Group Preconception Care for Fertility Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Blood pressure measurement recorded by clinician in Penn EMR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention arm
Group preconception care
干预措施: Group Preconception Care (Other)
Control arm
Usual care (completion of questionnaires only)
结局指标
主要结局
Blood pressure measurement recorded by clinician in Penn EMR
时间窗: From enrollment to 16 weeks
Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no
Weight measurement recorded by clinician in Penn EMR
时间窗: From enrollment to 16 weeks
Was a weight measurement recorded by a clinician in Penn EMR, yes/no
Incidence of intrauterine inseminations
时间窗: From enrollment to 12 months
Count of intrauterine insemination treatments
Hemoglobin A1c testing results recorded in Penn EMR
时间窗: 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
Change in Anxiety screening score
时间窗: 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
Pregnancy rate
时间窗: From enrollment to 12 months
This includes the number of patients who become pregnant during the study period in both groups.
Time to pregnancy in days
时间窗: From enrollment to 12 months
This includes the time until patients become pregnant during the study period in both groups.
Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy
时间窗: 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).
Number of pregnant participants with a diagnosis of gestational diabetes
时间窗: 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.
Change in Fertility-related quality of life questionnaire score
时间窗: 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.
Change in Depression screening score
时间窗: 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
Incidence of in vitro fertilizations
时间窗: From enrollment to 12 months
Count of in vitro fertilization treatments
Patient experience
时间窗: 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.
Number of pregnant participants with preterm birth
时间窗: At time of delivery
Preterm delivery is defined as delivery at less than 37 weeks gestational age.
Number of pregnant participants with a cesarean delivery
时间窗: At time of delivery
In participants who become pregnant, the incidence of cesarean delivery
Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants
时间窗: 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
Incidence of ovulation stimulations
时间窗: From enrollment to 12 months
Count of ovarian stimulation treatments
Number of pregnant participants with occurrences with an antepartum hospitalizations
时间窗: Conception to delivery, approximately 9 months
This includes hospital admissions during the pregnancy for any pregnancy or non-pregnancy related complications.
Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale
时间窗: 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.
Miscarriage rate
时间窗: From enrollment up to 18 months
Total number of miscarriages per participants who become pregnant in either group
Number of pregnant participants with a NICU admission
时间窗: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Infant admission to neonatal intensive care unit.
Among those patients that become pregnant, delivery length of stay
时间窗: 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
次要结局
未报告次要终点
研究者
Anuja Dokras
Director of the Penn PCOS Center
University of Pennsylvania
