An evaluation of patient comfort levels during expression with a modified pumping program: a prospective proof of concept study.

Introduction: This study aimed to assess if the implementation of a gentle transition of vacuum mode into a breast pump suction pattern commonly used to initiate milk production would improve user comfort while expressing during the first four days postpartum. Methods: This prospective study was conducted at OLVG hospital in the Netherlands in two sequential phases. Breastfeeding patients delivering >36 weeks gestation with an infant aged ≤96 h old and a clinical indication to express milk with a breast pump were recruited. Intervention group 1 (n = 40) used a hospital-grade electric breast pump with a standard breast pump suction pattern. Intervention group 2 used a hospital-grade electric breast pump with a modified breast pump suction pattern (n = 40). The primary outcome was an objective assessment of comfort as measured by participants' need to reduce vacuum level during the 20 min test session. Secondary outcomes included the total expression volume (ml) in 20 min pumping. Results: The study found that the primary outcome of comfort was significantly improved with the modified breast pump suction pattern compared to the standard pattern (OR 1.29, 95% CI 1.08 to 1.6) with 86% vs. 67% of participants not needing to reduce applied vacuum levels. The amount of milk expressed did not differ significantly between phases (group 1: 7.6 ml (2.7-25.5 ml), group 2: 12.0 ml (1.2-31.5 ml), p = 0.43). Discussion: This study is the first to demonstrate an improvement in user comfort driven by the implementation of gentle transitions in vacuum modes in a commonly used breast pump suction pattern. Research into this novel population combining both pumping and breastfeeding in the first days after birth offers new unique insights on the requirements of breast pump suction patterns. Trial registration: Registered on clinical trials.gov NCT04619212. Date of registration November 6, 2020.

Breech deliveries in OLVG, the Netherlands: A retrospective cohort study of seven years.

BACKGROUND: The clinical dilemma on the preferred mode of delivery for breech position still exists. Elective caesarean delivery (CD) could be safer for neonates, whereas vaginal breech delivery (VBD) remains a safe option when conducted by an experienced person. Besides successful VBD is beneficial for mothers and subsequent pregnancies. OBJECTIVES: To evaluate breech deliveries on mode of delivery, maternal and neonatal outcomes. STUDY DESIGN: A single center, retrospective, cohort study was performed of women who delivered a singleton fetus in breech position from 32 weeks' gestation onwards from January 2011 to December 2017. Primary outcome measure was mode of delivery defined as an elective CD and planned VBD. Secondary outcome measures were neonatal and maternal outcome. For neonatal outcome, we used neonatal mortality and a composite measure neonatal morbidity. Maternal outcome included maternal mortality and maternal morbidity divided in severe and non-severe complications. We subcategorized for preterm (32 weeks to 37 weeks of gestation) and term pregnancies (from 37 weeks of gestation onwards). RESULTS: 1.774 women delivered a child in breech position, 73 % opted for an elective CD. Of the 484 women that had a planned VBD (preterm 38 % (n = 59), term 26 % (n = 425)) 71 % were successful. Neonatal mortality occurred twice in the VBD cohort. Preterm neonatal morbidity occurred in the elective CD and VBD cohort equally (both 66 %), at term significantly more in the VBD cohort (12 % v 4%, OR 3.2, 95 % CI 2.1-4.8). For the total cohort, severe maternal postpartum complications occurred more often in the elective CD compared to successful VBD (2% v 0.3 %, OR 6.0, 95 % CI 0.80-44.3). CONCLUSION: A high rate of successful VBD after opting for a planned VBD was found in our center. Nevertheless, compromised neonatal outcome at term was more frequent in the planned VBD group compared to the elective CD group. Severe maternal postpartum complications were more frequent in the elective CD group compared to the VBD group. Future research should focus alternations in the management of breech presentation.

Perinatal outcomes according to the mode of delivery in women with a triplet pregnancy in The Netherlands.

Objective: In women with a triplet pregnancy, there is debate on the preferred mode of delivery. We performed a nationwide cohort study to assess the impact of mode of delivery on perinatal outcome in women with a triplet pregnancy. Methods: Nationwide cohort study on women with a triplet pregnancy who delivered between 26 + 0 and 40 + 0 weeks of gestation in the years 1999-2008. We compared perinatal outcomes according to the intended mode of delivery and the actual mode of delivery. Outcome measures were perinatal mortality and neonatal morbidity. Perinatal outcomes were analyzed taking into account the dependency between the children of the same triplet pregnancy ("any mortality" and "any morbidity") and were also analyzed separately per child. Results: We identified 386 women with a triplet pregnancy in the study period. Mean gestational age at delivery was 33.1 weeks (SD 2.5 weeks; range 26.0-40.0 weeks). Perinatal mortality was 2.3% for women with a planned caesarean section and 2.4% in women with a planned vaginal delivery (aOR 0.37; 95% confidence interval (CI) 0.09-1.5) and neonatal morbidity was 26.0% versus 36.0%, (aOR 0.88; 95% CI 0.51-1.4) respectively. In the subgroup analyses according to gestational age and in the analysis of perinatal outcomes per child separately, there were also no large differences in perinatal outcomes. The same applied for perinatal outcomes according to the actual mode of delivery. Conclusion: In this large cohort study among women with a triplet pregnancy, caesarean delivery is not associated with reduced perinatal mortality and morbidity.

Development and internal validation of a clinical prediction model for external cephalic version.

OBJECTIVE: To develop a prediction model for the chance of successful external cephalic version (ECV). STUDY DESIGN: This is a secondary analysis of a multicenter, open-label randomized controlled trial that assessed the effectiveness of atosiban compared to fenoterol as uterine relaxant during ECV in women with a singleton fetus in breech presentation with a gestational age of 36 weeks or more. Potential predictors included maternal, pregnancy, fetal, and treatment characteristics and were recorded in all participants. Multivariable logistic regression analysis with a stepwise backward selection procedure was used to construct a prediction model for the occurrence of successful ECV. Model performance was assessed using calibration and discrimination. RESULTS: We included a total of 818 women with an overall ECV success rate of 37%. Ten predictive factors were identified with the stepwise selection procedure to be associated with a successful ECV: fenoterol as uterine relaxant, nulliparity, Caucasian ethnicity, gestational age at ECV, Amniotic Fluid Index, type of breech presentation, placental location, breech engagement, possibility to palpate the head and relaxation of the uterus. Our model showed good calibration and a good discriminative ability with a c-statistic of 0.78 (95% CI 0.75 to 0.81). CONCLUSION: Prediction of success of ECV seems feasible with a model showing good performance. This can be used in clinical practice after external validation.

Atosiban versus fenoterol as a uterine relaxant for external cephalic version: randomised controlled trial.

OBJECTIVE:  To compare the effectiveness of the oxytocin receptor antagonist atosiban with the beta mimetic fenoterol as uterine relaxants in women undergoing external cephalic version (ECV) for breech presentation. DESIGN:  Multicentre, open label, randomised controlled trial. SETTING:  Eight hospitals in the Netherlands, August 2009 to May 2014. PARTICIPANTS:  830 women with a singleton fetus in breech presentation and a gestational age of more than 34 weeks were randomly allocated in a 1:1 ratio to either 6.75 mg atosiban (n=416) or 40 µg fenoterol (n=414) intravenously for uterine relaxation before ECV. MAIN OUTCOME MEASURES:  The primary outcome measures were a fetus in cephalic position 30 minutes after the procedure and cephalic presentation at delivery. Secondary outcome measures were mode of delivery, incidence of fetal and maternal complications, and drug related adverse events. All analyses were done on an intention-to-treat basis. RESULTS:  Cephalic position 30 minutes after ECV occurred significantly less in the atosiban group than in the fenoterol group (34% v 40%, relative risk 0.73, 95% confidence interval 0.55 to 0.93). Presentation at birth was cephalic in 35% (n=139) of the atosiban group and 40% (n=166) of the fenoterol group (0.86, 0.72 to 1.03), and caesarean delivery was performed in 60% (n=240) of women in the atosiban group and 55% (n=218) in the fenoterol group (1.09, 0.96 to 1.20). No significant differences were found in neonatal outcomes or drug related adverse events. CONCLUSIONS:  In women undergoing ECV for breech presentation, uterine relaxation with fenoterol increases the rate of cephalic presentation 30 minutes after the procedure. No statistically significant difference was found for cephalic presentation at delivery. TRIAL REGISTRATION:  Dutch Trial Register, NTR 1877.

Prediction models for successful external cephalic version: a systematic review.

To provide an overview of existing prediction models for successful ECV, and to assess their quality, development and performance. We searched MEDLINE, EMBASE and the Cochrane Library to identify all articles reporting on prediction models for successful ECV published from inception to January 2015. We extracted information on study design, sample size, model-building strategies and validation. We evaluated the phases of model development and summarized their performance in terms of discrimination, calibration and clinical usefulness. We collected different predictor variables together with their defined significance, in order to identify important predictor variables for successful ECV. We identified eight articles reporting on seven prediction models. All models were subjected to internal validation. Only one model was also validated in an external cohort. Two prediction models had a low overall risk of bias, of which only one showed promising predictive performance at internal validation. This model also completed the phase of external validation. For none of the models their impact on clinical practice was evaluated. The most important predictor variables for successful ECV described in the selected articles were parity, placental location, breech engagement and the fetal head being palpable. One model was assessed using discrimination and calibration using internal (AUC 0.71) and external validation (AUC 0.64), while two other models were assessed with discrimination and calibration, respectively. We found one prediction model for breech presentation that was validated in an external cohort and had acceptable predictive performance. This model should be used to council women considering ECV.

A nationwide survey concerning practices in pessary use for pelvic organ prolapse in The Netherlands: identifying needs for further research.

INTRODUCTION AND HYPOTHESIS: To identify practice variation in management of patients with a vaginal pessary for pelvic organ prolapse (POP). METHODS: A nationwide survey was sent to all Dutch gynecologists with a special interest in urogynecology. RESULTS: The response rate was 59 %. Of the respondents, 13 % had a written protocol for pessary treatment in their department. Pessary treatment was proposed by 69 % of respondents as a treatment option. Counseling about side effects varied. All respondents provided information concerning the possibility of serious vaginal discharge. Concerning this side effect, 15 % of the respondents stated that it occurs in 5 - 20 % of patients, 27 % that it occurs in 20 - 40 % of patients, and 57 % that it occurs in more than 40 % of patients. Another item concerned counseling for the likelihood of vaginal blood loss. All respondents provided information concerning the possibility of vaginal blood loss. Concerning this side effect, 53 % of the respondents stated that it occurs in 5 - 20 % of patients, 33 % that it occurs in 20 - 40 %, and 14 % that it occurs in more than 40 % of patients. Follow-up after initial placement was done by 69 % of the respondents at 2 - 6 weeks, by 2 % at 8 weeks, and by 29 % at 12 weeks or more. Most (98 %) of the respondents extended the interval between visits when the patient had no complaints, and 96 % of the respondents reported that they routinely instruct patients about self-management. CONCLUSIONS: Pessaries are suggested as a treatment option by a majority of gynecologists, but practice varies widely. We consider that the variation in practice is due to a lack of available protocols and lack of evidence.

Mode of delivery after successful external cephalic version: a systematic review and meta-analysis.

OBJECTIVE: To assess the mode of delivery in women after a successful external cephalic version by performing a systematic review and meta-analysis. DATA SOURCES: We searched MEDLINE, Embase, ClinicalTrials.gov, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library for studies reporting on the mode of delivery in women after successful external cephalic version at term and women with a spontaneous cephalic-presenting fetus. METHODS OF STUDY SELECTION: Two reviewers independently selected studies, extracted data, and assessed study quality. The association between mode of delivery and successful external cephalic version was expressed as a common odds ratio with a 95% confidence interval (CI). TABULATION, INTEGRATION, AND RESULTS: We identified three cohort studies and eight case-control studies, reporting on 46,641 women. The average cesarean delivery rate for women with a successful external cephalic version was 21%. Women after successful external cephalic version were at increased risk for cesarean delivery for dystocia (odds ratio [OR] 2.2, 95% CI 1.6-3.0), cesarean delivery for fetal distress (OR 2.2, 95% CI 1.6-2.9), and instrumental vaginal delivery (OR 1.4, 95% CI 1.1-1.7). LEVEL OF EVIDENCE: Women who have had a successful external cephalic version for breech presentation are at increased risk for cesarean delivery and instrumental vaginal delivery as compared with women with a spontaneous cephalic presentation. Nevertheless, with a number needed to treat of three, external cephalic version still remains a very efficient procedure to prevent a cesarean delivery.