Second Stage of Labor
Conditions
Keywords
dental support, second stage of labor
Brief summary
To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.
Detailed description
Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery. The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. We hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. We will also investigate it's efficiency in pain management.
Interventions
DEVICEreceive Laboraide
After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package. Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire.
Sponsors
Yariv yogev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Singleton gestation 2. Multiparous women 3. Term gestation (\>37+0/7 weeks) 4. Signed written consent to participate in the study 5. Maternal age 18-45 years 6. Normal vital signs 7. Noraml cardiotocography and biophysical profile at admission
Exclusion criteria
1. Multiple gestation 2. Nulliparous women 3. preterm gestation (\<37+0/7 weeks) 4. Refusal to participate 5. Maternal age \<18 or \> 45 years 6. Normal vital signs 7. Abnormal cardiotocography and biophysical profile at admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the second stage of labor. | 12 month | After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package. Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire. |
| Mode of delivery. | 12 month | After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package. Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire. |
| VAS pain score. | 12 month | After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package. Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire. |
Countries
Israel
Contacts
Primary ContactYariv Yogev, professor
Outcome results
None listed