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Status unknownNCT06391151Updated Jun 4, 2024

Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

An observational study in Obstructive Sleep Apnea, Chronic Tonsillitis and Pregnancy, sponsored by Peking University First Hospital. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Peking University First Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
Female
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Study summary

This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) resulting from chronic tonsillitis on pregnancy outcomes. The hypothesis posits that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.

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Conditions studied

  • Obstructive Sleep Apnea
  • Chronic Tonsillitis
  • Pregnancy
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In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's planned enrollment of 500 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 386 studies on the registry; 182 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant women who have established prenatal care records and undergone antenatal check-ups at PKUFH

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women confirmed with chronic tonsillitis by clinical diagnosis and presenting symptoms.
  • Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
  • Pregnant women who are willing to participate in the study and provide informed consent.

Exclusion criteria

Exclusion Criteria:

  • Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
  • Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
  • Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
  • Pregnant women who refuse to participate in the study or are unable to provide informed consent.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • Otherexposure: OSA resulting from chronic tonsillitis

    exposure: OSA resulting from chronic tonsillitis

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What researchers measure

Primary outcomes

  1. preterm birth rate

    Time frame: 10 months

Secondary outcomes

  1. delivery methods

    Time frame: 10 months

Other outcomes

  1. pregnancy complications

    Time frame: 10 months

  2. neonatal birth weight

    birth weight of newborns measured in grams

    Time frame: 10 months

  3. neonatal length

    length of newborns measured in centimeters

    Time frame: 10 months

  4. Apgar score of newborns

    The Apgar score consists of five main indicators: skin color, heart rate, response to stimulation, muscle tone, and respiration. Each indicator is scored from 0 to 2, with a total score of 10. This scoring method serves as a guiding tool for the resuscitation of newborns with asphyxia and could provide a degree of predictive value for the neurological development of infants in the future.

    Time frame: 10 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Individual participant data will be provided upon request.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Dec 2025, 17 months later.

Of 259 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's planned 17 months is below that.

Counting every sponsor, half of 294 studies reached it within 30 months; a quarter within 15 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
Apr 30, 2024
StartEst.
Jul 1, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jun 30, 2026
Last update
Jun 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06391151
Responsible party
Xiaowan Du (Principal Investigator, Peking University First Hospital) — Principal investigator
First posted
Apr 30, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jun 4, 2024

Study contacts

Xiaowan Du
Contact
xiaowandu26@126.com
13552834319
Xiaowan Du
study director · Peking University First Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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