Dental Support Device During Breastfeeding as a Mean for Pain Control
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Studie Overzicht
Gedetailleerde beschrijving
Dental support device is effective in increasing isometric force in different muscle contraction [1-7]. In 2009 an avant-garde study [8] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Yariv Yogev, professor
- Telefoonnummer: 9723-9377490
- E-mail: yarivy@clalit.org.il
Studie Contact Back-up
- Naam: Yariv Yogev
Studie Locaties
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Petah tikva, Israël
- Rabin Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Maternal age 18-45 years.
- Normal vital signs.
Exclusion Criteria:
- Contraindications for breastfeeding.
- Significant systemic disease that cause pain or require chronic pain relief.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Post-partum women that have already begun breast feeding
2. Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device.
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Experimenteel: Post-partum primi and multiparous women
Post-partum primipara and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Rate of change in of the vas scores before and after using this device
Tijdsspanne: 24 months
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24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Duration of breastfeeding
Tijdsspanne: 24 months
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24 months
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The rate of cessation of breastfeeding because of pain
Tijdsspanne: 24 months
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24 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yariv Yogev, professor, Director, Division of obstetrics and delivery
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 0087-15-RMC
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