Group Preconception Care for Fertility Patients aims to translate the well-established group prenatal care model to preconception care to improve pregnancy and neonatal outcomes. In partnership with Pomelo Care (a virtual maternity care program), the investigators are conducting this study using couples at Penn Fertility Care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
Groups of 6-10 patients to initiate biweekly virtual group care sessions on a rolling basis, with completion of enrollment and the virtual curriculum within a year.
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
Philadelphia, Pennsylvania, United States
Blood pressure measurement recorded by clinician in Penn EMR
Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no
Time frame: From enrollment to 16 weeks
Weight measurement recorded by clinician in Penn EMR
Was a weight measurement recorded by a clinician in Penn EMR, yes/no
Time frame: From enrollment to 16 weeks
Hemoglobin A1c testing results recorded in Penn EMR
Was a hemoglobin A1c test performed if medically indicated (history of diabetes, BMI\>30) or felt necessary by health care provider, yes/no
Time frame: From enrollment to 16 weeks
Change in Anxiety screening score
Generalized Anxiety Disorder 7 (GAD-7) Questionnaire will be administered to both groups at enrollment, 4 months, and 12 months. The total score for the seven items ranges from 0 to 21, with 21 indicating a worse outcome
Time frame: Enrollment, 4 months, 12 months
Change in Depression screening score
Patient Health Questionnaire 9 (PHQ-9) will be administered to both groups at enrollment, 4 months, and 12 months. The total score for the nine items ranges from 0 to 27 where a high score indicates a worse outcome
Time frame: Enrollment, 4 months, 12 months
Change in Fertility-related quality of life questionnaire score
Fertility Related Quality of Life (FertiQOL) Questionnaire will be administered to both groups at enrollment, 4 months, and 12 months. The 36 FertiQoL items are rated according to 5 types of response scales. The total score is 100, with higher scores indicating worse fertility-related quality of life.
Time frame: Enrollment, 4 months, 12 months
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Incidence of ovulation stimulations
Count of ovarian stimulation treatments
Time frame: From enrollment to 12 months
Incidence of intrauterine inseminations
Count of intrauterine insemination treatments
Time frame: From enrollment to 12 months
Incidence of in vitro fertilizations
Count of in vitro fertilization treatments
Time frame: From enrollment to 12 months
Pregnancy rate
This includes the number of patients who become pregnant during the study period in both groups.
Time frame: From enrollment to 12 months
Time to pregnancy in days
This includes the time until patients become pregnant during the study period in both groups.
Time frame: From enrollment to 12 months
Patient experience
In the intervention arm only, brief questionnaires will be distributed after each virtual session to ask participants to rate their satisfaction with the session. Patients will also complete a cumulative evaluation at the conclusion of the sessions. These surveys will use a Likert scale with a higher score indicating a better experience.
Time frame: Enrollment to 16 weeks
Miscarriage rate
Total number of miscarriages per participants who become pregnant in either group
Time frame: From enrollment up to 18 months
Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy
This will be scored yes if any of the following are noted in the medical record: gestational hypertension (blood pressure \>140/90 on 2 or more occasions at least 4 hours apart), severe preeclampsia (blood pressure \>160/110 on 2 or more occasions at least 4 hours apart, or mildly elevated blood pressures with persistent headache, scotomata, platelet count \<100,000/uL, liver function tests twice the upper limit of normal, or creatinine \>1.1 mg/dL), HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia (elevated blood pressure with seizures).
Time frame: Conception to delivery, approximately 9 months
Number of pregnant participants with a diagnosis of gestational diabetes
This will be scored yes if gestational diabletes is diagnosed. Gestational diabetes is diagnosed based on an abnormal 3-hour glucose tolerance test (1-hour test blood glucose \>135mg/dL will be followed by a 3-hour test). Two or more abnormal values on the 3-hour test is diagnostic of gestational diabetes. Cutoffs are 95 fasting, 180 at 1 hour, 155 at 2 hours, and 140 at 3 hours.
Time frame: Conception to delivery, approximately 9 months
Number of pregnant participants with occurrences with an antepartum hospitalizations
This includes hospital admissions during the pregnancy for any pregnancy or non-pregnancy related complications.
Time frame: Conception to delivery, approximately 9 months
Number of pregnant participants with preterm birth
Preterm delivery is defined as delivery at less than 37 weeks gestational age.
Time frame: At time of delivery
Number of pregnant participants with a cesarean delivery
In participants who become pregnant, the incidence of cesarean delivery
Time frame: At time of delivery
Number of pregnant participants with a NICU admission
Infant admission to neonatal intensive care unit.
Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants
Total number of any presentation to the Perinatal Evaluation Center or emergency room during pregnancy
Time frame: From date of conception to delivery date, approximately 9 months
Among those patients that become pregnant, delivery length of stay
Length of stay from birth to discharge, measured in hours
Time frame: From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery
Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale
Edinburgh Postnatal Depression Scale will either be abstracted from the medical record, or if not administered clinically, will be administered by the study team. The total score for the ten items ranges from 0 to 30 with a higher score indicating a worse outcome.
Time frame: Between 2 to 6 weeks after delivery