Dental Support and the Second Stage of Labor Among Multiparous Women

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3

Conditions: Second Stage of Labor

Treatments: Device: Dental device "Laboraide"

Study type: Interventional

Funder types: Other

Identifiers

NCT02642120

0558-15- TLV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Receive Laboraide

Experimental group

Description:

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.

Treatment:

Device: Dental device "Laboraide"

Do not receive Laboraide

No Intervention group

Description:

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.