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

NCT02585492 | Completed

• 1 other identifier: Neonatologia-2014-02
• Study Type: interventional
• Target: 1,243
• Locations: 1 country
• Sites: 7

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.

Conditions

Neonatal Disorder

Outcome Measures

Primary Outcomes (1)

• Presence of at least one episode desaturation ≤90%

  The 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.

  Two first hours after delivery

Study Arms (2)

head-of-bed elevated 15°

ACTIVE COMPARATOR

Mother's head-of-bead elevated 15°. Intervention: Head-of-bed elevated 15° during 2 hours after the delivery.

Other: Head-of-bed elevated 15°

head-of-bed elevated 45°

EXPERIMENTAL

Mother's head-of-bead elevated 45°. Intervention: Head-of-bed elevated 45°during 2 hours after delivery.

Other: Head-of-bed elevated 45°

Interventions

Head-of-bed elevated 15° OTHER

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

head-of-bed elevated 15°

Head-of-bed elevated 45° OTHER

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

head-of-bed elevated 45°

Eligibility Criteria

• Age: 259 Days - 293 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• Notes:
• 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.
• Related to childbirth:
• Caesarean section or instrumental delivery (forceps, vacuum)
• Maternal fever \>38 degrees Celsius
• Mother hemodynamic instability (hypotension, tachycardia, altered level of consciousness, poor perfusion, striking pallor)
• Cord prolapse
• Signs of fetal distress with lower pH fetal scalp \<7.25 or umbilical artery pH \<7.20
• Any other obstetrical complication
• Related mother:

Sponsors & Collaborators

• Red Salud Materno Infantil y del Desarrollo: lead
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (7)

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario de Cruces

Bilbao, Vizcaya, 48903, Spain

Location

Hospital de Vielha

Lleida, 25530, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Quirón

Madrid, 28223, Spain

Location

Hospital La Fe

Valencia, 46022, Spain

Location

Related Publications (1)

• Rodriguez Lopez J, Garcia Lara NR, Lopez Maestro M, De la Cruz Bertolo J, Martinez Avila JC, Vento M, Parra Llorca A, Izquierdo Macian I, Pellicer A, Marin Huarte N, Asla Elorriaga I, Roman Echevarria L, Copons Fernandez C, Martin Ancel A, Cabanas F, Garcia Algar O, Pallas Alonso CR. What is the impact of mother's bed incline on episodes of decreased oxygen saturation in healthy newborns in skin-to-skin contact after delivery: Study protocol for a randomized controlled trial. Trials. 2019 Mar 20;20(1):179. doi: 10.1186/s13063-019-3256-0.

  PMID: 30894206 DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nadia R. García Lara, Dra

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)