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Labor Pain and Postpartum Behavioral Health Outcomes Study (LPPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02692404
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Grace Lim, MD, MS, University of Pittsburgh

Brief Summary:
In this pilot prospective longitudinal observational study, women who are pregnant and who will be experiencing childbirth for the first time will be recruited at the third trimester and observed longitudinally for psychiatric and pain characteristics until 3 months postpartum. The primary outcome is postpartum depression, assessed by Edinburgh Postnatal Depression Scale (EPDS). Infants will also be observed for infant development characteristics over time. Women who choose to receive labor epidural analgesia will be observed, as well as women who choose to avoid labor epidural analgesia. At baseline, women will complete baseline surveys as well as a baseline pain sensitivity test (quantitative sensory testing, QST). During labor, they will complete an electronic pain diary delivered by a bedside mobile device. Three postpartum assessments will occur over 3 months to assess maternal depression, other psychosocial variables, and infant development.

Condition or disease
Depression, Postpartum Pregnancy Child Development Pain Labor Pain

Detailed Description:

Our primary goal in this prospective observational study is to observe laboring women's sensitivity to, and characteristics of, labor pain, for the primary outcome of postpartum depression. Secondary endpoints include parenting self-efficacy, maternal-infant attachment, and infant development. The purpose of this pilot phase is to establish study protocol feasibility, and secondarily to determine trends that will inform future sample size calculations for a larger prospective study.

Our key research questions are:

  1. What is the association between perceived intensity and unpleasantness of labor pain and postpartum behavioral health outcomes?
  2. Do personality, psychological, and genetic factors associated with depression correlate with differences in labor pain experience?

Our hypothesis is that new mothers who have lower pain intensity and unpleasantness during the labor and delivery period will have a reduced risk for postpartum depression, defined by Edinburgh Postnatal Depression Score (EPDS) score. We secondarily hypothesize that women with lower labor pain intensity and unpleasantness scores will have improved maternal-infant attachment, higher parenting self-efficacy, lower perceived stress, and that their infants will exhibit improved child development.

Methods: Baseline assessments of depression, anxiety, resiliency, perceived social support, pain catastrophising, and quantitative sensory testing (QST) will be undertaken. Baseline saliva samples will be collected for future genetic analysis. Throughout labor, pain will be assessed at high density and frequency by an electronic pain diary (mobile app developed by the study team), delivered at the bedside by a portable electronic device (Android tablet) provided by the study team. Labor variables will be recorded, including number of manual epidural supplemental doses, total dose of local anesthetic delivered, and the outcome of labor. Postpartum assessments will include depression, pain inventory, anxiety, perceived stress, maternal-infant bonding, breastfeeding, child development, and parenting self-efficacy.

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Study Type : Observational
Actual Enrollment : 199 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Labor Pain and Postpartum Behavioral Health Outcomes Study
Study Start Date : January 2016
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : September 18, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Hospital Birth
Healthy nulliparous participants, planning spontaneous vaginal or induced vaginal delivery, and planning delivery at a hospital woman-care birth center (Magee-Womens Hospital of UPMC) will be consented to participate in the study at their 3rd trimester clinic visit. Participants and their newborns will be followed for a period of 3 months postpartum. They will be planning to utilize labor epidural analgesia for pain control during labor.
Midwife Center Birth
Healthy nulliparous participants, planning vaginal delivery under the primary care of a nurse midwife (The Midwife Center for Birth and Womens Health, or UPMC-Mercy) will be consented to participate in the study at their 3rd trimester clinic visit. Participants and their newborns will be followed for a period of 3 months postpartum. They will be planning to avoid labor epidural analgesia for pain control during labor.



Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: Postpartum Week 6 ]

Secondary Outcome Measures :
  1. Perceived Stress [ Time Frame: Postpartum Day 1 or 2 ]
  2. Brief Pain Inventory [ Time Frame: Postpartum Day 1 or 2, 6 weeks, and 3 months ]
  3. Maternal-Infant Attachment [ Time Frame: Postpartum Week 6, and 3 months ]
  4. Parenting Self-Efficacy [ Time Frame: Postpartum Week 6, and 3 months ]
  5. Child Development [ Time Frame: Postpartum Week 6, and 3 months ]
  6. Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
Saliva samples for DNA extraction


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy, nulliparous women, aged ≥18, planning spontaneous or induced labor and delivery at term gestation. Women who have risk factors for depression will be included. Risk factors are defined as history of abuse (partner, sexual, domestic, childhood, and substance); history of mental illness; lack of social support; and depression or anxiety. Women will have been and will continue to receive perinatal care at Magee-Womens Hospital or at The Midwife Center for Birth and Women's Health (TMC). A subset of women who receive care at TMC will choose to deliver at UPMC Mercy and will plan to avoid labor epidural analgesia. All women and their infants will be available for followup at 3 months.
Criteria

Inclusion Criteria:

  • Nulliparous
  • Aged ≥18
  • Proficiency in English language
  • Planning spontaneous or induced labor and delivery
  • Planning to avoid labor epidural analgesia (Midwife Center group)
  • Planning to utilize labor epidural analgesia (Magee-Womens Hospital group)
  • Receiving perinatal care at Magee-Womens Hospital or at The Midwife Center for Birth and Women's Health
  • Available and committed for followup at 3 months

Exclusion Criteria:

  • Severe maternal obstetric disease
  • Known or suspected severe fetal comorbid disease
  • Contraindications to neuraxial anesthesia
  • Unable to follow study protocol over 3 months
  • Plans for newborn adoption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692404


Locations
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United States, Pennsylvania
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
The Midwife Center for Birth and Womens Health
Pittsburgh, Pennsylvania, United States, 15222
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Grace Lim, MD University of Pittsburgh School of Medicine; Magee-Womens Hospital of UPMC
Publications:

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Responsible Party: Grace Lim, MD, MS, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02692404    
Other Study ID Numbers: PRO15030338
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Grace Lim, MD, MS, University of Pittsburgh:
Postpartum Depression
Perinatal Depression
Pregnancy
Anesthesia
Obstetric
Pain
Analgesia
Epidural
Midwife
Infant Development
Pain Management
Additional relevant MeSH terms:
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Depression, Postpartum
Labor Pain
Depression
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Puerperal Disorders
Pregnancy Complications