Group Preconception Care for Fertility Patients

Study Overview
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Brief Summary
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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.

Official Title
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Group Preconception Care for Fertility Patients

Conditions
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Infertility

Intervention / Treatment
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* Other: Group Preconception Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female new patient seen at Penn Fertility Care for infertility or procreative management Currently planning to conceive Intending to carry pregnancy (i.e. will not need a gestational carrier), since our project aims to implement lifestyle changes prior to conception Willing to be randomized to group preconception care versus usual care Exclusion Criteria: Prior infertility treatment at other practice in this initial project, we aim to focus on patients with a new diagnosis of infertility to allow time for completion of the virtual program during the diagnostic phase and early treatment phase Known need for gestational carrier, as above Planning preimplantation genetic testing for monogenic disorders or egg/embryo banking Non-English speaking Unable to complete electronic questionnaires due to lack of access to technology
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Group preconception care | Other: Group Preconception Care<br>* 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.<br>|
| No Intervention: Control arm<br>Usual care (completion of questionnaires only) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure measurement recorded by clinician in Penn EMR | Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no | 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 | 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 | 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 | 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 | 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. | Enrollment, 4 months, 12 months | 
| Incidence of ovulation stimulations | Count of ovarian stimulation treatments | From enrollment to 12 months | 
| Incidence of intrauterine inseminations | Count of intrauterine insemination treatments | From enrollment to 12 months | 
| Incidence of in vitro fertilizations | Count of in vitro fertilization treatments | From enrollment to 12 months | 
| Pregnancy rate | This includes the number of patients who become pregnant during the study period in both groups. | 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. | 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. | Enrollment to 16 weeks | 
| Miscarriage rate | Total number of miscarriages per participants who become pregnant in either group | 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). | 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. | 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. | 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. | At time of delivery | 
| Number of pregnant participants with a cesarean delivery | In participants who become pregnant, the incidence of cesarean delivery | At time of delivery | 
| Number of pregnant participants with a NICU admission | Infant admission to neonatal intensive care unit. | 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 | 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 | 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. | Between 2 to 6 weeks after delivery |