Fetal Outcome of Sleep Disordered Breathing During Pregnancy
Sponsor: Israel Science Foundation
A observational or N/A phase clinical study on Pregnant Women, this trial is ongoing. The trial is conducted by Israel Science Foundation and has accumulated 6 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Sleep questionnaire: The questionnaire is based on validated questionnaires and includes information on snoring, sleep pauses and daytime sleepiness.Completed questionnaires will be reviewed weekly, and women with either severe daytime sleepiness or self reported frequent snoring or any degree of sleep apnea will be contacted and be requested to undergo clinical evaluation and an overnight polysomnography (estimated - 100 women). This evaluation will consist of an in-depth sleep related and general medical history and physical examination including body mass measurements (height, weight, neck circumference).
Tissue and umbilical cord blood collection: Placentas will be evaluated by a single pathologist. The pathologist will be blind to the medical and perinatal history but not to gestational age. Each placenta will be examined using a criteria previously reported.
Cord blood will be obtained at birth from the double clamped umbilical vein and will be processed immediately for fetal blood gases analysis. Immediately following delivery, 5 mL of blood will be obtained from the umbilical cord of all babies.
Neuro-behavioral evaluation of the newborn will be conducted at the first 48 hours of life.
Sleep questionnaire: The questionnaire is based on validated questionnaires and includes information on snoring, sleep pauses and daytime sleepiness.Completed questionnaires will be reviewed weekly, and women with either severe daytime sleepiness or self reported frequent snoring or any degree of sleep apnea will be contacted and be requested to undergo clinical evaluation and an overnight polysomnography (estimated - 100 women). This evaluation will consist of an in-depth sleep related and general medical history and physical examination including body mass measurements (height, weight, neck circumference).
Tissue and umbilical cord blood collection: Placentas will be evaluated by a single pathologist. The pathologist will be blind to the medical and perinatal history but not to gestational age. Each placenta will be examined using a criteria previously reported.
Cord blood will be obtained at birth from the double clamped umbilical vein and will be processed immediately for fetal blood gases analysis. Immediately following delivery, 5 mL of blood will be obtained from the umbilical cord of all babies.
Neuro-behavioral evaluation of the newborn will be conducted at the first 48 hours of life.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Unknown
-
Sep 2024 — Present [monthly]
Unknown
-
Jul 2024 — Sep 2024 [monthly]
Unknown
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status
-
Apr 2018 — Jan 2021 [monthly]
Unknown Status
Phase: NA → None
▶ Show 1 earlier version
-
Jan 2017 — Apr 2018 [monthly]
Unknown Status NA
First recorded
Sep 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Israel Science Foundation
- Tel-Aviv Sourasky Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .