Clinical trial NCT05924464: Group Preconception Care for Fertility Patients
Official title: Group Preconception Care for Fertility Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Pomelo Care, Inc.
name: Independence Blue Cross
First posted: 2023-06-29
Enrollment: 140
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Female new patient seen at Penn Fertility Care for infertility or procreative management
2. Currently planning to conceive
3. Intending to carry pregnancy (i.e. will not need a gestational carrier), since our project aims to implement lifestyle changes prior to conception
4. Willing to be randomized to group preconception care versus usual care

Exclusion Criteria:

1. 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
2. Known need for gestational carrier, as above
3. Planning preimplantation genetic testing for monogenic disorders or egg/embryo banking
4. Non-English speaking
5. Unable to complete electronic questionnaires due to lack of access to technology

Primary outcomes:
measure: Blood pressure measurement recorded by clinician in Penn EMR
timeFrame: From enrollment to 16 weeks
measure: Weight measurement recorded by clinician in Penn EMR
timeFrame: From enrollment to 16 weeks
measure: Hemoglobin A1c testing results recorded in Penn EMR
timeFrame: From enrollment to 16 weeks
measure: Change in Anxiety screening score
timeFrame: Enrollment, 4 months, 12 months
measure: Change in Depression screening score
timeFrame: Enrollment, 4 months, 12 months
measure: Change in Fertility-related quality of life questionnaire score
timeFrame: Enrollment, 4 months, 12 months
measure: Incidence of ovulation stimulations
timeFrame: From enrollment to 12 months
measure: Incidence of intrauterine inseminations
timeFrame: From enrollment to 12 months
measure: Incidence of in vitro fertilizations
timeFrame: From enrollment to 12 months
measure: Pregnancy rate
timeFrame: From enrollment to 12 months
measure: Time to pregnancy in days
timeFrame: From enrollment to 12 months
measure: Patient experience
timeFrame: Enrollment to 16 weeks
measure: Miscarriage rate
timeFrame: From enrollment up to 18 months
measure: Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy
timeFrame: Conception to delivery, approximately 9 months
measure: Number of pregnant participants with a diagnosis of gestational diabetes
timeFrame: Conception to delivery, approximately 9 months
measure: Number of pregnant participants with occurrences with an antepartum hospitalizations
timeFrame: Conception to delivery, approximately 9 months
measure: Number of pregnant participants with preterm birth
timeFrame: At time of delivery
measure: Number of pregnant participants with a cesarean delivery
timeFrame: At time of delivery
measure: Number of pregnant participants with a NICU admission
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
measure: Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants
timeFrame: From date of conception to delivery date, approximately 9 months
measure: Among those patients that become pregnant, delivery length of stay
timeFrame: From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery
measure: Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale
timeFrame: Between 2 to 6 weeks after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Reproductive Research Unit, 3701 Market Street, Suite 810
state: Pennsylvania
Study officials:
References: