Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels. (NCT02585492) | Clinical Trial Compass
CompletedNot Applicable
Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
Spain1,243 participantsStarted 2015-11
Plain-language summary
The purpose of this study is to determine if the position of the mother in the first two hours after delivery, while she is in skin to skin contact with your child, influences the oxygen saturation and/or heart rate of the newborn. In this way it could provide some useful information for the prevention of seemingly lethal episodes or sudden death of the child when, following current recommendations is skin to skin contact in the first hours of life. These episodes are communicating in all developed countries and have caused great concern and interest in the scientific community. So far we only have information from case series.
Who can participate
Age range259 Days – 293 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Single fetus pregnancy
✓. Pregnancy controlled or partially controlled(1)
✓. Normal pregnancy or with gestational diabetes treated with diet, high blood pressure controlled with only a drug as maximum (without preeclampsia)
✓. Gestation to term (between 37 weeks to 41 weeks and 6 days of gestational age).
✓. Maternal temperature at onset of labor ≤38 degrees Celsius
✓. Presence of a companion during the 2 hours after delivery
✓. Desire of the mother to perform early skin-to-skin
Exclusion criteria
✕. Consumption of tobacco, alcohol, drugs or any medication with sedative or relaxing(2) effect or any pathology during pregnancy.
✕. Prenatal diagnosis of chromosomal abnormalities or major malformations.
✕
What they're measuring
1
Presence of at least one episode desaturation ≤90%
Timeframe: Two first hours after delivery
Trial details
NCT IDNCT02585492
SponsorRed Salud Materno Infantil y del Desarrollo
. Prenatal diagnosis of intrauterine growth restriction with any degree of alteration in the flow as well as the abnormal small-for-gestational-age fetuses (due to malformations, intrauterine infection ...).
✕. No companion during the first two hours postpartum
✕. Partially controlled pregnancy: she has the 20 weeks ultrasound but lack the first and/or third trimester of pregnancy and/or analytical (serology, O'Sullivan test ...).
✕. Medicinal products with sedative or relaxing effect: opioids, anticonvulsants, antipsychotics, benzodiazepines, anxiolytics, hypnotics, antidepressants and sedative plants.