The effectiveness of immediate versus delayed tubal flushing with oil-based contrast in women with unexplained infertility (H2Oil-timing study): study protocol of a randomized controlled trial.

BACKGROUND: In women with unexplained infertility, tubal flushing with oil-based contrast during hysterosalpingography leads to significantly more live births as compared to tubal flushing with water-based contrast during hysterosalpingography. However, it is unknown whether incorporating tubal flushing with oil-based contrast in the initial fertility work-up results to a reduced time to conception leading to live birth when compared to delayed tubal flushing that is performed six months after the initial fertility work-up. We also aim to evaluate the effectiveness of tubal flushing with oil-based contrast during hysterosalpingography versus no tubal flushing in the first six months of the study. METHODS: This study will be an investigator-initiated, open-label, international, multicenter, randomized controlled trial with a planned economic analysis alongside the study. Infertile women between 18 and 39 years of age, who have an ovulatory cycle, who are at low risk for tubal pathology and have been advised expectant management for at least six months (based on the Hunault prediction score) will be included in this study. Eligible women will be randomly allocated (1:1) to immediate tubal flushing (intervention) versus delayed tubal flushing (control group) by using web-based block randomization stratified per study center. The primary outcome is time to conception leading to live birth with conception within twelve months after randomization. We assess the cumulative conception rate at six and twelve months as two co-primary outcomes. Secondary outcomes include ongoing pregnancy rate, live birth rate, miscarriage rate, ectopic pregnancy rate, number of complications, procedural pain score and cost-effectiveness. To demonstrate or refute a shorter time to pregnancy of three months with a power of 90%, a sample size of 554 women is calculated. DISCUSSION: The H2Oil-timing study will provide insight into whether tubal flushing with oil-based contrast during hysterosalpingography should be incorporated in the initial fertility work-up in women with unexplained infertility as a therapeutic procedure. If this multicenter RCT shows that tubal flushing with oil-based contrast incorporated in the initial fertility work-up reduces time to conception and is a cost-effective strategy, the results may lead to adjustments of (inter)national guidelines and change clinical practice. TRIAL REGISTRATION NUMBER: The study was retrospectively registered in International Clinical Trials Registry Platform (Main ID: EUCTR2018-004153-24-NL).

Mode of childbirth and neonatal outcome after external cephalic version: A prospective cohort study.

OBJECTIVE: to assess the mode of childbirth and adverse neonatal outcomes in women with a breech presentation with or without an external cephalic version attempt, and to compare the mode of childbirth among women with successful ECV to women with a spontaneous cephalic presentation. DESIGN: prospective matched cohort study. SETTING: 25 clusters (hospitals and its referring midwifery practices) in the Netherlands. Data of the Netherlands perinatal registry for the matched cohort. PARTICIPANTS: singleton pregnancies from January 2011 to August 2012 with a fetus in breech presentation and a childbirth from 36 weeks gestation onwards. Spontaneous cephalic presentations (selected from national registry 2009 and 2010) were matched in a 2:1 ratio to cephalic presentations after a successful version attempt. Matching criteria were maternal age, parity, gestational age at childbirth and fetal gender. Main outcomes were mode of childbirth and neonatal outcomes. MEASUREMENTS AND FINDINGS: of 1613 women eligible for external cephalic version, 1169 (72.5%) received an ECV attempt. The overall caesarean childbirth rate was significantly lower compared to women who did not receive a version attempt (57% versus 87%; RR 0.66 (0.62-0.70)). Women with a cephalic presentation after ECV compared to women with a spontaneous cephalic presentation had a decreased risk for instrumental vaginal childbirth (RR 0.52 (95% CI 0.29-0.94)) and an increased risk of overall caesarean childbirth (RR 1.7 (95%CI 1.2-2.5)). KEY CONCLUSIONS: women who had a successful ECV are at increased risk for a caesarean childbirth but overall, ECV is an important tool to reduce the caesarean rate. IMPLICATION FOR PRACTICE: ECV is an important tool to reduce the caesarean section rates.

Risk of developmental dysplasia of the hip in breech presentation: the effect of successful external cephalic version.

OBJECTIVE: To evaluate the effect of successful external cephalic version on the incidence of developmental dysplasia of the hip (DDH) requiring treatment in singleton breech presentation at term. DESIGN: Observational cohort study. SETTING: Three large teaching hospitals in the Netherlands. POPULATION: Women with a singleton breech presentation of 34 weeks of gestation or more, who underwent an external cephalic version attempt. METHODS: We made a comparison of the incidence of DDH between children born in breech presentation and children born in cephalic presentation after a successful external cephalic version. MAIN OUTCOME MEASURE: The incidence of DDH requiring either conservative treatment, with a harness, or surgical treatment. RESULTS: A total of 498 newborns were included in the study, of which 40 (8%) were diagnosed with DDH and 35 required treatment. Multivariate analysis showed that female gender (OR 2.79, 95% CI 1.23-6.35) and successful external cephalic version (OR 0.29, 95% CI 0.09-0.95) were independently associated with DDH. CONCLUSIONS: A successful external cephalic version is associated with a lower incidence of DDH, although a high percentage of children born after a successful external cephalic version still appear to have DDH. A larger cohort study is needed to establish the definite nature of this relationship. Until then, we recommend the same screening policy for infants born in cephalic position after a successful external cephalic version as for infants born in breech position.

Risk factors for developmental dysplasia of the hip: a meta-analysis.

Early detection and subsequent treatment of developmental dysplasia of the hip (DDH) is thought to improve its prognosis. Frequently reported risk factors for DDH are a positive family history of DDH, female sex and breech presentation, but there is not a lot of systematic knowledge about DDH risk factors. We performed a systematic review and meta-analysis of the available evidence on DDH risk factors. We searched Medline, EMBASE and The Cochrane Library from conception up until October 2011 for primary articles on the subject. All studies reporting on potential risk factors for DDH that allowed construction of a two-by-two table were selected. Language restrictions were not applied. Two reviewers independently selected studies, extracted data and assessed study quality. The association between risk factors and DDH was expressed as a common odds ratio (OR) with a 95% confidence interval (CI). We identified 30 relevant studies reporting on 1,494,387 children; 26 studies were cohort studies and four studies used a case-control design. The risk of DDH was strongly increased in case of breech delivery (OR 5.7, 95% CI 4.4-7.4), female sex (OR 3.8, 95% CI 3.0-4.6) a positive family history of DDH (OR 4.8, 95% CI 2.8-8.2) and clicking hips at clinical examination (OR 8.6, 95% CI 4.5-16.6). This meta-analysis shows that infants born in breech presentation, female infants, infants with a positive family history and clicking hips at clinical examination have an increased risk for DDH. This knowledge can be helpful in the development of screening programs for DDH.