Dental Support Device During Breastfeeding as a Mean for Pain Control
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: women whom are interested in breastfeeding and have not begun. 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 Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding. Control group: participants will not receive any device for breastfeeding pain control |
Device: dental device
Leboride
Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
Control group: participants will not receive any device for breastfeeding pain control
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.
|
| Experimental: 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. |
Device: dental device
Leboride
Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
Control group: participants will not receive any device for breastfeeding pain control
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.
|
Outcome Measures
Primary Outcome Measures
- Rate of change in of the vas scores before and after using this device [24 months]
Secondary Outcome Measures
- Duration of breastfeeding [24 months]
- The rate of cessation of breastfeeding because of pain [24 months]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tel-Aviv Sourasky Medical Center
Investigators
- Principal Investigator: Ariel many, professor, Tel Aviv Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 559-15-TLV