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Trial registered on ANZCTR


Registration number
ACTRN12613000141741
Ethics application status
Approved
Date submitted
31/01/2013
Date registered
6/02/2013
Date last updated
19/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and safety of a new device (Odon device) for assisted vaginal deliveries
Scientific title
In pregnant women, is the use of the Odon device during the second stage of labour feasible and safe for maternal and perinatal outcomes?
Secondary ID [1] 281873 0
A65711
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged second stage of labour 288255 0
Condition category
Condition code
Reproductive Health and Childbirth 288607 288607 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New device (Odon Device) to deliver the fetus. The Odon device is technological innovation to facilitate operative vaginal delivery. The Odon Device is made of two main components: a plastic sleeve and an inserter. The sleeve is made of flexible polyethylene, with an internal fold in contact with the fetal head and the external fold in contact with the vaginal wall.. The inserter consists of a handle with four pronged flexible spatulas that slide around the fetal head and help to position the sleeve
The device will be applied to women without labour complications under non-emergency/normal delivery conditions. The device is applied on second stage of labour (i.e. cervix fully dilated) and on a station level equivalent to 2 cm or more below the spines.
Intervention code [1] 286434 0
Treatment: Devices
Comparator / control treatment
No comparator is used. The device was tested for safety and feasibility in terms of ease of application and successful delivery under non-emergency/normal delivery conditions
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288758 0
Primary outcome 1: Time from application of device to delivery of the cephalic pole.
Timepoint [1] 288758 0
During labour and delivery
Primary outcome [2] 288759 0
Primary outcome 2: Failure rate of device application (only one attempt will be made)
Timepoint [2] 288759 0
During labour and delivery
Primary outcome [3] 288760 0
Primary outcome 3: Incidence of: (i) Operative delivery with forceps or vacuum; (ii) caesarean section
Timepoint [3] 288760 0
During labour and delivery
Secondary outcome [1] 300917 0
Time taken to apply the device (in seconds; from the start to the removal of the inserter)
Timepoint [1] 300917 0
During labour
Secondary outcome [2] 300959 0
Successful application and inflation
Timepoint [2] 300959 0
During labour
Secondary outcome [3] 300960 0
Any slipping of the device
Timepoint [3] 300960 0
During labour
Secondary outcome [4] 300961 0
Number of contractions after application
Timepoint [4] 300961 0
During labour
Secondary outcome [5] 300962 0
Integrity of the air chamber after expulsion. Assessment method: Once the device has been used and before discarding it, it is checked for integrity. The integrity of the air chamber is examine by pumping air into the chamber again and testing that there is not an air leak.
Timepoint [5] 300962 0
After delivery
Secondary outcome [6] 300963 0
Incidence of episiotomy
Timepoint [6] 300963 0
During delivery
Secondary outcome [7] 300964 0
Incidence of perineal lacerations including cervical laceration and incidence of third or fourth degree perineal tear
Timepoint [7] 300964 0
Immediate postpartum period
Secondary outcome [8] 300965 0
Incidence of uterine rupture
Timepoint [8] 300965 0
Immediate postpartum period
Secondary outcome [9] 300966 0
Incidence of pelvic, perineal or vaginal hematoma
Timepoint [9] 300966 0
Immediate postpartum period
Secondary outcome [10] 300967 0
Incidence of postpartum haemorrhage as routinely monitored at the centers
Timepoint [10] 300967 0
Immediate postpartum period
Secondary outcome [11] 300968 0
Incidence of postpartum endometritis or infection as routinely monitored at the centers
Timepoint [11] 300968 0
Immediate postpartum period
Secondary outcome [12] 300969 0
Incidence of maternal blood transfusion
Timepoint [12] 300969 0
Immediate postpartum period
Secondary outcome [13] 300970 0
Maternal pain during insertion of the device measured by a standardized questionnaire. Assessment method: The Visual Analoge Scale (VAS) will be used (from 0 to 10). Reference: Leeman L, Fullilove AM, Borders N, Manocchio R, Albers LL, Rogers RG.(2009) Postpartum perineal pain in a low episiotomy setting: association with severity of genital trauma, labor care, and birth variables. Birth. Dec;36(4):283-8.
Timepoint [13] 300970 0
At time of device application
Secondary outcome [14] 300971 0
Maternal satisfaction measured by a standardized questionnaire. Assessment method: Three closed questions were developed to assess maternal satisfaction with: (i) How do you feel about the information received on the Odon Device?; (ii) Are you satisfied with the Odon Device application? (iii) Do you think you might want to apply the Odon device again if you have another delivery?
Timepoint [14] 300971 0
Immediate postpartum period
Secondary outcome [15] 300972 0
Newborn respiratory rate at 3 or 6 hours. Assessment: By counting the number of breaths in one minute (by counting how many times the chest rises). It will be measured 3 hours after birth but if this couldn't be done, it will be measure at hour 6.
Timepoint [15] 300972 0
Immediate postpartum period
Secondary outcome [16] 300973 0
Incidence of birth trauma or injuries (skull fracture, caput succedaneum, cephalohematoma, cutaneous facial lesions and facial palsy, scalp, extracranial hemorrhages, subgaleal hemorrhage, subaponeurotic haemorrhage, intracranial injuries)
Timepoint [16] 300973 0
Immediate postpartum period
Secondary outcome [17] 300974 0
Incidence of low Apgar Scores (less than 7 at 1st minute and less than 7 at 5th minute)
Timepoint [17] 300974 0
Immediate postpartum period
Secondary outcome [18] 300975 0
Incidence of admission to Neonatal Intensive Care Unit and length of stay (> 7 days) in Neonatal Intensive Care Unit
Timepoint [18] 300975 0
Immediate postpartum period
Secondary outcome [19] 300976 0
Incidence of retinal hemorrhage as routinely diagnosed at the centers
Timepoint [19] 300976 0
Immediate postpartum period
Secondary outcome [20] 300977 0
Incidence of anaemia anemia as routinely diagnosed at the centers
Timepoint [20] 300977 0
Immediate postpartum period
Secondary outcome [21] 300978 0
Incidence of jaundice as routinely diagnosed at the centers
Timepoint [21] 300978 0
Immediate postpartum period
Secondary outcome [22] 300979 0
Evidence of infection by local standards as routinely diagnosed at the centers
Timepoint [22] 300979 0
Immediate postpartum period
Secondary outcome [23] 300980 0
Phototherapy
Timepoint [23] 300980 0
Immediate postpartum period
Secondary outcome [24] 300981 0
Incidence of fetal or neonatal death
Timepoint [24] 300981 0
Immediate postpartum period

Eligibility
Key inclusion criteria
- Age more or equal to 18 years, and less or equal 35 years
- Singleton pregnancy
- Gestational age equal to or more than 37 weeks
- Live fetus
- Fully dilated cervix
- Membranes ruptured (spontaneous or artificial).
- Any anterior occiput presentation.
- Station level equivalent to 2 cm or more below the spines
- Fetal Heart Rate Pattern recorded by continuous fetal electronic monitoring meeting the following criteria: (i) stable baseline rate between 110 and 160 beats/min, (ii) normal short and long term variability, (iii) absence of late decelerations.
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Suspected or confirmed maternal infection
- Prolonged rupture of membranes (>24 hours)
- Meconium stained
- History of coagulation disorder
- Previous uterine surgery
- Intrapartum hemorrhage
- Absolute cephalopelvic disproportion
- Known recto-vaginal Streptoccocus B Haemolyticcus positive culture
- Known HIV positive women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be approached during antenatal visits by a midwife who will explain the study objective and procedures. If the woman agrees to receive more information about the study, she will be fully briefed by a member of the study team who will review the consent form and show her the Odon device and how it functions. An explanatory video will also be made available. She will take the information home to think about it and discuss with family members if she wishes. She can sign the consent form when she returns for the next antenatal visit. Consent will be obtained before the initiation of labor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a medical device pilot trial and women are not randomized to the intervention.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Descriptive analysis will be carried out to show the frequencies of maternal and fetal complications, which will be reported as rates or means and 95% confidence intervals.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
After the 49th patient a decision was made by the company to end the pilot study in favor of a randomized pivotal clinical study
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4831 0
Argentina
State/province [1] 4831 0
Buenos Aires
Country [2] 10671 0
South Africa
State/province [2] 10671 0
Pretoria, Johannesburg and Cape Town
Country [3] 10672 0
Kenya
State/province [3] 10672 0
Nairobi

Funding & Sponsors
Funding source category [1] 286656 0
Other
Name [1] 286656 0
World Health Organization
Address [1] 286656 0
Avenue Appia 21
1211 Geneva 27
Country [1] 286656 0
Switzerland
Funding source category [2] 300184 0
Other
Name [2] 300184 0
Saving Lives at Birth: A Grand Challenge for Development Rounds 1 and 5
Address [2] 300184 0
Ronald Reagan Bldg and International Trade Center, 1300 Pennsylvania Ave NW, Washington, DC 20004
Country [2] 300184 0
United States of America
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 21
1211 Geneva 27
Country
Switzerland
Secondary sponsor category [1] 285435 0
None
Name [1] 285435 0
Address [1] 285435 0
Country [1] 285435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288728 0
WHO Research Ethics Review Committee (ERC)
Ethics committee address [1] 288728 0
Avenue Appia 21
1211 Geneva
Ethics committee country [1] 288728 0
Switzerland
Date submitted for ethics approval [1] 288728 0
Approval date [1] 288728 0
28/09/2010
Ethics approval number [1] 288728 0

Summary
Brief summary
Intrapartum complications are responsible for approximately half of all maternal deaths and two million stillbirth and neonatal deaths per year. Prolonged second stage of labor is associated with potentially fatal maternal complications and is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labor are cesarean section, forceps and vacuum extractor. All three clinical practices require relatively expensive equipment, highly trained staff that are often not available in low resource settings and, even if available, their use is associated with increased maternal and perinatal complications.

The specific aim of the proposed study is to test the safety and feasibility of a new device (Odon Device) to deliver the fetus during prolonged second stage of labor. The Odon device is a low cost, easy to use technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. This device may be potentially safer and easier to apply than forceps/vacuum extractor for assisted deliveries, and a safe alternative to some caesarean sections. If proven safe and effective, the Odon Device will be the first innovation in operative vaginal delivery since the independent development of forceps and the vacuum extractor centuries ago. The Odon device could play a major role in improving intrapartum obstetric care in low resource settings by making possible effective management of intrapartum complications in facilities lacking surgical capacity and/or personnel adequately trained in the use of forceps and the vacuum extractor.
Trial website
none
Trial related presentations / publications

Schvartzman JA, Krupitzki H, Merialdi M2, Betrán AP, Requejo J, Nguyen MH, Vayena E, Fiorillo AE1, Gadow EC, Vizcaino FM, von Petery F, Marroquin V, Cafferata ML, Mazzoni A, Vannevel V, Pattinson RC, Gülmezoglu AM, Althabe F, Bonet M; World Health Organization Odon Device Research Group. Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study. Reprod Health. 2018 Mar 12;15(1):45. doi: 10.1186/s12978-018-0485-8.

World Health Organization Odon Device Research Group1, Schvartzman JA, Krupitzki H, Betran AP, Requejo J, Bergel E, Fiorillo AE, Gadow EC, Vizcaino FM, von Petery F, Althabe F, Belizan J, Borruto F, Boulvain M, Di Renzo GC, Gülmezoglu M, Hofmeyr J, Judge K, Leung TY, Nguyen MH, Saugstad OD, Temmerman M, Treisser A, Vayena E, Merialdi M.
Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol.Reprod Health. 2013 Jul 2;10:33. doi: 10.1186/1742-4755-10-33.
Public notes

Contacts
Principal investigator
Name 37506 0
Dr Javier Schvartzman
Address 37506 0
Av. Galván 4102 1431FWO, Buenos Aires
Country 37506 0
Argentina
Phone 37506 0
+54 11 5299-0100
Fax 37506 0
Email 37506 0
javiers3003@hotmail.com
Contact person for public queries
Name 37507 0
Dr Mercedes Bonet
Address 37507 0
World Health Organization
Avenue Appia 21
1211 Geneva 27
Country 37507 0
Switzerland
Phone 37507 0
+411227913347
Fax 37507 0
+41797914171
Email 37507 0
bonetm@who.int
Contact person for scientific queries
Name 37508 0
Dr Mercedes Bonet
Address 37508 0
World Health Organization
Avenue Appia 21
1211 Geneva 27
Country 37508 0
Switzerland
Phone 37508 0
+411227913347
Fax 37508 0
+41797914171
Email 37508 0
bonetm@who.int

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary