Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT02016638
First received: December 2, 2013
Last updated: December 19, 2013
Last verified: December 2013
  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: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients who develop PIH and gestational diabetes [ Time Frame: from recruitment to 6 weeks post partum ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 2, 2013
Last Updated: December 19, 2013
Health Authority: India: Institutional Review Board

Keywords provided by 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, Pregnancy-Induced
Pregnancy Complications
Sleep Apnea, Obstructive
Birth Weight
Hypertension
Restless Legs Syndrome
Sleep Apnea Syndromes
Syndrome
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Body Weight
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Parasomnias
Mental Disorders
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014