Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Sleep quality in pregnancy and its association with pregnancy outcomes
Study Overview
Brief 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.
Detailed Description
Objectives
- To assess sleep quality during pregnancy
- To know prevalence of various sleep disorders during pregnancy including restless leg syndrome, symptomatic obstructive sleep apnea etc.
- To study the effect of sleep disorders on maternal and fetal outcome
- To study the relation of obstructive sleep apnea with pregnancy induced hypertension.
Material & Methods
Study Design: Longitudinal prospective case-control study
- Consecutive patients undergoing antenatal check up at the Antenatal Clinic at AIIMS hospital during will be evaluated using questionnaires for sleep quality. Preliminary screening question for sleep disturbance in pregnancy to all patients
- Questionnaires used: Pittsburgh Sleep Quality Index (covers insomnia, RLS, snoring and sleep related breathing disorders); Epworth Sleepiness Score (for Excessive daytime sleepiness); Modified Wisconsin Score; Modified Berlin Questionnaires
- To now association between Obstructive sleep apnea and pregnancy induced hypertension patients who develop symptomatic OSA will be offered polysomnographic evaluation during the second/third trimester.
- An offer of similar services will be made to pregnant females who do not develop pregnancy induced hypertension at a similar gestational age.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 20-45 years
- •Singleton pregnancy
Exclusion Criteria
- •Known hypertensives i.e SBP>140/DBP>90/on anti-hypertensive medications prior to pregnancy
- •Known diabetics (FBS>100, 75 g OGTT positive/on medications)
- •Hypothyroidism
- •Chronic renal failure
- •Chronic liver disease
- •Twin pregnancy
- •Known systemic inflammatory condition e.g APLA Syndrome,SLE
- •Molar gestation
- •Patients on nephrotoxic medications e.g.NSAIDS
- •Exclusion criteria for case control part only.
Outcomes
Primary Outcomes
Sleep quality in pregnancy and its association with pregnancy outcomes
Time Frame: from recruitment during pregnancy to 6 weeks post partum
Secondary Outcomes
- Number of patients who develop PIH and gestational diabetes(from recruitment to 6 weeks post partum)
Investigators
S.K.SHARMA
Professor and Head
All India Institute of Medical Sciences, New Delhi