Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes

NCT02016638 | Unknown DMC

• 1 other identifier: SKS/Med/Sleep_Preg
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sleep quality in pregnancy and its association with pregnancy outcomes

  from recruitment during pregnancy to 6 weeks post partum

Secondary Outcomes (1)

• Number of patients who develop PIH and gestational diabetes

  from recruitment to 6 weeks post partum

Other Outcomes (1)

• to know the prevalence of sleep disorders in pregnancy and post partum

  from recruitment in pregnancy to 6 week post partum

Study Arms (1)

polysomnography and AMBP on pregnant females

EXPERIMENTAL

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

Interventions

Polysomnography and ambulatory blood pressure recording OTHER

polysomnography and AMBP on pregnant females

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-45 years
• Singleton pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension, Pregnancy-Induced; Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Parasomnias; Mental Disorders

Study Officials

• Surendra K Sharma, MD, Ph.D.

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhimanyu Nehra, MBBS

CONTACT

9868057741; abhimanyunehra@yahoo.com

Surendra K Sharma, MD, Ph.D.

CONTACT

26593303; sksharma@aiims.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 20, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

IN (1)