Clinical trial NCT06702475: Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia at Altitude?
Official title: Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pre-Eclampsia
Keywords: Pre-Eclampsia, Altitude, Sleep Apnea
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2024-11-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women, age 15-35, some who are healthy, and some who have developed preeclampsia.

Brief summary: Women at altitude have an increased incidence of pre-eclampsia. Populations at altitude have a greater incidence of sleep apnea. And women with sleep apnea are at increased risk of developing preeclampsia. This research project will recruit for home sleep testing: healthy pregnant women at altitude (Summit County , Colorado at 9000 ft.), and women with preeclampsia at altitude, in order to learn whether either sleep apnea or nocturnal hypoxemia is more common or more severe in women with preeclampsia, than in healthy women at altitude. In addition a healthy co-hort of pregnant women will be studied at sea level, to compare to the healthy cohort of pregnant woman in Summit County, to learn to degree that this difference in altitude effects the severity of sleep apnea and hypoxemia.

Detailed description: It is known that high altitude increases the risk of preeclampsia and small for gestational age births. Our questions are: 1). Is sleep apnea during pregnancy more common and/or more severe at altitude? And 2) Do the women who develop preeclampsia at altitude have more severe sleep apnea, or worse hypoxemia during sleep, than the women at altitude who do not develop preeclampsia. We will perform WatchPAT-one home sleep tests (PAT = peripheral arterial tonometry) on up to 20 pregnant women in Summit County Colorado (\>9000 ft.elevation) who develop preeclampsia during pregnancy (soon after diagnosis), and also on up to 20 pregnant healthy women in Summit County, and 20 healthy pregnant women in Baltimore (at sea level). These healthy pregnant women in Summit County and Baltimore will be selected from volunteer participants, to best match age, pre-pregnancy BMI, and race with individuals in Summit County who are studied with preeclampsia and they will be studied at the gestational timing that matches their Summit County preeclampsia matching subject. In addition to the up to 20 healthy pregnant subjects at Summit County and 20 in Baltimore, who match the preeclampsia subjects, we will recruit up to 20 more in Summit County and 20 more in Baltimore, to study specifically in the 33rd or 34th gestational week, to improve our ability to evaluate the effects of altitude on sleep apnea, during pregnancy. Information on the births, including height and weight and apgar scores will be assessed, in part to see whether sleep apnea during pregnancy affects outcomes. All sleep studies will be scored at the JHH (Johns Hopkins Hospital) Bayview sleep lab's Center for Interdisciplinary Sleep Research and Education.

Eligibility criteria: Inclusion Criteria: pregnant, age 18-35, possession of, or availablitiy of using a cell phone.

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Exclusion Criteria: for the control group the following are exclusion criteria: hypertension, known sleep apnea, asthma requiring daily inhaler use, other lung disease, diabetes

For the group who are recruited at the time of diagnosis of pre-eclampsia - hypertension is not an exclusion criteria.

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Primary outcomes:
measure: Apnea-Hypopnea index 4%
timeFrame: in a single full night recording
Secondary outcomes:
Other outcomes:
measure: Apnea-Hypopnea Index 3%
timeFrame: in a single full night recording
measure: Central Apnea-Hypopnea Index 4%
timeFrame: in a single full night recording
measure: Central Apnea Hypopnea Index 3%
timeFrame: in a single full night recording
measure: Mean Oxygen Saturation during sleep
timeFrame: averaged through one full night recording
measure: Lowest oxygen saturation during sleep
timeFrame: during one full night recording
measure: Time (in minutes) with oxygen saturation below 89%
timeFrame: during one full night recording
measure: Time (in minutes) with oxygen saturation below 85%
timeFrame: during one full night recording
measure: percentage of babies small for gestational age
timeFrame: measurements made at birth. Correlations will be determined at completion of research study
measure: Apgar at 1 minute
timeFrame: Measurement, 1 minute after birth. Correlations will be determined at completion of research study.
measure: Apgar at 5 minutes
timeFrame: Measurement, 5 minutes after birth. Correlations will be determined at completion of research study
Locations:
Study officials:
affiliation: Johns Hopkins Hospital OB-GYN
name: Cynthia Argani, MD
role: STUDY_CHAIR
References: