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Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes

NCT02016638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-12-20

No results posted yet for this study

Summary

Hypothesis:Sleep Disorders are very common during pregnancy but the their exact role in causation of pregnancy related disorders is yet to be determined. OSA can complicate pregnancy given the risk factors of weight gain, upper displacement of the diaphragm, and hormonal-induced hyperaemia of the nasopharyngeal passages. SDB confers the risk of hypertensive disorders of pregnancy and is associated with adverse maternal and foetal outcomes.

The study would involve pregnant females which would be prospectively followed in pregnancy and post partum to know the prevalence of sleep disorders in pregnancy. Diagnosis of sleep disorders would be confirmed by overnight polysomnography and ambulatory blood pressure monitoring. Pregnancy outcomes, both maternal and fetal would be recorded and its relation with sleep disorders in pregnancy would be analysed.

Conditions

  • Obstructive Sleep Apnea
  • Pregnancy Induced Hypertension
  • High-Risk Pregnancy
  • Restless Leg Syndrome
  • Infant, Very Low Birth Weight

Interventions

OTHER

Polysomnography and ambulatory blood pressure recording

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Surendra K Sharma, MD, Ph.D. · All India Institute of Medical Sciences

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-03-31
Completion
2014-05-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016638 on ClinicalTrials.gov