Dental Support and the Second Stage of Labor Among Multiparous Women

Second Stage of Labor Clinical Trial

Official title:

Dental Support and the Second Stage of Labor Among Multiparous Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02642120
• Other study ID #: 0558-15- TLV
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 21, 2015
• Last updated: December 29, 2015
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ariel many, professor
• Phone: 052-4266954
• Email: arielm[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Second Stage of Labor

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the second stage of labor.	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.	12 month	No
Secondary	Patient satisfaction (questionnaire)	Following delivery, patients will be asked to complete a satisfaction questionnaire.	12 month	No