Group Preconception Care for Fertility Patients

Primary outcomes

1. Blood pressure measurement recorded by clinician in Penn EMR

   Time frame: From enrollment to 16 weeks

   Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no

2. Weight measurement recorded by clinician in Penn EMR

   Time frame: From enrollment to 16 weeks

   Was a weight measurement recorded by a clinician in Penn EMR, yes/no

3. Hemoglobin A1c testing results recorded in Penn EMR

   Time frame: From enrollment to 16 weeks

   Was a hemoglobin A1c test performed if medically indicated (history of diabetes, BMI>30) or felt necessary by health care provider, yes/no

4. Change in Anxiety screening score

   Time frame: Enrollment, 4 months, 12 months

   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

5. Change in Depression screening score

   Time frame: Enrollment, 4 months, 12 months

   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

6. Change in Fertility-related quality of life questionnaire score

   Time frame: Enrollment, 4 months, 12 months

   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.

7. Incidence of ovulation stimulations

   Time frame: From enrollment to 12 months

   Count of ovarian stimulation treatments

8. Incidence of intrauterine inseminations

   Time frame: From enrollment to 12 months

   Count of intrauterine insemination treatments

9. Incidence of in vitro fertilizations

   Time frame: From enrollment to 12 months

   Count of in vitro fertilization treatments

10. Pregnancy rate

    Time frame: From enrollment to 12 months

    This includes the number of patients who become pregnant during the study period in both groups.

11. Time to pregnancy in days

    Time frame: From enrollment to 12 months

    This includes the time until patients become pregnant during the study period in both groups.

12. Patient experience

    Time frame: Enrollment to 16 weeks

    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.

13. Miscarriage rate

    Time frame: From enrollment up to 18 months

    Total number of miscarriages per participants who become pregnant in either group

14. Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy

    Time frame: Conception to delivery, approximately 9 months

    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).

15. Number of pregnant participants with a diagnosis of gestational diabetes

    Time frame: Conception to delivery, approximately 9 months

    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.

16. Number of pregnant participants with occurrences with an antepartum hospitalizations

    Time frame: Conception to delivery, approximately 9 months

    This includes hospital admissions during the pregnancy for any pregnancy or non-pregnancy related complications.

17. Number of pregnant participants with preterm birth

    Time frame: At time of delivery

    Preterm delivery is defined as delivery at less than 37 weeks gestational age.

18. Number of pregnant participants with a cesarean delivery

    Time frame: At time of delivery

    In participants who become pregnant, the incidence of cesarean delivery

19. Number of pregnant participants with a NICU admission

    Time frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

    Infant admission to neonatal intensive care unit.

20. Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants

    Time frame: From date of conception to delivery date, approximately 9 months

    Total number of any presentation to the Perinatal Evaluation Center or emergency room during pregnancy

21. Among those patients that become pregnant, delivery length of stay

    Time frame: From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery

    Length of stay from birth to discharge, measured in hours

22. Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale

    Time frame: Between 2 to 6 weeks after delivery

    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.