LPPD: Labor Pain and Postpartum Behavioral Health Outcomes Study

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT02692404

Collaborator

(none)

199

Enrollment

Locations

20.6

Duration (Months)

99.5

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

What is the association between perceived intensity and unpleasantness of labor pain and postpartum behavioral health outcomes?
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 Design

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 :

Jan 1, 2016

Actual Primary Completion Date :

Aug 8, 2017

Actual Study Completion Date :

Sep 18, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Edinburgh Postnatal Depression Score (EPDS) [Postpartum Week 6]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213
2	The Midwife Center for Birth and Womens Health	Pittsburgh	Pennsylvania	United States	15222