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Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.

Episodes of Decreased Oxygen Saturation in Newborns in Skin-to-skin Contact: Role of Maternal Position After Delivery. A Randomized Clinical Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02585492
Enrollment
1243
Registered
2015-10-23
Start date
2015-11-30
Completion date
2018-04-30
Last updated
2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Disorder

Brief 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.

Detailed description

The early skin to skin contact between mother and child in the first two hours postpartum is essential for bonding and breastfeeding. Coinciding with the widespread application of this procedure in hospitals have been described, in different countries, cases of children who have suffered episodes of apparent life threatening events (ALTEs) or early sudden deaths during the same procedure. The cause of these events is unclarified, it is unknown whether the position of the mother during the first two hours of a child's life affects their stability. The investigators's hypothesis is that the frequency of episodes of oxygen saturation less than 91% in the first 2 hours of life of the newborn is reduced by one third in children whose mothers are incorporated at 45° above the horizontal plane of the bed compared with children whose mothers are incorporated to 15º. This is a multicenter, randomized and controlled study in 10 Spanish hospitals with blind evaluation. 5866 participants will be enrolled in this study (a total of 1275 children are required in each arm of the study). Mother/child (defined as a dyad) will be randomized in two groups: Group A: head-of-bed elevated 15°. Group B: head-of-bed elevated 45°.

Interventions

OTHERHead-of-bed elevated 15°

Head-of-bed elevated 15° during 2 hours after delivery.

OTHERHead-of-bed elevated 45°

Head-of-bed elevated 45° during 2 hours after delivery.

Sponsors

Hospital Universitario 12 de Octubre
CollaboratorOTHER
Red Salud Materno Infantil y del Desarrollo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
259 Days to 293 Days
Healthy volunteers
Yes

Inclusion criteria

1. Single fetus pregnancy 2. Pregnancy controlled or partially controlled(1) 3. Normal pregnancy or with gestational diabetes treated with diet, high blood pressure controlled with only a drug as maximum (without preeclampsia) 4. Gestation to term (between 37 weeks to 41 weeks and 6 days of gestational age). 5. Maternal temperature at onset of labor ≤38 degrees Celsius 6. Presence of a companion during the 2 hours after delivery 7. Desire of the mother to perform early skin-to-skin

Exclusion criteria

pre-randomization: 1. Consumption of tobacco, alcohol, drugs or any medication with sedative or relaxing(2) effect or any pathology during pregnancy. 2. Prenatal diagnosis of chromosomal abnormalities or major malformations. 3. 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 ...). 4. No companion during the first two hours postpartum Notes: 1. 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 ...). 2. Medicinal products with sedative or relaxing effect: opioids, anticonvulsants, antipsychotics, benzodiazepines, anxiolytics, hypnotics, antidepressants and sedative plants. Post randomization

Design outcomes

Primary

MeasureTime frameDescription
Presence of at least one episode desaturation ≤90%Two first hours after deliveryThe evaluation will be done with a pulse oximeter (non-invasive Radical-7 Signal Extraction PulseCO-Oximeter equipped with Masimo Rainbow SET technology). All the technology used in all hospitals is part of Masimo's SafeyNet system.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026