Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections : an intervention development and pilot-study (INTACT-1)
(2025) In BMC Pregnancy and Childbirth 25(1).- Abstract
Background: Keeping the umbilical cord intact the first minutes after delivery is beneficial for both term and preterm infants. However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS. Methods: The intervention development process (phase 1) covered: (A) placenta delivery without cord clamping, (B) intact-cord stabilisation of the infant and (C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback... (More)
Background: Keeping the umbilical cord intact the first minutes after delivery is beneficial for both term and preterm infants. However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS. Methods: The intervention development process (phase 1) covered: (A) placenta delivery without cord clamping, (B) intact-cord stabilisation of the infant and (C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback rounds. The involved staff were trained prior to pilot-testing (phase 2). Women having a CS in regional anaesthesia, expecting a term or near-term singleton infant were included in the pilot-study after written consent. Primary outcome was the proportion of successfully completed interventions. For assessment of safety, maternal estimated intraoperative blood loss, infant 5-minute Apgar scores and infant rectal temperature during stabilisation were compared to pre-defined accept criteria. Dry-electrode ECG (NeoBeat™) was used for early detection of infant heart rate. Any respiratory support was registered. Early skin-to-skin contact between mother and infant was attempted for vigorous infants. Results: A detailed intervention protocol was developed and tested. Twenty-nine mother-infant-dyads were included in the pilot study. Gestational age ranged from 37 to 42 weeks. The intervention was successfully completed in 26 of 29 cases, of which 31% were planned CS. Median (SD) infant heart rates at one and five minutes were 159 (32) and 168 (21) beats per minute respectively. Eight infants (28%) had intact-cord respiratory support. One infant had a 5-minute Apgar score < 7 and three infants (10%) had rectal temperatures below 36.5 °C during the first 10–15 min after birth. Three mothers (10%) had estimated intraoperative blood loss > 1000 ml. Conclusion: Extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for term and near-term infants delivered by CS was feasible according to predefined accept criteria. Further investigation of safety of this complex intervention in larger, comparative studies is warranted. Trial registration: Regional Committee for Medical Research Ethics Central Norway (REK-Midt), #399101.
(Less)
- author
- Saether, Elisabeth
; Andersson, Ola
LU
; Bjellmo, Solveig ; Bernitz, Stine ; Reinhart-Van Gülpen, Friedrich ; Myklebust, Tor Åge ; Stridsklev, Solhild and Eriksen, Beate Horsberg
- organization
- publishing date
- 2025-12
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Caesarean section, Infant, Intact cord stabilisation, Placental transfusion, Umbilical cord clamping
- in
- BMC Pregnancy and Childbirth
- volume
- 25
- issue
- 1
- article number
- 550
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:40346480
- scopus:105004678721
- ISSN
- 1471-2393
- DOI
- 10.1186/s12884-025-07641-w
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © The Author(s) 2025.
- id
- 6bfb3c10-d977-491b-9c8c-a3210fdc9f4a
- date added to LUP
- 2025-06-24 14:39:09
- date last changed
- 2025-07-08 16:54:13
@article{6bfb3c10-d977-491b-9c8c-a3210fdc9f4a, abstract = {{<p>Background: Keeping the umbilical cord intact the first minutes after delivery is beneficial for both term and preterm infants. However, this may be challenging in caesarean sections (CS) due to lack of mobile resuscitation equipment, maintenance of sterility or concern for excessive maternal blood loss. The objective of this study was to develop and pilot-test extra-uterine placental transfusion and intact-cord stabilisation of infants in CS. Methods: The intervention development process (phase 1) covered: (A) placenta delivery without cord clamping, (B) intact-cord stabilisation of the infant and (C) physiology-based cord clamping. Different scenarios were tested through in-situ simulation and adjusted through multiple feedback rounds. The involved staff were trained prior to pilot-testing (phase 2). Women having a CS in regional anaesthesia, expecting a term or near-term singleton infant were included in the pilot-study after written consent. Primary outcome was the proportion of successfully completed interventions. For assessment of safety, maternal estimated intraoperative blood loss, infant 5-minute Apgar scores and infant rectal temperature during stabilisation were compared to pre-defined accept criteria. Dry-electrode ECG (NeoBeat™) was used for early detection of infant heart rate. Any respiratory support was registered. Early skin-to-skin contact between mother and infant was attempted for vigorous infants. Results: A detailed intervention protocol was developed and tested. Twenty-nine mother-infant-dyads were included in the pilot study. Gestational age ranged from 37 to 42 weeks. The intervention was successfully completed in 26 of 29 cases, of which 31% were planned CS. Median (SD) infant heart rates at one and five minutes were 159 (32) and 168 (21) beats per minute respectively. Eight infants (28%) had intact-cord respiratory support. One infant had a 5-minute Apgar score < 7 and three infants (10%) had rectal temperatures below 36.5 °C during the first 10–15 min after birth. Three mothers (10%) had estimated intraoperative blood loss > 1000 ml. Conclusion: Extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for term and near-term infants delivered by CS was feasible according to predefined accept criteria. Further investigation of safety of this complex intervention in larger, comparative studies is warranted. Trial registration: Regional Committee for Medical Research Ethics Central Norway (REK-Midt), #399101.</p>}}, author = {{Saether, Elisabeth and Andersson, Ola and Bjellmo, Solveig and Bernitz, Stine and Reinhart-Van Gülpen, Friedrich and Myklebust, Tor Åge and Stridsklev, Solhild and Eriksen, Beate Horsberg}}, issn = {{1471-2393}}, keywords = {{Caesarean section; Infant; Intact cord stabilisation; Placental transfusion; Umbilical cord clamping}}, language = {{eng}}, number = {{1}}, publisher = {{BioMed Central (BMC)}}, series = {{BMC Pregnancy and Childbirth}}, title = {{Extra-uterine placental transfusion and intact-cord stabilisation of infants in caesarean sections : an intervention development and pilot-study (INTACT-1)}}, url = {{http://dx.doi.org/10.1186/s12884-025-07641-w}}, doi = {{10.1186/s12884-025-07641-w}}, volume = {{25}}, year = {{2025}}, }