NCT02512016

Brief Summary

The Motherhood and Pelvic health study (MAP), Bridging physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery, uses mixed methods research to study the influences of intra-abdominal pressure, physical activity and strength on pelvic floor support and symptoms and the cultural context in which women experience those changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,079

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 16, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

3.4 years

First QC Date

July 16, 2015

Last Update Submit

July 29, 2021

Conditions

Postpartum Pelvic Floor Function and Symptoms

Keywords

Pelvic floor

Outcome Measures

Primary Outcomes (2)

  • Pelvic Floor Support

    Assessed using the Pelvic Organ Prolapse Quantification examination, categorized into maximum vaginal descent at or below the hymen (\>/= 0 cm) versus above the hymen (\< 0 cm)

    1 Year postpartum

  • Pelvic Floor symptoms

    Assessed using the Epidemiology of Prolapse and Incontinence Questionnaire, dichotomized as the presence of symptoms accompanied by at least minimal bother (\>0 on the visual analogue scale) in at least 2 (vs 0 or 1) of the 6 domains

    1 Year postpartum

Secondary Outcomes (4)

  • Symptoms of Stress Urinary Incontinence

    1 Year

  • Urinary Incontinence Severity

    1 Year

  • Overactive Bladder Symptoms

    1 Year

  • Constipation Symptoms

    1 Year

Study Arms (1)

Nulliparous Women in Third Trimester

OTHER

Study Procedures

Other: Study Procedures

Interventions

Study ProceduresOTHER

* Pelvic Organ Prolapse Quantification exam (3rd tri, 8 wks and 1 yr postpartum) * Intra-abdominal pressure measure. At 8 weeks: IAP during lifting 12.5 kg and abdominal muscle endurance testing. At 1 year: IAP during lifting 17.5 kg and abdominal muscle endurance testing. * Accelerometry: Wrist accelerometer (objective quantification of physical activity) x 1 wk 2-3 and 5-6 wks and 6 mo postpartum. * Measures of strength and body habitus: 8 weeks and 1 year postpartum: Abdominal muscle endurance Abdominal adiposity Body mass index 1 year postpartum: Pelvic floor muscle strength: tested using a Peritron manometer Body composition: using air displacement plethysmography using the BodPod * Qualitative interviews: A smaller number of participants will be purposefully selected for the qualitative interviews in order to understand examples of the postpartum sensations and experiences of women with a wide variety of characteristics and from various social and cultural settings.

Nulliparous Women in Third Trimester

Eligibility Criteria

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

You may qualify if:

  • years and older
  • Estimated gestational age 28 weeks to 36 6/7 weeks
  • Nulliparous
  • Single gestation

You may not qualify if:

  • Obstructive pulmonary disease
  • Collagen disorder such as Marfan's or Ehlers-Danlos
  • Muscular dystrophy
  • Prior surgical procedure for urinary incontinence or pelvic organ prolapse
  • Required ambulatory aid before pregnancy
  • No access to telephone or computer during course of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Ryan JT, Day H, Egger MJ, Wu J, Depner CM, Shaw JM. Night-time sleep duration and postpartum weight retention in primiparous women. Sleep Adv. 2023 Dec 27;5(1):zpad056. doi: 10.1093/sleepadvances/zpad056. eCollection 2024.

    PMID: 38314118DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ingrid Nygaard, MD

    University of Utah

    STUDY DIRECTOR

  • Marlen Egger, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 30, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2019

Study Completion

August 15, 2020

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

US(1)