Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
NCT ID: NCT02016638
Last Updated: 2013-12-20
Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2013-03-31
2014-05-31
Brief Summary
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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
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1. To assess sleep quality during pregnancy
2. To know prevalence of various sleep disorders during pregnancy including restless leg syndrome, symptomatic obstructive sleep apnea etc.
3. To study the effect of sleep disorders on maternal and fetal outcome
4. 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.
Case: patient with OSA
Control: patients without OSA
* We proposed to determine that what proportion of the cases were exposed to sleep disorders and what proportion are not.
* We also planned to determine what proportion of controls is exposed and what proportion is not.
Cases and controls would be matched for age ,parity, BMI,previous h/o pre-eclampsia in first trimester.
Outcome parameters
1. Prevalence of various sleep disorders in pregnancy
2. Maternal outcome: Development of pregnancy induced hypertension (PIH), gestational diabetes mellitus, complicated pregnancy requiring admission, preterm delivery, ante-partum hemorrhage, delivery requiring intervention (Caesarian section, forceps/ventouse application)
3. Fetal outcome: APGAR scores at 1 and 5 min, IUGR, IUD, low birth weight
Sample Size:
A sample of convenience of 200 patients (who respond to questionnaire) and satisfy inclusion and exclusion criteria will be followed up prospectively to assess the effect of sleep disorders on pregnancy outcome.As per estimates from literature sample size for case control part would be 20 for cases and 40 controls.
Investigation specifically related to projects:
1. Using Somnomedic systems, GmbH polysomnography machine by trained staff nurses and technicians at:
* Obstetrics ward, AIIMS hospital
* Home based portable PSG in non admitted
2. Ambulatory blood pressure by the Oscar 2™ system from SunTech Medical, USA. The Oscar 2 is clinically validated to all three internationally recognized standards.
* British Hypertension Society1 (A/A)
* European Society of Hypertension International Protocol2
* AAMI SP103
Patient comfort The Oscar 2 and the Orbit™ BP cuff make patient comfort a priority.
* The SunTech Medical, Inc. patented Orbit cuff uses an innovative stretch-sleeve design to maintain cuff placement and promote patient comfort.
* The Oscar 2 is a light, compact monitor that uses motion tolerant algorithms to reduce re-inflates and failed readings. The auto-intelligent inflation pressure also reduces measurement time, promoting patient comfort by controlling cuff inflation.
3. Screening Polysomnography using Apnea linkTM PLUS
* A quick and easy sleep-screening tool designed to help identify more patients at risk for obstructive sleep apnea (OSA).
* A premium, compact device that can be used at home
Additional Investigation Required
* Routine clinical antenatal examination
* Blood pressure measurement
* Blood parameters (done routinely in ANC)
* Fasting blood sugar
* Renal and hepatic function tests
* Hemoglobin levels/s ferritin
* Serum TSH levels
* Urine examination
* Routine and spot sample for protein.
* Sonography: To rule out twin pregnancy and molar gestation/IUGR/Anomalies.
* These investigations are routinely done in ante natal clinic at AIIMS.
Data Analysis
* Data will be collected on a pre-designed proforma.
* Statistical analysis will be performed using STATA 11 for Windows software (intercooled version, Stata Corporation, Houston, TX, USA).
* After assessing for approximate normal distribution, all continuous variables will be summarized as mean ± SD or median (interquartile range).
* Categorical variables will be expressed as n (%).
* The cases and controls will be compared using unpaired t-test if the data was normally distributed and the Mann-Whitney U test if not.
* A p values of \<0.05 will be considered statistically significant.
* Confounding factors influencing pregnancy outcomes will be subject to multivariate analysis to determine significance.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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polysomnography and AMBP on pregnant females
Consecutive patients undergoing antenatal check up at the Antenatal Clinic at AIIMS hospital and obstetrics wards will be recruited and followed.Using Somnomedic systems, GmbH polysomnography machine by trained staff nurses and technicians at:
Obstetrics ward, AIIMS hospital
Polysomnography and ambulatory blood pressure recording
Interventions
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Polysomnography and ambulatory blood pressure recording
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
Exclusion Criteria
* 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
20 Years
45 Years
FEMALE
Yes
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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S.K.SHARMA
Professor and Head
Principal Investigators
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Surendra K Sharma, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences
Locations
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All India Institute of Medical Sciences, New Delhi
New Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Abhimanyu Nehra, MBBS
Role: primary
Other Identifiers
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SKS/Med/Sleep_Preg
Identifier Type: -
Identifier Source: org_study_id