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.
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
- Conditions the study is for
- Postpartum Pelvic Floor Function and Symptoms
- 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
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 group | Role | What they receive |
|---|---|---|
| Nulliparous Women in Third Trimester | Other | Study Procedures Receives: Other: Study Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
Urinary Incontinence Severity
Urinary incontinence severity at 1 year, assessed using the Incontinence Severity Index
Measured: 1 Year
Overactive Bladder Symptoms
Symptom of overactive bladder at 1 year, assessed using the Epidemiology of Prolapse and Incontinence Questionnaire
Measured: 1 Year
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.
- First posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2019
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Pelvic Floor Function and SymptomsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ingrid Nygaard, University of Utah
- Investigators
- Ingrid Nygaard, MD, Study director, University of UtahMarlen Egger, PhD, Principal investigator, University of Utah
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging Physical and Cultural Determinants of Postpartum Pelvic Floor Support and Symptoms Following Vaginal Delivery
- ClinicalTrials.gov ID
- NCT02512016
- Acronym / sponsor ID
- 82389
- Keywords
- Pelvic floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nulliparous Women in Third Trimester | Other | Other: Study ProceduresStudy Procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Estimated gestational age 28 weeks to 36 6/7 weeks
- Nulliparous
- Single gestation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Procedures* 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. | Other | Nulliparous Women in Third Trimester |
Primary outcome
Pelvic Floor Support
Time frame: 1 Year postpartum
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)
Pelvic Floor symptoms
Time frame: 1 Year postpartum
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
4 secondary outcomes
Symptoms of Stress Urinary Incontinence
Time frame: 1 Year
Urinary Incontinence Severity
Time frame: 1 Year
Overactive Bladder Symptoms
Time frame: 1 Year
Constipation Symptoms
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 38314118Ryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Nygaard, MD study director
University of Utah
Marlen Egger, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
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.