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临床试验/NCT05924464
NCT05924464进行中(未招募)不适用

Group Preconception Care for Fertility Patients

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年7月19日最近更新:
适应症
干预措施

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

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

Experimental

Group preconception care

干预措施: Group Preconception Care (Other)

Control arm

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anuja Dokras

Director of the Penn PCOS Center

University of Pennsylvania

研究点 (2)

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