This is a prospective cohort study, with a pre–post design. The control group was recruited first (August 2022 to June 2023) and received standard postpartum care. The intervention group was recruited second (July 2023 to February 2024) and received standard postpartum care plus an additional telehealth consultation with a urogynecologist at 8–12 weeks postpartum. The pre–post design was chosen to prevent cross-over or contamination between participant groups as there is significant communication between patients in the obstetric community in our region (particularly through social media groups for new parents and/or for people who have experienced certain peripartum complications). Telehealth visits are not standard practice for postpartum care in our region.
Study PopulationParticipants in the study met the following inclusion criteria: 18 years or older, English or French speaking, vaginal delivery, singleton birth, delivery at 36 weeks gestational age or later, third- or fourth-degree perineal laceration associated with delivery. Participants were recruited via referral from a member of the patient’s healthcare team. Deliveries occurred at our tertiary care centre with approximately 6800 deliveries per year by obstetricians, family medicine physicians and midwives at two hospital sites. Standard practice is for patients delivering under midwifery or family medicine physician care to be referred to an obstetrician for immediate repair of severe perineal lacerations (including OASI).
InterventionParticipants in the control group received standard postpartum care, with the scheduling and number of visits determined by each patient’s care provider (obstetrician, family physician, or midwife). For most patients this would be a follow-up visit approximately 6-weeks postpartum, with further investigations, interventions, or referrals made at the discretion of their care provider.
Participants in the intervention group received standard postpartum care, as well as an additional urogynecology telehealth phone consultation at 8–12 weeks postpartum. This telehealth consultation focused on pelvic floor symptoms and resumption of routine activities, addressing pelvic health concerns, and (if relevant) discussing future pregnancy planning. These telehealth consultations were conducted by either a urogynecologist or urogynecology fellow. The timing of this visit was chosen to occur after the standard 6-week postpartum follow-up, to assess the need for additional resources or follow-up after completion of standard postpartum care. Participants were referred for in-person assessment, investigations, and/or treatment as needed.
Data CollectionDemographic data was collected during referral from a member of the participant’s healthcare team. Participants in both cohorts completed an anonymous online survey at 16-weeks postpartum, via a link sent to their email address, which included the validated questionnaires listed below. See Supplemental Information 1 for the survey questionnaires. Participants in the telehealth cohort had data regarding their consultation recorded by the telehealth provider.
Outcome MeasuresThe primary outcome was Pelvic Floor Distress Inventory (PFDI-20) cumulative score at 16-weeks postpartum [18]. Secondary outcomes included the following: individual scores for the three domains within the PFDI-20—Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8), and Urinary Distress Inventory (UDI-6); Patient Enablement Instrument (PEI) a validated questionnaire assessing a patient’s ability to understand and cope with illness and life after a medical consultation [19, 20]; QQ10 a questionnaire developed to measure the value and burden of patient experience [21], which has been modified and used to evaluate patient experience of telehealth consultations [22]; and the proportion of patients requiring additional follow-up, including investigations, interventions, or referrals.
We collected information on relevant covariates, including age, maternal pre-pregnancy body mass index (BMI), birthweight of baby, type of vaginal birth (spontaneous, vacuum-assisted, forceps-assisted), number of vaginal deliveries, number of caesarean deliveries, pelvic health concerns prior to most recent delivery, and presence of private health insurance. Perineal lacerations were classified as either partial third-degree (3A or 3B), complete third-degree (3C), or fourth-degree.
Statistical AnalysesTo detect a 10-point reduction in PFDI-20 score (previously determined to be clinically significant) [23], assuming an average baseline score of 40 out of 100 and an estimated standard deviation of 20 (based on previous data [24]), we aimed to recruit a sample size of 128 participates (64 per group), providing a power of 0.8.
We performed t-tests for continuous variables and chi-squared tests for categorical variables to evaluate for differences in baseline patient characteristics between control and intervention groups and to evaluate study outcomes. A subset analysis was completed for patients with severe OASI (3C or fourth-degree tears) given the known higher rates of pelvic floor dysfunction among these patients. As part of this subset analysis, a multivariable linear regression model was completed to evaluate for differences in PFDI-20 score between the cohorts, adjusting for age, BMI, and number of vaginal births.
The POPDI-6, CRADI-8, and UDI-6 scores were calculated by obtaining the mean value of all the items within the corresponding scale and multiplying by 25 (range 0 to 100). The PFDI-20 summary score was calculated by adding the three component scales together (range 0 to 300). Missing data in the PFDI-20 (0.2% of responses missing) were replaced with the mean of the responses in the same category, per PFDI-20 described scoring protocol. PEI scores were calculated by assigning a score of 0–2 for each of the six items (total score range 0 to 12), with higher scores representing greater patient enablement. For the PEI, one participant in the control group did not answer this section of the survey, only complete responses were used for comparison. The QQ10 value and burden scores were calculated by adding the scores of the six “value” items and the four “burden” items, followed by transformation of the scores onto a scale of 0–100, with 100 representing the best possible value score, and 0 representing the best possible burden score [21, 22].
Data analyses were completed using STATA, version 15.1.
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