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.
Studieoversikt
Detaljert beskrivelse
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
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Yariv Yogev, professor
- Telefonnummer: 9723-9377490
- E-post: yarivy@clalit.org.il
Studer Kontakt Backup
- Navn: Yariv Yogev
Studiesteder
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Petah tikva, Israel
- Rabin Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Rate of change in of the vas scores before and after using this device
Tidsramme: 24 months
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24 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Duration of breastfeeding
Tidsramme: 24 months
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24 months
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The rate of cessation of breastfeeding because of pain
Tidsramme: 24 months
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24 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Yariv Yogev, professor, Director, Division of obstetrics and delivery
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 0087-15-RMC
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