Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes (NCT02016638) | Clinical Trial Compass
UnknownNot Applicable
Sleep Quality in Pregnancy and Its Impact on Pregnancy Outcomes
India200 participantsStarted 2013-03
Plain-language 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.
Who can participate
Age range
20 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep quality in pregnancy and its association with pregnancy outcomes
Timeframe: from recruitment during pregnancy to 6 weeks post partum