Dental Support and the Second Stage of Labor Among Multiparous Women

NCT ID: NCT02344914

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Second Stage of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

receive Laboraide

Intervention Type: DEVICE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yariv yogev

OTHER

Sponsor Role: lead

Responsible Party

Yariv yogev

Yariv Yogev, professor Director, division of obstetrics and delivery ward

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yariv Yogev, professor

Role: PRINCIPAL_INVESTIGATOR

Director, Division of obstetrics and delivery

Locations

Rabin Medical Center

Petah Tikva, Israel, Israel

Rabin Medical Center

Petah Tikva, Israel, Israel

Countries

Israel

Central Contacts

Yariv Yogev, professor

Role: CONTACT

yarivy@clalit.org.il

9723-9377490

Facility Contacts

Yariv Yogev, professor

Role: primary

yarivy@clalit.org.il

Yariv Yogev, prof

Role: primary

yarivy@clalit.org.il

Other Identifiers

0523-14-RMC

Identifier Type: -

Identifier Source: org_study_id