Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact

NCT ID: NCT04881071

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-07-21

Brief Summary

The skin-to-skin contact maneuver (kangaroo) has shown benefits in newborn babies. This is two-arm randomized open clinical trial to evaluate whether the use of a scarf specifically designed to facilitate the skin-to-skin method is effective in terms of increasing the skin-to-skin mother-neonate time, compared to traditional clinical practice. Mothers of full-term babies with expected delivery in the study centers will be included. Those mothers with a language barrier that prevents collaboration in the study procedures, cognitive impairment or morbid obesity will be excluded. The primary endpoint is the average daily skin-to-skin time during hospital admission days. A superiority analysis will be made in terms of the skin-to-skin time of the intervention arm, compared to the control arm.

Conditions

Full-term Newborn Babies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Scarf

Two hours after delivery, mothers will be informed of the benefits of the skin-to-skin method, and the towel with which mother and newborn are covered from the moment of delivery will be replaced by a NeoBulleⓇ scarf. This scarf, which can be used by the mother and/or her partner, is specific for practicing the "skin-to-skin" technique. It facilitates breastfeeding posture, keeps the newborn well covered and supported on the back. The NeoBulleⓇ scarf is not a baby carrier device that allows standing or walking without holding the baby with the arms. Nursing staff will ensure the proper understanding of scarf usage instructions by parents and provide them with written instructions. Mother and newborn will remain with the NeoBulleⓇ scarf placed in the delivery area until they are transferred to the hospitalization unit. Once in the hospitalization unit, mothers will have the option to continue contact with the baby using the scarf or dress the newborn.

Group Type: EXPERIMENTAL

Scarf

Intervention Type: DEVICE

Scarf specifically designed to facilitate mother-neonate skin-to-skin contact

Usual clinical practice

Two hours after delivery, mothers will be informed about the benefits of the skin-to-skin method, and the traditional practice in the study centers will be followed, whereby the newborn remains in contact with the mother, covered by a towel, from the moment of birth until both are transferred to the hospitalization unit. In the hospitalization unit, they will have the option to continue in this manner or dress the newborn.

Group Type: ACTIVE_COMPARATOR

Usual clinical practice

Intervention Type: OTHER

Participants will receive the usual clinical practice

Interventions

Scarf

Scarf specifically designed to facilitate mother-neonate skin-to-skin contact

Intervention Type: DEVICE

Usual clinical practice

Participants will receive the usual clinical practice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Moders attending the first hospital visit with the midwife, with delivery planned in either of the two study hospitals

Exclusion Criteria

• Language barrier that prevents collaboration in the study procedures
• Cognitive impairment preventing collaboration in the study procedures
• Morbid obesity

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Bernadó

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari Alt Penedes i Garraf

Alejandro Rodríguez-Molinero

Role: STUDY_DIRECTOR

Consorci Sanitari Alt Penedes i Garraf

Locations

Consorci Sanitari Alt Penedes i Garraf

Sant Pere de Ribes, Barcelona, Spain

Countries

Spain

References

Bernado Vidal M, Galvez-Barron C, Perez-Lopez C, Adridar F, Mayol Fiol M, Ponce Molina MP, Herzog de Samaniego V, Saiz Sanz L, Miro B, Perez-Hoyos S, Torres Soto AJ, Martinez Dalmases R, Calero Bajoz T, Rodriguez-Molinero A. A specifically designed handkerchief for skin-to-skin care: A randomized controlled trial in Spain. Int J Gynaecol Obstet. 2025 Nov 11. doi: 10.1002/ijgo.70635. Online ahead of print.

Reference Type: RESULT

PMID: 41216986 (View on PubMed)

Other Identifiers

CSAPG-14

Identifier Type: -

Identifier Source: org_study_id