Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy

Sleep Apnea, Obstructive Clinical Trial

Official title:

Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356106
• Other study ID #: ID11-58-12
• Status: Completed
• Phase: N/A
• Start date: November 16, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2021
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.

Description:

Screening for sleep disordered breathing (Respiratory disturbance index, RDI ≥ 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the inclusion criteria without any of the exclusion criteria, randomization into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine is repeated at 24-28 week gestations. Subjects in both groups received standard usual care during ANC and outcomes were measured with similar case record forms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

High risk pregnant women attending the antenatal care at the collaborated hospitals will be eligible for the study if they meet all following inclusion criteria.

Inclusion criteria (ALL criteria)

1. Singleton pregnant women age = 18 years

2. Pregnant women attending the antenatal care and intending to deliver at one of the study hospitals with gestational age < 16 weeks

3. Thai nationality with ability to use Thai language proficiently both in spoken and written language.

4. Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions

1. Chronic hypertension prior to pregnancy

2. Hypertension during pregnancy before 20 weeks gestation.

3. Pre-eclampsia/gestational hypertension during recent pregnancy

4. Obesity defined by pre-pregnancy body mass index (BMI) = 27.5 kg/m2

5. History of diabetes mellitus or gestational diabetes

6. Having gestational diabetes or overt diabetes

5. Presence of snoring (either as frequent snoring =3 times/week or loud snoring) prior to or occurring during pregnancy OR respiratory disturbance index, RDI = 5 events/hour by type 2 sleep testing at either point of testing during early pregnancy (0-16 GA week) or late pregnancy (GA 24-28week ).

6. Sign written informed consent

Exclusion Criteria:

1. Subjects' unwillingness to participate in the study at any time of the study.

2. Subject with significant medical conditions such as immunocompromised status, chronic infection (HIV infection, tuberculosis), chronic lung and cardiac conditions, chronic renal failure, thyroid disease, or neuromuscular disease.

3. Subjects with extremely severe obstructive sleep apnea (RDI =30) or with significant O2 desaturation <80% during sleep that might have potential benefit from the CPAP treatment.

4. Subject with known obstructive sleep apnea and currently on CPAP treatment

Related Conditions & MeSH terms

• Apnea
• Eclampsia
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure (CPAP)
A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Ramathibodi hospital	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Ramathibodi Hospital	National Research Council of Thailand, The Development Potentials of Thai People Project, Ramathibodi hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of blood pressure	Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)	During 24-28 weeks gestation
Primary	Measurement of blood pressure	Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)	During 32-34 weeks gestation
Primary	Measurement of blood pressure	Difference of daytime mean blood pressure between 2 groups (mmHg)	During 24-28 weeks gestation
Primary	Measurement of blood pressure	Difference of daytime mean blood pressure between 2 groups(mmHg)	During 32-34 weeks gestation
Primary	Measurement of blood pressure	Difference of daytime mean blood pressure between 2 groups (mmHg)	During 18-20 weeks gestation
Primary	Measurement of blood pressure	Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)	During 18-20 weeks gestation
Secondary	24-hour ambulatory blood pressure monitoring	Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)	measured twice during 24-28 week gestation, and 32-34 week gestation
Secondary	24-hour ambulatory blood pressure monitoring	Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)	measured twice during 32-34 week gestation
Secondary	Incidence of pregnancy induced hypertension (composite outcome1)	Incidence of hypertensive disorder of pregnancy	During pregnancy until delivery
Secondary	Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)	Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section	During pregnancy until delivery
Secondary	Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)	Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death	During pregnancy until delivery
Secondary	Fasting plasma glucose	Fasting plasma glucose (mg/dL)	during 24-28 weeks gestation
Secondary	Fasting plasma glucose	Fasting plasma glucose (mg/dL)	during 32-34 weeks gestation
Secondary	Oral glucose tolerance test (OGTT)	Oral Glucose Tolerance Test (OGTT) (mg/dL)	during 24-28 weeks gestation
Secondary	Fetal ultrasound results	Fetal growth (grams)	During 24-28 weeks gestation
Secondary	Fetal ultrasound results	Fetal growth (grams)	During 32-34 weeks gestation
Secondary	Fetal ultrasound results	Uterine Doppler arterial blood flow	During 18-20 weeks gestation
Secondary	Fetal ultrasound results	Uterine Doppler arterial blood flow	During 24-28 weeks gestation
Secondary	Fetal ultrasound results	Uterine Doppler arterial blood flow	During 32-34 weeks gestation
Secondary	Neonatal birthweight	Neonatal birthweight (grams)	at delivery
Secondary	APGAR score	The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.	at 1 minute and 5 minutes after birth
Secondary	Neonatal length of stay in hospital	Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital	Through study completion up to 24 weeks
Secondary	Neonatal ICU admission rate	Neonatal ICU admission rate (%) after birth	Through study completion up to 24 weeks