however, the percentage loss was consistently greater in the HRT0 group than in the HRT1 or HRT2 groups. When analyzed separately, no overall age effect on BMD change was seen in women >30 years of age versus women ≤30 years. The HRT1 and HRT2 groups had fewer occurrences of hot flushes and vaginal dryness than did the HRT0 group.Conclusion(s):Goserelin plus HRT is as effective as goserelin alone in relieving pelvic symptoms of endometriosis and attenuates both the loss of BMD and the physiologic side effects of hot flushes and vaginal dryness associated with goserelin therapy.     

Single dose methotrexate therapy: application to interstitial ectopic pregnancy

A woman with a small (6-mm gestational sac) interstitial pregnancy had complete resolution after medical therapy alone. A single cycle of methotrexate 50 mg/m² was used as outpatient treatment without any operative procedure either for diagnosis or intervention. The guidelines that have evolved for selection of women for single dose methotrexate treatment for both intrauterine and tubal ectopic pregnancies may be applicable to interstitial ectopic pregnancy as well. A suggested framework for treatment decisions is presented.     

Factors affecting the success of human blastocyst development and pregnancy following in vitro fertilization and embryo transfer

Objective: To determine the factors affecting blastocyst development and pregnancy after IVF and ET.

Design: Retrospective analysis of data arising from a clinical trial.

Setting: Private in vitro fertilization clinic.

Patient(s): Fifty-six patients aged ≤40 years, undergoing IVF procedures for infertility, recruited specifically for blastocyst transfer.

Intervention(s): All zygotes were cultured to days 5 or 6 after insemination, and one to four of the most advanced blastocysts were transferred to the patient’s uterus.

Main Outcome Measure(s): Development of zygotes to blastocysts in vitro and pregnancy and implantation rates after ET.

Result(s): Fifty-one percent of all zygotes developed to blastocysts. Significant positive correlation between the number of blastocysts formed was observed with the number of oocytes, pronuclear zygotes, and eight-cell embryos formed. There was a negative correlation with male factor infertility. By day 5 or 6, 93% of the patients had at least one blastocysts, and the clinical pregnancy rate per transfer was 43% and the implantation per embryo transferred was 25%. No other clinical factor significantly affected the number of blastocysts formed, pregnancy rate, or implantation rate.

Conclusion(s): The numbers of oocytes, zygotes, and normally developing embryos in culture significantly affects the production of blastocysts in vitro. Male infertility significantly reduces blastocyst production. The number and the quality of the blastocysts transferred significantly influences clinical pregnancy rate.     

Extremely rare type of conjoined twins: cephalothoracopagus deradelphus

Occurrence of conjoined twins (CT) with a chromosomal abnormality is a very rare event. The case presented is that of a cephalothoracopagus Deradelphus twin with one cerebrum and two brain stems joined at the cranial end of the midbrain. This rare condition and its diagnosis and management are discussed with regard to counselling and obstetrical care.     

Reduction of De Novo Postsurgical Adhesions by Intraoperative Precoating with Sepracoat (HAL-C) Solution: A Prospective, Randomized, Blinded, Placebo-Controlled Multicenter Study

Objective: To assess the efficacy and safety of Sepracoat (HAL-C; Genzyme Corporation, Cambridge, MA) solution in reducing the incidence, severity, and extent of de novo adhesion formation at sites without direct surgical trauma or adhesiolysis at the time of gynecologic laparotomy.

Design: Prospective, randomized, blinded, placebo-controlled multicenter study. Patients underwent gynecologic procedures via laparotomy; approximately 40 days later, surgeons assessed their adhesions during second-look laparoscopy.

Setting: Twenty-three North American institutions.

Patient(s): Two hundred seventy-seven women for safety evaluations; 245 women for efficacy studies.

Intervention(s): Intraoperative serosal coating with Sepracoat (treatment) or phosphate-buffered saline (placebo) after opening of the abdominal cavity, after irrigation or every 30 minutes during surgery, and at the completion of surgery.

Main Outcome Measure(s): Incidence, severity, and extent of de novo adhesions to 23 intraabdominal sites.

Result(s): The Sepracoat group had a significantly lower incidence of de novo adhesions than the placebo group as assessed by the proportion of sites involved (0.23 ± 0.02 versus 0.30 ± 0.02, respectively) and the percentage of patients without de novo adhesions (13.1% versus 4.6%, respectively), as well as significantly reduced adhesion extent and severity. Sepracoat was well tolerated, with a safety profile nearly identical to that of the placebo.

Conclusion(s): Sepracoat was significantly more effective than placebo and was safe in reducing the incidence, extent, and severity of de novo adhesions to multiple sites indirectly traumatized by gynecologic surgery via laparotomy.     

Crinone 8% (90 mg) given once daily for progesterone replacement therapy in donor egg cycles

Objective: To determine whether once-daily dosing of Crinone 8% (90-mg progesterone vaginal gel; Serono Laboratories, Inc., Norwell, MA) is sufficient for normal endometrial development and pregnancy support.

Design: Prospective cohort study.

Setting: Academic medical center.

Patient(s): Eighty-six women who required complete progesterone replacement for a donor egg cycle.

Intervention(s): Crinone 8% (90 mg) once daily or IM progesterone (100 mg) once daily was administered from day 15 onward. Both groups underwent an endometrial biopsy on day 26 of a mock cycle, followed by a second cycle in which ET was performed.

Main Outcome Measure(s): Endometrial development, serum progesterone levels, pregnancy rates, implantation rates, and bleeding patterns.

Result(s): Mean (±SD) serum progesterone levels on day 26 were 11.3 ± 6.5 ng/mL in the Crinone group and 65.2 ± 12.5 ng/mL in the IM progesterone group. At histologic examination, endometrial biopsy specimens were found to be “in phase” for 100% (42/42) of women in the Crinone group and 95.5% (42/44) of women in the IM progesterone group. Although 8 of 42 patients had serum progesterone levels of <6 ng/mL, there was no correlation with endometrial development. Only 1 patient bled before the 14th day of progesterone therapy, and she went on to be delivered of twins. Clinical pregnancy, ongoing pregnancy, implantation, and miscarriage rates were not statistically different for the Crinone and IM progesterone groups: 45.6% (21/46) versus 52.3% (23/44); 39.1% (18/46) versus 40.9% (18/44); 21.5% (34/158) versus 19% (30/158), and 14.3% (3/21) versus 22% (5/23), respectively. Power was sufficient to detect a 25% difference in clinical pregnancy rates.

Conclusion(s): Crinone 8% administered once daily appears to produce the same endometrial development and pregnancy rates as IM progesterone in women who require complete progesterone replacement, and it does not cause early bleeding.     

The Scottish Trial of Refer or Keep (the STORK study):: midwives’ intrapartum decision making

Objectives

to explore midwives' intrapartum referral decisions in relation to their dispositional attitude towards risk.

Design

a web-based correlation study examined the association between midwife's personality (personal risk tendency), place of work (location), years of experience and the timing of their decisions to make referrals (referral score) in a series of fictitious case scenarios (vignettes).

Participants

102 midwives providing labour care in both consultant-led units (CLU) and community maternity units (CMU) from four Scottish health board areas.

Analysis

a correlational analysis was carried out to test the association between total risk scores and midwives' referral scores. Between-group comparisons were also conducted for experienced vs inexperienced midwives, midwives practising in CLU vs CMU settings and between the four health board areas.

Findings

despite being presented with identical information in the vignettes, midwives made a wide range of referral decisions. There was no association between referral scores and measures of risk, personality or years of experience. No statistically significant difference between the referral scores of midwives working in CLUs or CMUs was observed. However, a statistically significant difference did emerge between the four health board areas, with midwives from one area making referrals at a significantly earlier stage. The maternity services in this area had experienced several high profile adverse events prior to this study; this may have influenced their referral behaviour (the availability heuristic), in terms of making more cautious decisions.

Key conclusions

there was no evidence that variability in the range of referral decisions was due to personality factors, risk propensity, experience or whether the midwife worked in a CLU or CMU. Local factors such as recent adverse events may significantly influence subsequent referral behaviour. Further research is required to identify why the midwives showed so much unexplained variability in their responses to the vignettes.     

Management guidelines for obstetric patients and neonates born to mothers with suspected or probable severe acute respiratory syndrome (SARS) : No. 225, April 2009

Objective

This document summarizes the limited experience of SARS in pregnancy and suggests guidelines for management.

Outcomes

Cases reported from Asia suggest that maternal and fetal outcomes are worsened by SARS during pregnancy.

Evidence

Medline was searched for relevant articles published in English from 2000 to 2007. Case reports were reviewed and expert opinion sought.

Values

Recommendations were made according to the guidelines developed by the Canadian Task Force on Preventive Health Care.