Dental Support and the Second Stage of Labor Among Multiparous Women
NCT ID: NCT02642120
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2016-01-31
2018-01-31
Brief Summary
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Detailed Description
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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. The investigators hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. The researchers will also investigate it's efficiency in pain management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Receive 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.
Dental device "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.
Do not receive 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 control group.
No interventions assigned to this group
Interventions
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Dental device "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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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michal roll
Deputy Director General for R&D
Principal Investigators
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Ariel many, professor
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center
Central Contacts
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Other Identifiers
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0558-15- TLV
Identifier Type: -
Identifier Source: org_study_id