Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
Primary Purpose
Obstructive Sleep Apnea, Pregnancy Induced Hypertension, High-Risk Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Polysomnography and ambulatory blood pressure recording
Sponsored by
About this trial
This is an interventional screening trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea in pregnancy, Pregnancy induced hypertension, Restless leg syndrome, Sleep
Eligibility Criteria
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.
Sites / Locations
- All India Institute of Medical Sciences, New DelhiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
polysomnography and AMBP on pregnant females
Arm Description
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
Outcomes
Primary Outcome Measures
Sleep quality in pregnancy and its association with pregnancy outcomes
Secondary Outcome Measures
Number of patients who develop PIH and gestational diabetes
Full Information
NCT ID
NCT02016638
First Posted
December 2, 2013
Last Updated
December 19, 2013
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT02016638
Brief Title
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
Official Title
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
Prevalence of various sleep disorders in pregnancy
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)
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:
Using Somnomedic systems, GmbH polysomnography machine by trained staff nurses and technicians at:
Obstetrics ward, AIIMS hospital
Home based portable PSG in non admitted
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Pregnancy Induced Hypertension, High-Risk Pregnancy, Restless Leg Syndrome, Infant, Very Low Birth Weight
Keywords
Obstructive Sleep Apnea in pregnancy, Pregnancy induced hypertension, Restless leg syndrome, Sleep
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
polysomnography and AMBP on pregnant females
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Polysomnography and ambulatory blood pressure recording
Primary Outcome Measure Information:
Title
Sleep quality in pregnancy and its association with pregnancy outcomes
Time Frame
from recruitment during pregnancy to 6 weeks post partum
Secondary Outcome Measure Information:
Title
Number of patients who develop PIH and gestational diabetes
Time Frame
from recruitment to 6 weeks post partum
Other Pre-specified Outcome Measures:
Title
to know the prevalence of sleep disorders in pregnancy and post partum
Time Frame
from recruitment in pregnancy to 6 week post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abhimanyu Nehra, MBBS
Phone
9868057741
Email
abhimanyunehra@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Surendra K Sharma, MD, Ph.D.
Phone
26593303
Email
sksharma@aiims.ac.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra K Sharma, MD, Ph.D.
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences, New Delhi
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhimanyu Nehra, MBBS
Phone
9868057741
Email
abhimanyunehra@yahoo.com
First Name & Middle Initial & Last Name & Degree
Surendra K Sharma, MD, PH.D
First Name & Middle Initial & Last Name & Degree
Abhimanyu Nehra, MBBS
First Name & Middle Initial & Last Name & Degree
Sunesh Kumar Jain, MD
First Name & Middle Initial & Last Name & Degree
Sanjeev Sinha, MD
First Name & Middle Initial & Last Name & Degree
Vishnubhatla Sreenivas, Ph.D
First Name & Middle Initial & Last Name & Degree
Manish Soneja, MD
12. IPD Sharing Statement
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Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
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