NCT00506116

Brief Summary

The purpose of this study is to determine whether pushing during labor that is controlled by the woman results in less birth-related injury and less postpartum urinary incontinence (UI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 1996

Longer than P75 for phase_3

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

July 1, 1996

Completed
10.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
Last Updated

July 31, 2007

Status Verified

May 1, 2007

First QC Date

July 23, 2007

Last Update Submit

July 30, 2007

Conditions

Urinary IncontinencePelvic Organ ProlapsePerinatal LacerationSecond Stage Labor

Keywords

Pelvic floor muscle trainingSelf-directed pushingAntenatal perineal massage

Outcome Measures

Primary Outcomes (1)

  • Leakage Index (

    20 and 35 weeks gestation, and 6 weeks, 6 months, and 12 months postpartum

Secondary Outcomes (2)

  • Perineal status (Digital, speculum, chart review, ultrasound)

    35 week gestation and 6 weeks, 6 months, and 12 months postpartum

  • Pelvic Organ Prolapse Quantification System (POPQ)

    35 weeks gestation and 6 weeks, 6 months, and 12 months postpartum

Interventions

Videotape, routine care, PME instructionBEHAVIORAL

A 40 minute videotape about non-directed, spontaneous pushing and/or a videotape of antenatal perineal massage and pelvic muscle exerise (PME) at intake visit. The control women received routine care and PME instruction at intake visit.

PME practice and record keeping (in diaries)BEHAVIORAL
Non-directed or directed,spontaneous or sustained pushingBEHAVIORAL

Non-directed, spontaneous pushing (experimental group) with perineal massage vs. directed, sustained pushing during delivery.

Data collectionPROCEDURE

Baseline at 20 weeks gestation; longitudinal at 35 weeks gestation, 6 weeks postpartum, 6 months postpartum, and 12 months postpartum

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women giving birth for the first time who are:
  • Age 18 years or older
  • Less than 20 weeks gestation
  • Expected vaginal birth without use of epidural analgesia
  • Plan to reside in Southeast Michigan for one year following the birth of the infant.

You may not qualify if:

  • History of genito-urinary or neuro-muscular pathology
  • Previous pregnancy carried beyond 20 weeks gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (5)

  • DeLancey JO, Sampselle CM, Punch MR. Kegel dyspareunia: levator ani myalgia caused by overexertion. Obstet Gynecol. 1993 Oct;82(4 Pt 2 Suppl):658-9.

    PMID: 8378003BACKGROUND

  • Sampselle CM, Miller JM, Luecha Y, Fischer K, Rosten L. Provider support of spontaneous pushing during the second stage of labor. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):695-702. doi: 10.1177/0884217505281904.

    PMID: 16282227RESULT

  • Antonakos CL, Miller JM, Sampselle CM. Indices for studying urinary incontinence and levator ani function in primiparous women. J Clin Nurs. 2003 Jul;12(4):554-61. doi: 10.1046/j.1365-2702.2003.00747.x.

    PMID: 12790869RESULT

  • Armstrong SM, Miller JM, Benson K, Jain S, Panagopoulos K, DeLancey JO, Sampselle CM. Revisiting reliability of quantified perineal ultrasound: Bland and Altman analysis of a new protocol for the rectangular coordinate method. Neurourol Urodyn. 2006;25(7):731-8. doi: 10.1002/nau.20299.

    PMID: 16897749RESULT

  • Roberts JM, Gonzalez CBP, Sampselle C. Why do supportive birth attendants become directive of maternal bearing-down efforts in second-stage labor? J Midwifery Womens Health. 2007 Mar-Apr;52(2):134-141. doi: 10.1016/j.jmwh.2006.11.005.

    PMID: 17336819RESULT

MeSH Terms

Conditions

Urinary IncontinencePelvic Organ Prolapse

Interventions

Videotape RecordingData Collection

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProlapsePathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Carolyn M Sampselle, PhD,RNC,FAAN

    University of Michgan School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 25, 2007

Study Start

July 1, 1996

Study Completion

December 1, 2006

Last Updated

July 31, 2007

Record last verified: 2007-05

Locations

US(1)