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Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02016638
First Posted: December 20, 2013
Last Update Posted: December 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Pregnancy Induced Hypertension High-Risk Pregnancy Restless Leg Syndrome Infant, Very Low Birth Weight Other: Polysomnography and ambulatory blood pressure recording

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes

Resource links provided by NLM:


Further study details as provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Sleep quality in pregnancy and its association with pregnancy outcomes [ Time Frame: from recruitment during pregnancy to 6 weeks post partum ]

Secondary Outcome Measures:
  • Number of patients who develop PIH and gestational diabetes [ Time Frame: from recruitment to 6 weeks post partum ]

Other Outcome Measures:
  • to know the prevalence of sleep disorders in pregnancy and post partum [ Time Frame: from recruitment in pregnancy to 6 week post partum ]

Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Other: Polysomnography and ambulatory blood pressure recording

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016638


Contacts
Contact: Abhimanyu Nehra, MBBS 9868057741 abhimanyunehra@yahoo.com
Contact: Surendra K Sharma, MD, Ph.D. 26593303 sksharma@aiims.ac.in

Locations
India
All India Institute of Medical Sciences, New Delhi Recruiting
New Delhi, India, 110029
Contact: Abhimanyu Nehra, MBBS    9868057741    abhimanyunehra@yahoo.com   
Principal Investigator: Surendra K Sharma, MD, PH.D         
Sub-Investigator: Abhimanyu Nehra, MBBS         
Sub-Investigator: Sunesh Kumar Jain, MD         
Sub-Investigator: Sanjeev Sinha, MD         
Sub-Investigator: Vishnubhatla Sreenivas, Ph.D         
Sub-Investigator: Manish Soneja, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Surendra K Sharma, MD, Ph.D. All India Institute of Medical Sciences, New Delhi
  More Information

Responsible Party: S.K.SHARMA, Professor and Head, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT02016638     History of Changes
Other Study ID Numbers: SKS/Med/Sleep_Preg
First Submitted: December 2, 2013
First Posted: December 20, 2013
Last Update Posted: December 20, 2013
Last Verified: December 2013

Keywords provided by S.K.SHARMA, All India Institute of Medical Sciences, New Delhi:
Obstructive Sleep Apnea in pregnancy
Pregnancy induced hypertension
Restless leg syndrome
Sleep

Additional relevant MeSH terms:
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Birth Weight
Psychomotor Agitation
Restless Legs Syndrome
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Body Weight
Signs and Symptoms
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Parasomnias
Mental Disorders
Pregnancy Complications