Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

The peripartum period involvement in the development of post-partum depression. A prospective cohort study.

PURPOSE: This study explores postpartum depression (PPD) in women who screened negative in mid-pregnancy to assess the impact of the peripartum period on the development of depressive symptoms. METHODS: A prospective cohort study was carried out in two facilities in Argentina. The Edinburgh postnatal depression scale (EPDS) scale was applied to pregnant women between weeks 20-24 gestation, and those screening negative (<10) were included in the cohort. Participants were followed up until the 4th week postpartum, when the EPDS was repeated. If positive, a semi-structured clinical interview was applied (MINI) to define the diagnosis. RESULTS: A total of 112 pregnant women were eligible for the follow-up. At the 4th week postpartum, 14 women (12.5%, CI 95% 7.0; 20.1) screened positive using a cutoff point of 10 or more in the EPDS. Of those screened positive in the EPDS, two participants (1.8%, CI 95% 0.2-6.3) had a Major Depressive Disorder. Newborn admission to the Intensive Care Unit, hospitalization of the newborn after discharge, abuse during childbirth, and lack of company during labor were identified as peripartum risk factors. CONCLUSIONS: This study reinforces the relevance of women and newborn mental health care during the hospitalization process surrounding peripartum. The women and newborn hospitalization process should be better explored to understand the contribution to PPD and design and test strategies to alleviate the impact of maternal depression.