NCT00629369

Brief Summary

Developing a method to maximize maternal expulsive effort should be of great value in reducing the number of cesarean section or instrumental deliveries. Various investigations have shown that use of an occlusal support device (OSD) increases the isometric strength of different muscle groups. The aim of our study was to investigate the role of an OSD in second stage pushing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
Last Updated

March 13, 2008

Status Verified

March 1, 2008

Enrollment Period

2 months

First QC Date

February 25, 2008

Last Update Submit

March 7, 2008

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • The duration of the second stage of labor.

    The duration of the second stage of labor.

Study Arms (2)

A

EXPERIMENTAL

subjects with Occlusion Support Device with active pushing in the second stage of labor

Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0

2

NO INTERVENTION

Subjects without Occlusal Support Device with active pushing in the second stage of labor

Interventions

Extra 3 mouth guard, Shock doctor mouth guard v3.0DEVICE

Dental mouthguard, molded for each individual patient when in labor. The device is put in the water then in microwave for one minute to soften the device. The device is then applied to the patient's mouth for over 10 seconds to mold it.

Also known as: extra 3 mouth guard (www.shieldsports.com), shock doctor mouth guard v3.0 (www.shockdoc.com)
A

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primipara
  • Term
  • Singleton
  • Cephalic presentation
  • Reactive fetal heart rate pattern
  • Functioning epidural anesthesia

You may not qualify if:

  • Medical or obstetrical complications including intrauterine growth restriction
  • Large for gestational age
  • Uterine anomaly
  • Uterine myomata
  • Pre-eclampsia
  • Diabetes mellitus
  • Fetal anomaly
  • Maternal heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

  • Matsuo K, Mudd JV, Kopelman JN, Atlas RO. Duration of the second stage of labor while wearing a dental support device: a pilot study. J Obstet Gynaecol Res. 2009 Aug;35(4):672-8. doi: 10.1111/j.1447-0756.2008.01010.x.

    PMID: 19751326DERIVED

Study Officials

  • Robert O Atlas, MD

    Mercy Medical Center, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 6, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 13, 2008

Record last verified: 2008-03

Locations

US(1)