No reduction of manual removal after misoprostol for retained placenta: a double-blind, randomized trial.

OBJECTIVE: To test the effect of 800 µg of misoprostol orally on the prevention of manual removal of retained placenta. DESIGN: Multicenter, double-blinded, placebo-controlled, randomized trial. SETTING: One university and one non-university teaching hospital in the Netherlands. SAMPLE: 99 women with retained placenta (longer than 60 min after childbirth) in the absence of postpartum hemorrhage. METHODS: Eligible women were administered either 800 µg of misoprostol or placebo orally. MAIN OUTCOME MEASURES: Number of manual removals of retained placenta and amount of blood loss. RESULTS: Manual removal of retained placenta was performed in 50% of the women who received misoprostol and in 55% who received placebo (relative risk 0.91, 95% confidence interval 0.62-1.34). No difference in the amount of blood loss (970 vs. 1120 mL; p = 0.34) was observed between the two groups. CONCLUSIONS: Administration of 800 µg of oral misoprostol, one hour after childbirth, does not seem to reduce the number of manual removals of retained placentas. The time elapsing results in the delivery of 50% of the retained placentas at the expense of an increased risk of postpartum hemorrhage.

Vaginal misoprostol prior to insertion of an intrauterine device: an RCT.

BACKGROUND: Misoprostol is an agent that may ripen the cervix in nonpregnant women. Here, we investigate whether vaginal misoprostol administered prior to intrauterine device (IUD) insertion reduces the number of failed insertions, insertion-related complications and pain during insertion. METHODS: We conducted a double-blinded, multicenter randomized controlled trial among patients requesting an IUD. Nulli- and multi-parous women were included, and both copper-containing and levonorgestrel-releasing IUDs were used. Participants were allocated to either 400 µg misoprostol or placebo (administered 3h prior to IUD insertion). The primary outcome measure was failed insertion. Secondary outcome measures were insertion-related complications, pain, difficulty of insertion and side-effects. RESULTS: Two hundred and seventy participants were randomized. After drop out for various reasons (mainly no show), 199 participants had an IUD inserted; 102 received misoprostol and 97 received placebo. Only three insertions failed; two in the misoprostol group and one in the placebo group [P = 0.59, relative risk (RR) 1.9, 95% confidence interval (CI) 0.2-20.6]. The overall incidence of insertion-related complications was 21.8% in the misoprostol versus 19.1% in the placebo group (mainly vasovagal-like reactions) and did not differ between groups (P = 0.65, RR 1.1, 95% CI 0.7-2.0). No difference in pain scores between groups was found. Side-effects were more common in the misoprostol group (P = 0.05, RR 1.3, 95% CI 1.0-1.7). CONCLUSION: The study showed no benefit for use of misoprostol prior to IUD insertion. However, there is a tendency of possible harm regarding side-effects. Therefore, we would not recommend standard pretreatment with misoprostol. The trial was registered in the European Clinical Trials Database EudraCT 2006-006897-60.

Feasibility of nonselective testing for hemoglobinopathies in early pregnancy in The Netherlands.

OBJECTIVE: To examine the feasibility of standardized hemoglobinopathy (HBP) carrier testing for pregnant women in The Netherlands in addition to the standard anemia screening. METHODS: We assessed the prevalence of HBP in women at the time of the first pregnancy visit using both a prospective cohort (N = 703) and a retrospective series of women selected at random (N = 588). For the purpose of analysis, the population was divided into a high risk and a low risk group for HBP based on maternal ethnicity. Screening for HBP utilized standard screening tests for anemia, with additional high performance liquid chromatography (Variant II); molecular analysis was performed by Gap-polymerase chain reaction (Gap-PCR) and if necessary, direct sequencing and multiplex ligation-dependent probe amplification (MLPA). Family history was reported or collected from the medical records. RESULTS: ß-Globin defects were found in 3.9% of the total population (50/1291). The frequency in the high risk population was 5.6% (37/656), compared with 1.2% (6/501) in the low risk group. In the prospective study we found 30 HBP carriers, leading to testing of 16 partners and identification of two couples at risk. One affected child was born. Mean gestational age at the screening was 11.3 weeks with a standard deviation (SD) of 5.8. CONCLUSION: We found that the prevalence of HBP carriers is high enough in our population to warrant HBP testing for the entire multiethnic population in early pregnancy at the time of anemia screening. This is feasible as most women had their booking early in their first trimester.

National perinatal audit, a feasible initiative for the Netherlands!? A validation study.

OBJECTIVE: To explore the feasibility of a national perinatal audit organization. DESIGN: Validation study. SETTING: Three regions in the Netherlands. POPULATION: 228 cases of perinatal mortality. METHODS: Narratives of perinatal mortality cases were assessed by a panel of representatives of all perinatal care provider groups. 123 cases were assessed twice. Consensus was defined as 75% agreement. For the chance corrected agreement Cohen's kappa statistic was used. MAIN OUTCOME MEASURES: Consensus and the chance corrected agreement on three cause of death classifications. The presence or absence of substandard factors (SSF) with the care provider, the organization of care and the relation of the SSF with perinatal death. RESULTS: Consensus rates and chance corrected agreement for three cause of death classifications ranged from 92 to 96% and kappa 0.87 to kappa 0.93 (very good agreement), with comparable confidence intervals and similar values in the validation subset of 123 cases. On the presence of SSF at the level of the care provider consensus and chance corrected agreement was 68% and kappa 0.53 (moderate), with comparable values in the subset of 123 cases. Consensus for the relation between SSF at the level of the care provider and perinatal death was 81.4% and kappa 0.68 (good). CONCLUSION: Perinatal audit on a national level with relatively large audit groups with many different care providers is feasible.

Comparison of the direct antiglobulin test and the eluate technique for diagnosing haemolytic disease of the newborn.

OBJECTIVE: The direct antiglobulin test (DAT) is an important tool for identification of haemolytic disease of the newborn (HDN) caused by erythrocyte immunization. Although this test has been used for decades, accurate insights into its diagnostic properties and optimal use in the diagnosis of HDN are limited. We aimed to gain more insight into the diagnostic properties of the DAT for HDN by comparing it with erythrocyte eluate screening. DESIGN AND METHODS: DAT and erythrocyte eluate screening was performed in umbilical cord blood of neonates obtained from 317 consecutive deliveries. Clinical jaundice was scored 4-6 days after delivery for the determination of HDN. RESULTS: In 21 neonates a positive DAT and in 61 neonates a positive eluate screening was found, while only 4 cases of HDN were observed. For the overall population the positive predictive value (PPV) and specificity of the DAT for HDN were 10% and 93% respectively and in the population of neonates with abnormal post-partum jaundice population the PPV and specificity were both 100%. The DAT missed two cases of HDN. These missed cases were, however, positive in the erythrocyte eluate screening. CONCLUSION: The detection of clinically irrelevant ABO immunization limits the specificity of the DAT and eluate for HDN in ABO-incompatible pregnancies. For optimal use, the DAT should be requested only in cases of jaundice and be interpreted in the context of ABO-incompatibility. Finally, a negative DAT does not rule out HDN. When clinical suspicion is high, an eluate should be added following a negative DAT.

Measurement and significance of sperm morphology.

The measurement or evaluation and clinical significance of human sperm morphology has always been and still is a controversial aspect of the semen analysis for the determination of a male's fertility potential. In this review the background of the development of the evaluation criteria for sperm morphology will be discussed. Aspects of criticism on the strict criteria definition and use of the criteria for sperm morphology evaluation will be discussed as well as possible reasons for the decline in normal sperm morphology values and how we can compromise for this phenomenon resulting in the very low normal reference value as published in the 2010 WHO manual for the Examination and Processing of Human Semen. One of the possible solutions may be to give more attention to a limited number of abnormal sperm morphology categories and the inclusion of sperm morphology patterns. It is concluded in this review that if done correctly and with care and with strict application of existing guidelines as outlined in the 2010 WHO manual, sperm morphology measurement still has a very important role to play in the clinical evaluation of male fertility potential.