deltatrials
Unknown OBSERVATIONAL NCT00931099

Fetal Outcome of Sleep Disordered Breathing During Pregnancy

Sponsor: Israel Science Foundation

Conditions Pregnant Women
Updated 6 times since 2017 Last updated: Jul 1, 2009 Started: Sep 30, 2009 Primary completion: Sep 30, 2012 Completion: Sep 30, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotUnknown Status~Apr 2018 – ~Jan 2021 · 33 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2024 — Present [monthly]

    Unknown

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status

  5. Apr 2018 — Jan 2021 [monthly]

    Unknown Status

    Phase: NANone

Show 1 earlier version
  1. 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

Sponsor contact:
  • Israel Science Foundation
  • Tel-Aviv Sourasky Medical Center
Data source: Tel-Aviv Sourasky Medical Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations