Single deepest vertical pocket or amniotic fluid index as evaluation test for predicting adverse pregnancy outcome (SAFE trial): a multicenter, open-label, randomized controlled trial.

OBJECTIVE: To determine whether the amniotic fluid index (AFI) or the single deepest vertical pocket (SDP) technique for estimating amniotic fluid volume is superior for predicting adverse pregnancy outcome. METHODS: This was a multicenter randomized controlled trial including 1052 pregnant women with a term singleton pregnancy across four hospitals in Germany. Women were assigned randomly, according to a computer-generated allocation sequence, to AFI or SDP measurement for estimation of amniotic fluid volume. Oligohydramnios was defined as AFI ≤ 5 cm or the absence of a pocket measuring at least 2 × 1 cm. The diagnosis of oligohydramnios was followed by labor induction. The primary outcome measure was postpartum admission to a neonatal intensive care unit. Further outcome parameters were the rates of diagnosis of oligohydramnios and induction of labor (for oligohydramnios or without specific indication), and mode of delivery. RESULTS: Postpartum admission to a neonatal intensive care unit was similar between groups (4.2% (n = 21) vs 5.0% (n = 25); relative risk (RR), 0.85 (95% CI, 0.48-1.50); P = 0.57). In the AFI group, there were more cases of oligohydramnios (9.8% (n = 49) vs 2.2% (n = 11); RR, 4.51 (95% CI, 2.2-8.57); P < 0.01) and more cases of labor induction for oligohydramnios (12.7% (n = 33) vs 3.6% (n = 10); RR, 3.50 (95% CI, 1.76-6.96); P < 0.01) than in the SDP group. Moreover, an abnormal cardiotocography was seen more often in the AFI group than in the SDP group (32.3% (n = 161) vs 26.2% (n = 132); RR, 1.23 (95% CI, 1.02-1.50); P = 0.03). The other outcome measures were not significantly different between the two groups. CONCLUSIONS: Use of the AFI method increased the rate of diagnosis of oligohydramnios and labor induction for oligohydramnios without improving perinatal outcome. The SDP method is therefore the favorable method to estimate amniotic fluid volume, especially in a population with many low-risk pregnancies. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Sequential use of double-balloon catheter and oral misoprostol versus oral misoprostol alone for induction of labour at term (CRBplus trial): a multicentre, open-label randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of inducing labour using a double-balloon catheter and oral misoprostol sequentially, in comparison with oral misoprostol alone. DESIGN: A multicentre randomised controlled trial. SETTING: Five hospitals in Germany. POPULATION: A total of 326 pregnant women with an unfavourable cervix undergoing labour induction at term. METHODS: Women were randomly assigned according to a computer-generated allocation sequence to sequential use of double-balloon catheter and oral misoprostol (study group) or oral misoprostol alone (control group). In the study group, the double-balloon catheter was used the first day before starting oral misoprostol the second day. MAIN OUTCOME MEASURES: The primary outcome measure was the induction-to-delivery interval, and a further outcome parameter was delivery within 48 hours. RESULTS: The median times for induction of labour until delivery were 32.4 hours in the study group and 22.5 hours in the control group (P = 0.004). This difference was not seen when evaluating according to parity (nulliparous, P = 0.19; parous, P = 0.06). The rate of vaginal delivery within 48 hours did not differ between both groups. The number of applications of misoprostol (two versus three, P < 0.001) and the dose of misoprostol used was lower in the study group (100 versus 200 µg, P < 0.001). In the study group, there were more Apgar scores of <7 at 5 minutes (8 versus 1, P = 0.04). CONCLUSIONS: The use of a double-balloon catheter on the first day, before starting oral misoprostol on the second day, did not improve the induction to delivery interval and the rate of delivery within 48 hours, in comparison with oral misoprostol alone.

Gynaecological laparoscopic surgery for benign conditions: do women care about incisions?

OBJECTIVE: To determine the relevance of the number and location of incisions in women undergoing gynaecologic laparoscopy due to benign conditions. STUDY DESIGN: This study included 141 women, who underwent gynaecologic laparoscopic surgery with 4 incisions due to benign conditions between November 2010 and November 2011 at the University Medical Centre Mannheim, Germany. Women with malign histology were excluded. Demographic parameters, type and duration of surgery, perioperative complications and duration of hospital stay were analysed. Women were contacted using a standardized telephone survey with an interval of at least 22 weeks after surgery. Patients were interviewed regarding the number, postoperative pain and their preferences for omission of incisions. RESULTS: Eighty-seven women (61.7%) responded to the standardized questionnaire. 38 (43.7%) remembered the number of incisions correctly. 45 of the women (51.7%) thought they had less, 4 (4.6%) thought, they had more incisions as they actually did have. If one of the incisions had to be discarded 28 (32.2%) patients did not have any preferences with regard to the localisation. Of the other 59 patients, 44 (74.6%) would prefer to eliminate the umbilical one. CONCLUSION: The majority of the women remembered fewer incisions than actually used. Most of the patients interviewed would, if possible, eliminate the umbilical incision. Therefore from the patient's perspective the skin scars after conventional laparoscopic surgery seem to be of limited importance and the alleged advantage of omission of additional incision using single site surgery remains debatable.

[Expectations of pregnant women on an ideal maternity hospital]. / Welche Erwartungen stellen Schwangere an eine ideale Entbindungsklinik?

PURPOSE: The aim of this study was to evaluate expectations of pregnant women on an ideal maternity hospital. MATERIAL AND METHODS: We prospectively performed a survey among 566 pregnant women with regard to their expectations on a perfect hospital for obstetrics. Data collection was accomplished in 3 obstetrical departments in Mannheim, Germany. The questionnaire contained 23 general questions about sociodemographic characteristics and 34 specific questions about the anticipated childbirth. Women who were less than 20 weeks pregnant and women who did not speak German fluently were excluded from this study. RESULTS: In our survey the possibility to get to know midwifes and doctors at information evenings and a guided delivery room tour were defined as very important factors by the interviewed women. Of particular importance was a continuous care by a single midwife and the physical attendance of a family member during childbirth. Furthermore, friendliness of the staff and medical care by paediatricians after childbirth were identified to be important. To some extent, a modern appearance of the ward was also a matter of importance. CONCLUSIONS: The medical treatment of mother and the newborn child and the friendliness of the staff have been identified as the most important factors with regard to the expectations of women on an ideal maternity hospital. In addition, a pleasant ambiance of the ward and regular visits by a lactation specialist were named as important.