Labor Pain and Postpartum Behavioral Health Outcomes Study (LPPD)

January 15, 2020 updated by: Grace Lim, MD, MS, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC
      • Pittsburgh, Pennsylvania, United States, 15222
        • The Midwife Center for Birth and Womens Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Edinburgh Postnatal Depression Score (EPDS)
Time Frame: Postpartum Week 6
Postpartum Week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Grace Lim, MD, University of Pittsburgh School of Medicine; Magee-Womens Hospital of UPMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

August 8, 2017

Study Completion (Actual)

September 18, 2017

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO15030338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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