AzTrials
AzTrials

Postpartum Pelvic Floor Function and SymptomsNCT02512016

Motherhood and Pelvic Health (MAP Study)

A study testing Study Procedures in people with Postpartum Pelvic Floor Function and Symptoms, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Study Procedures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,079 participants
Where
1 siteUnited States
Study dates
Aug 2015to 15 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah Hospital

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Bridging Physical and Cultural Determinants of Postpartum Pelvic Floor Support and Symptoms Following Vaginal Delivery

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.

Read the detailed description

Vaginal delivery affects pelvic muscles, nerves and connective tissue. Despite the similarities between vaginal delivery and other non-pelvic soft tissue injuries, research to date has not focused on factors related to recovery from childbirth, but instead has been directed at intrapartum interventions. A woman's pelvic floor derives its ability to withstand loads from physical activities due to her inherent genetic make-up that sets the foundation for her muscle, connective tissue, bone and other structures, her history of injury, and her ability to recover from injuries. Over the past decade, investigators have gained important information about some of the ways in which vaginal delivery affects the structure and function of the pelvic floor.

However, investigators know very little about how pelvic floor function recovers after vaginal delivery. This study will look at whether the non-pregnant milieu, including physical and cultural factors, mediate the effects of vaginal childbirth. Study investigators propose that pelvic floor support and symptoms 1 year after the first vaginal delivery are affected by biologically plausible factors that may impact muscle, nerve and connective tissue healing during the postpartum recovery period (first 8 weeks postpartum) and pelvic floor function during the postpartum strengthening period (remainder of the first postpartum year): in particular, timing and dose of moderate/vigorous physical activity and inactivity, and timing of and exposure to a range of intra-abdominal pressures. Our investigators further propose that perception of pelvic floor support and symptoms 1 year after vaginal delivery are influenced by cultural attributes and beliefs. Finding relationships between physical activity, muscular strength, intra-abdominal pressure and pelvic floor support /symptoms will provide realistic targets for disease prevention and pelvic floor health management.

Hispanics are the fastest-growing ethnic group in the United States. Although the risks for pelvic floor disorders differ among ethnic and racial groups, few studies have examined these differences. There is a critical need for research among Hispanic women. In this Program, our investigators will study personal and cultural aspects of Mexican-American and Euro-American primiparas' experiences of the earliest changes that happen after childbirth and make them understandable to women and clinicians, creating an opportunity for dialogue across lay and medical discourses.

The aims of each project are summarized below.

PROJECT 1 Intra-abdominal pressure and postpartum pelvic floor support and symptoms

By using an intra-vaginal sensor to measure intra-abdominal pressure in primiparous women, investigators will:

Aim 1: Determine whether IAP measured at 8 weeks postpartum during a) lifting and b) abdominal muscle endurance testing predicts pelvic floor support and symptoms 1 year postpartum.

Aim 2: Determine whether measures of muscular fitness modify the effect of IAP during lifting on pelvic floor support at 1 year postpartum.

PROJECT 2: Physical activity, inactivity, and fitness: Impact on postpartum pelvic floor support and symptoms

Aims: To determine, in primiparous women after vaginal delivery, whether physical activity, sedentary time and the characteristics of body habitus and muscular fitness are associated with 1) pelvic floor support and 2) pelvic floor symptoms 1 year postpartum.

PROJECT 3: The cultural context of postpartum pelvic floor support following vaginal delivery: a comparative ethnographic analysis of Mexican-American and Euro-American women.

Aim: To describe primiparous Mexican-American and Euro-American women's experiences and cultural knowledge of postpartum pelvic floor support changes.

Sub-aim 1: To characterize the ways women perceive and make sense of early changes in pelvic floor support as well as the ways they use language and discourse to construct meaning about those changes in the year after their first delivery.

Aim 1.2: To describe how primipara share experiences and cultural understandings of postpartum pelvic floor support with mothers, partners, sisters, and confidantes in their families and social networks.

Sub-aim 1: To explore the interplay of women's understandings of early changes in pelvic floor support with sociocultural prescriptions/proscriptions regarding physical activity and any resulting postpartum alterations of activity which they may undertake.

Estimated enrollment: 1530 women in third trimester to obtain final enrollment goal of 585 women at 1 year postpartum. (We estimate that, after initial enrollment, we will exclude 26.5% that deliver by cesarean, 10% that deliver before 37 weeks, and that 20% will withdraw between delivery and 8 weeks postpartum, 20% will withdraw between 8 weeks and 1 year postpartum, and 6% will have known pregnancy by 1 year postpartum, leaving 585 with final 1-year data.)

Being tested
Study Procedures
Keywords
Pelvic floor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.
Study groups in NCT02512016
Study groupRoleWhat they receive
Nulliparous Women in Third TrimesterOtherStudy Procedures
Receives: Other: Study Procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 Year postpartum

  2. 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

    Measured: 1 Year postpartum

Secondary outcomes (4)
  1. Symptoms of Stress Urinary Incontinence

    Symptom of stress urinary incontinence at 1 year, assessed using the Epidemiology of Prolapse and Incontinence Questionnaire

    Measured: 1 Year

  2. Urinary Incontinence Severity

    Urinary incontinence severity at 1 year, assessed using the Incontinence Severity Index

    Measured: 1 Year

  3. Overactive Bladder Symptoms

    Symptom of overactive bladder at 1 year, assessed using the Epidemiology of Prolapse and Incontinence Questionnaire

    Measured: 1 Year

  4. Constipation Symptoms

    Constipation at 1 year, assessed using the Defecation Distress Inventory

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJan 2019
  4. Study completion15 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,079 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02512016
Sponsor's protocol ID
82389
Status last verified
Jul 2021
First submitted
16 Jul 2015
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38314118

Questions about this trial

What is this clinical trial studying?

A study testing Study Procedures in people with Postpartum Pelvic Floor Function and Symptoms, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pelvic Floor Support (time frame: 1 Year postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02512016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in