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NL: Huid-op-huid contact tussen moeders en hun voldragen baby’s EN: Skin-to-skin contact in mothers and their full-term infants

NL: Huid-op-huid contact om uitkomsten in moeders en hun voldragen baby’s te bevorderen: Een gerandomiseerd onderzoek met controlegroep EN: Skin-to-skin contact to improve outcomes in mothers and their full-term infants: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22220
Enrollment
116
Registered
2016-03-13
Start date
2016-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Mothers who just gave birth to their child.

Interventions

Mothers in the skin-to-skin contact condition will be requested and encouraged to provide at least one daily and continuous hour of skin-to-skin contact to their infant for the first 5-weeks after bir

Sponsors

Radboud University and the Behavioural Science Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mothers who just gave birth to their child; 2. Aged ≥ 18; 3. Singleton pregnancy; 4. Infant born at ≥ 37 weeks of pregnancy; 5. Infant birth weight ≥ 2500 gram; 6. Infant ≥7 5-min Apgar score.

Exclusion criteria

Exclusion criteria: 1. Drug use during pregnancy; 2. Severe maternal physical or mental health problems; 3. Insufficient understanding of Dutch; 4. Congenital anomalies.

Design outcomes

Primary

MeasureTime frame
Maternal outcomes 1. Mental health: 1.1 Depressive symptoms: Edinburgh Postnatal Depression Scale (EPDS) at week 2, week 5, week 12, and year 1

Secondary

MeasureTime frame
Maternal outcomes 1. Mental health: 1.2 Anxiety: The State-Trait Anxiety Inventory (STAI) at week 2, week 5, week 12, and year 1. 1.3 Stress: The Alledaagse Problemen Lijst (APL) at week 2, week 5, week 12, and year 1. 1.4 Traumatic stress related to the delivery: The Traumatic Event Scale-B (TES-B) at week 2, week 5, week 12, and year 1. 1.5 Sleep quality: An adjusted version of the Karolinska Sleep Diary (KSD) for three consecutive days at week 2, week 5, and week 12. The Pittsburgh Sleep Quality Index (PSQI) at week 12 and year 1. 2. Physical health: 2.1 Physical recovery related to birth: The maternal physical recovery logbook of the maternity carer from the first week after birth will be copied at the home visit in week 5. The Multidimensional Fatigue Inventory (MFI) and the Bodily Pain subscale of the Short Form Health Survey (SF-36) at week 2, week 5, week 12, and year 1. 2.2 Health (illnesses and health problems): The maternal health interview, based on the infant health interview (Beijers, Jansen, Riksen-Walraven, & de Weerth, 2010), during the home visit at week 5. The mother will fill out health questionnaires, based on the infant health interview, at week 12 and year 1 (Beijers et al., 2010). 2.3 Breastfeeding: The mother will note breastfeeding frequency and duration in a weekly logbook for the first twelve weeks after birth. Mothers will note the current feeding status at year 1. 2.4 Physiological stress: A small sample of hair will be collected during the home visit in week 5. 3. Mother-infant relationship: 3.1 Bonding to the infant: The Maternal Postnatal Attachment Scale (MPAS) at week 2, week 5, week 12, and year 1. 3.2.1 Quality of maternal caregiving behavior (sensitivity): Maternal sensitivity will be observed, by the Ainsworth Sensitivity Scales, during a bathing session of the child by the mother at the home visit in week 5. 3.2.2 Quality of maternal caregiving behavior (synchrony): Synchrony will be measured with saliva samp

Contacts

Public ContactKelly Cooijmans

Radboud University - Developmental Psychology

Mail: k.cooijmans@psych.ru.nlTel. 024 361 2658

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)