This will be a prospective, randomized clinical trial of postpartum breastfeeding
patients. Postpartum patients at University Hospitals (UH) MacDonald Women's Hospital
will be evaluated for inclusion/exclusion by review of their medical record by the study
investigators prior to discharge home. The study will then be discussed with the eligible
patients privately. If they agree to participate, informed consent will be obtained. At
this time, contact information will be obtained for all consenting patients.
Between 5 and 6 weeks postpartum, all consented patients will be contacted via their
preferred form of communication. Inclusion criteria and desire for continued study
participation will be verified prior to randomization. A baseline REDCap questionnaire
will be texted or emailed to confirmed study participants. UH REDCap is a
HIPAA-certified, secure, web-based data storage platform for research studies.
The patient will then be randomized in a 1:1 ratio into two study groups: vaginal
estrogen or vaginal moisturizer. Randomization will be performed using blocking with a
block size of 10 and a 1:1 allocation ratio. The randomization sequence will be generated
using a random number table.
After randomization, but not prior to 6 weeks postpartum, the investigational drug
service courier service will deliver softgel inserts of vaginal estrogen to the homes of
participants randomized to the estrogen arm. Study investigators will deliver vaginal
moisturizer to the homes of participants randomized to the placebo arm. Study
participants will be provided with an instructional handout including information about
how and how often to use the inserts or the moisturizer. Participants will be instructed
to start using the inserts or lubricant when they receive the delivery. This will be
considered the start of the study period.
During the study period, participants will use either estrogen or vaginal moisturizer
nightly for two weeks and then twice weekly for ten weeks. Each week during the study
period, participants will receive a message via their preferred communication method with
five questions:
Did you breastfeed or pump this week?
Were you sexually active this week?
If you were sexually active, did you have vaginal pain with sexual activity?
How many times this week did you use the vaginal insert?
Did you experience any change in your health this week?
6 and 12 weeks into the study period, the patient will be contacted by their
preferred communication method and requested to complete a questionnaire via UH
REDCap.
The initial study questionnaire will include questions about demographics, gravidity and
parity, prior deliveries (including mode of delivery, obstetric lacerations, and infant
feeding), baseline sexual activity, prior pelvic surgery, chronic pain disorders, and
plans for infant feeding. The 6 and 12-week study questionnaires will include the FSFI,
the GAD-7 anxiety questionnaire, the Edinburgh Postnatal Depression Scale (EPDS), and the
urinary distress inventory (UDI-6), the vaginal assessment scale (VAS), the Sexual
Function Questionnaire Medical Impact Scale (SFQ-MIS), and the Female Sexual Distress
Scale-Revised (FSDS-R) as well as questions about sexual activity and plans for infant
feeding.
Questionnaire responses will be reviewed by a study investigator after completion by the
patient. Any patients whose questionnaires indicate possible depression (EPDS score 10+),
thoughts of self-harm (any answer other than "never" on EPDS question 10), or moderate to
severe anxiety (GAD-7 score 10+) will be evaluated for safety by a physician study
investigator and referred to UH Reproductive Behavioral Health.
In order to assess long term benefits of estrogen therapy in the early postpartum period,
additional questionnaires will be administered at 6 months and 1 year to patients. The
study intervention period will last 12 weeks, after which no additional vaginal estrogen
or vaginal moisturizer will be administered to participants. Patients desiring to
continue treatment after the 12-week study intervention period will be referred to their
postpartum care provider. Patients will be instructed to stop estrogen use after they
have completed breastfeeding.