Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.
- Schvartzman JA Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- Krupitzki H Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- Merialdi M UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland.
- Betrán AP UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland.
- Requejo J Partnership for Maternal, Newborn and Child Health, World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland.
- Nguyen MH UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland.
- Vayena E Department of Health Sciences and Technology, ETH Zurich, Auf der Mauer 17, 8092, Zurich, Switzerland.
- Fiorillo AE Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- Gadow EC Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- Vizcaino FM Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- von Petery F Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- Marroquin V Department of Obstetrics and Gynecology, Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC-IUC - CONICET), University Hospital, Av. Galván 4102 1431FWO, Buenos Aires, Argentina.
- Cafferata ML Instituto de Efectividad Clínica y Sanitaria (IECS - CONICET), Dr Emilio Ravignani 2024, C1414CPV, Buenos Aires, Argentina.
- Mazzoni A Instituto de Efectividad Clínica y Sanitaria (IECS - CONICET), Dr Emilio Ravignani 2024, C1414CPV, Buenos Aires, Argentina.
- Vannevel V SAMRC Maternal and Infant Health Care Strategies, Department of Obstetrics and Gynaecology, University of Pretoria, Pretoria, South Africa.
- Pattinson RC SAMRC Maternal and Infant Health Care Strategies, Department of Obstetrics and Gynaecology, University of Pretoria, Pretoria, South Africa.
- Gülmezoglu AM UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland.
- Althabe F Instituto de Efectividad Clínica y Sanitaria (IECS - CONICET), Dr Emilio Ravignani 2024, C1414CPV, Buenos Aires, Argentina.
- Bonet M UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, CH-1211, Geneva 27, Switzerland. bonetm@who.int.
- 2018-03-13
Published in:
- Reproductive health. - 2018
Instrumental vaginal delivery
Odon device
Second stage of labour
Adult
Argentina
Cervix Uteri
Extraction, Obstetrical
Female
Humans
Perineum
Pilot Projects
Pregnancy
Pregnancy Outcome
Proof of Concept Study
South Africa
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12978-018-0485-8
- PMID 29526165
- Persistent URL
- https://folia.unifr.ch/global/documents/223717
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