Breastfeeding, ExclusiveNCT05292924
Early Versus Inmediately Skin to Skin Contact in Cesarean Section
A study testing Early SCC in people with Breastfeeding, Exclusive and Mother-Child Relations, run by Asociación Mexicana de Salud Primal.
Trial summary
Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breastfeeding, Exclusive, Mother-Child Relations, Kangaroo-mother Care
- What is being tested?
- Early SCC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria: Women between 18 and 40 years of age with a single pregnancy greater than 37 weeks of gestation with an indication for cesarean section and who agree to participate in the study.
Exclusion Criteria: Patients who are minors, multiple pregnancies, or who do not agree to participate in the study.
Elimination criteria: Participants who decide not to continue with the study, who do not answer the evaluation surveys on breastfeeding or who do not return for follow-up.
About this study
Official title: Immediate vs Early Skin-to-skin Contact in Cesarean Births and Its Effect on Breastfeeding
Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can influence its onset, proper establishment and duration. Caesarean section and instrumental delivery are directly related to a delay in the early initiation of breastfeeding in newborns. In Mexico, the rate of caesarean sections is well above that recommended by the World Health Organization, in addition to being a country with very low rates of exclusive breastfeeding at 6 months of age of the newborn without having achieved the proposed objectives to improve it in recent years.
Newborns who experience skin-to-skin contact with their mother develop behaviors such as crawling to the breast and more effective suckling with greater lactogenesis by the mother. The World Health Organization (WHO) defines skin-to-skin contact (SSC) as "direct, immediate and uninterrupted contact of the infant with the mother's skin" and promotes it because it is important for establishment of breastfeeding, neonatal and child survival and development. It has been seen that the ideal time to start this CPP is within the first 30 minutes of life of the newborn in any birth route, so it has been recommended that it be started in the recovery room or even in the operating room during birth by caesarean section in order to make a mark in the programming of the future physiology and behavior of the dyad.
The foregoing leads us to ask ourselves the following research questions: Can we in our public hospitals in Mexico carry out the CPP procedure between mother and baby during cesarean births? And if so, will there be a difference in breastfeeding by Mexican women, performing skin-to-skin contact immediately even in the operating room between mother and baby in cesarean births versus if it is carried out after the surgical procedure?
Read the detailed description
Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can influence its onset, proper establishment and duration. Caesarean section and instrumental delivery are directly related to a delay in the early initiation of breastfeeding in newborns. The cause of this effect has been related to the limitation in maternal movement, the pain of the wound or the difficulty in maternal positioning. It has also been seen that newborns by caesarean section or instrumental delivery may have more problems with attachment and inadequate suction. In Mexico, the rate of caesarean sections is well above that recommended by the World Health Organization, in addition to being a country with very low rates of exclusive breastfeeding at 6 months of age of the newborn without having achieved the proposed objectives to improve it in recent years.
Cesarean section traditionally implies a separation between the mother and her newborn, which is contrary to the recommendations to promote better breastfeeding and establishment of the bond between the mother and her baby. There is evidence that demonstrates the relationship between skin-to-skin contact and higher rates of exclusive breastfeeding. This contact between the naked baby on the naked torso of her mother as soon as possible after birth is also recommended in cesarean births as soon as possible for the mother to perform it.
Newborns who experience skin-to-skin contact with their mother develop behaviors such as crawling to the breast and more effective suckling, in addition to having the opportunity to manifest the necessary demands for attention that trigger neuropsychobiological pathways that activate maternal behaviors and a immediate response to the needs of the infant with greater lactogenesis by the mother. The World Health Organization (WHO) defines skin-to-skin contact (SSC) as "direct, immediate and uninterrupted contact of the infant with the mother's skin" and promotes it because it is important for establishment of breastfeeding, neonatal and child survival and development. It has been seen that the ideal time to start this CPP is within the first 30 minutes of life of the newborn in any birth route, so it has been recommended that it be started in the recovery room or even in the operating room during birth by caesarean section in order to make a mark in the programming of the future physiology and behavior of the dyad.
The positive short- and long-term psychosocial, economic, environmental, and physical health effects on both maternal and infant health of adequate breastfeeding are well recognized in the literature, and yet their impact on maternal health It is not fully valued in Mexico, which maintains a very low prevalence of exclusive breastfeeding at six months of life of newborns. According to UNICEF, the prevalence of exclusive breastfeeding in Mexico is only 28.8% when in other Latin American countries it reaches 66.4%, 58.3% and 53.2%, as is the case in Peru, Bolivia and Guatemala, respectively. In 2018, Mexico is reported as having one of the lowest breastfeeding rates in the world despite having had an increase from 14.4% to 28.6% at the national level in the rate of exclusive breastfeeding.
It is very important to assess the regional conditions of our population. The cause of this low tendency to breastfeed exclusively and for a long time may have different origins in our country, such as poor or inadequate information from mothers prior to birth, false beliefs or taboos, lack of adequate support for mothers after of birth and high rates of cesarean delivery. However, it is also described that during cesarean birth it is possible to carry out actions that favor the mother-child bond and the first food to the mother's womb within the first hour of life favoring better breastfeeding. This is achieved by favoring the skin-to-skin contact between mother and baby.
However, the difficulties in ensuring that mother and baby meet in SSC may vary depending on whether it is carried out in the operating room during surgery or after it in the recovery room. It is about a procedure in which the mother-baby dyad participates as the center of care, but also all the professional support staff such as nurses, anesthesiologists and staff responsible for the care of the newborn, in addition to the obstetric staff who performs the surgery.
The foregoing leads us to ask ourselves the following research questions: Can we in our public hospitals in Mexico carry out the CPP procedure between mother and baby during cesarean births? And if so, will there be a difference in breastfeeding by Mexican women, performing skin-to-skin contact immediately even in the operating room between mother and baby in cesarean births versus if it is carried out after the surgical procedure?
- Being tested
- Early SCC
- Keywords
- Birth, Cesarean Section, Skin-to-skin contact, Mother-Child Relations, Breastfeeding, kangaroo-mother care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early SCCProcedure or surgery
Direct, immediate and uninterrupted contact of the infant with its mother's skin first 30 minutes delivery
| Study group | Role | What they receive |
|---|---|---|
| Early SSC | Experimental | Cesarean delivery and SSC within the first 30 minutes of birth Receives: Procedure: Early SCC |
| Control | No intervention | Cesarean delivery and SSC one hour after birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding
Feeding to the exclusive mother's breast at least six months after birth
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study startJul 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6000 births per year were considered, of which 30% correspond to births by cesarean section. For a non-random and voluntary sampling with a homogeneous population and a sampling error of 5%, at a confidence level of 95%, the sample size is 278. Of this number of participants, 50% will be assigned to the experimental group (birth by cesarean section and EFS within the first 30 minutes of birth) and 50% to the control group (caesarean birth and EFS one hour after birth) by simple randomization.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación Mexicana de Salud Primal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Octavio Zavala Soto, Asociación Mexicana de Salud Primal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292924
- Sponsor's protocol ID
- Skin-to-Skin-cesarean
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for information can be requested with the principal investigator via email
Publications
Chien LY, Tai CJ. Effect of delivery method and timing of breastfeeding initiation on breastfeeding outcomes in Taiwan. Birth. 2007 Jun;34(2):123-30. doi: 10.1111/j.1523-536X.2007.00158.x.
PubMed 17542816Patel A, Bucher S, Pusdekar Y, Esamai F, Krebs NF, Goudar SS, Chomba E, Garces A, Pasha O, Saleem S, Kodkany BS, Liechty EA, Kodkany B, Derman RJ, Carlo WA, Hambidge K, Goldenberg RL, Althabe F, Berrueta M, Moore JL, McClure EM, Koso-Thomas M, Hibberd PL. Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study. Reprod Health. 2015;12 Suppl 2(Suppl 2):S10. doi: 10.1186/1742-4755-12-S2-S10. Epub 2015 Jun 8.
PubMed 26063291Stevens J, Schmied V, Burns E, Dahlen H. Immediate or early skin-to-skin contact after a Caesarean section: a review of the literature. Matern Child Nutr. 2014 Oct;10(4):456-73. doi: 10.1111/mcn.12128. Epub 2014 Apr 10.
PubMed 24720501Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean childbirth. Midwifery. 2014 Jun;30(6):712-9. doi: 10.1016/j.midw.2013.10.014. Epub 2013 Oct 26.
PubMed 24252711Lau Y, Htun TP, Lim PI, Ho-Lim S, Klainin-Yobas P. Maternal, Infant Characteristics, Breastfeeding Techniques, and Initiation: Structural Equation Modeling Approaches. PLoS One. 2015 Nov 13;10(11):e0142861. doi: 10.1371/journal.pone.0142861. eCollection 2015.
PubMed 26566028Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.
PubMed 27118118Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20.
PubMed 27917213Brimdyr K, Cadwell K, Stevens J, Takahashi Y. An implementation algorithm to improve skin-to-skin practice in the first hour after birth. Matern Child Nutr. 2018 Apr;14(2):e12571. doi: 10.1111/mcn.12571. Epub 2017 Dec 12.
PubMed 29230957Schneider LW, Crenshaw JT, Gilder RE. Influence of Immediate Skin-to-Skin Contact During Cesarean Surgery on Rate of Transfer of Newborns to NICU for Observation. Nurs Womens Health. 2017 Feb-Mar;21(1):28-33. doi: 10.1016/j.nwh.2016.12.008.
PubMed 28187837Debes AK, Kohli A, Walker N, Edmond K, Mullany LC. Time to initiation of breastfeeding and neonatal mortality and morbidity: a systematic review. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S19. doi: 10.1186/1471-2458-13-S3-S19. Epub 2013 Sep 17.
PubMed 24564770Cantrill RM, Creedy DK, Cooke M, Dykes F. Effective suckling in relation to naked maternal-infant body contact in the first hour of life: an observation study. BMC Pregnancy Childbirth. 2014 Jan 14;14:20. doi: 10.1186/1471-2393-14-20.
PubMed 24423381Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016 Aug 23;2016(8):CD002771. doi: 10.1002/14651858.CD002771.pub4.
PubMed 27552521Ip S, Chung M, Raman G, Chew P, Magula N, DeVine D, Trikalinos T, Lau J. Breastfeeding and maternal and infant health outcomes in developed countries. Evid Rep Technol Assess (Full Rep). 2007 Apr;(153):1-186.
PubMed 17764214Yi DY, Kim SY. Human Breast Milk Composition and Function in Human Health: From Nutritional Components to Microbiome and MicroRNAs. Nutrients. 2021 Sep 2;13(9):3094. doi: 10.3390/nu13093094.
PubMed 34578971Hauck YL, Fenwick J, Dhaliwal SS, Butt J. A Western Australian survey of breastfeeding initiation, prevalence and early cessation patterns. Matern Child Health J. 2011 Feb;15(2):260-8. doi: 10.1007/s10995-009-0554-2.
PubMed 20077131
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs Early Skin-to-skin Contact in Cesarean Births and Its Effect on Breastfeeding
- ClinicalTrials.gov ID
- NCT05292924
- Acronym / sponsor ID
- Skin-to-Skin-cesarean
- Keywords
- Birth, Cesarean Section, Skin-to-skin contact, Mother-Child Relations, Breastfeeding, kangaroo-mother care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Asociación Mexicana de Salud PrimalUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can influence its onset, proper establishment and duration. Caesarean section and instrumental delivery are directly related to a delay in the early initiation of breastfeeding in newborns. In Mexico, the rate of caesarean sections is well above that recommended by the World Health Organization, in addition to being a country with very low rates of exclusive breastfeeding at 6 months of age of the newborn without having achieved the proposed objectives to improve it in recent years.
Newborns who experience skin-to-skin contact with their mother develop behaviors such as crawling to the breast and more effective suckling with greater lactogenesis by the mother. The World Health Organization (WHO) defines skin-to-skin contact (SSC) as "direct, immediate and uninterrupted contact of the infant with the mother's skin" and promotes it because it is important for establishment of breastfeeding, neonatal and child survival and development. It has been seen that the ideal time to start this CPP is within the first 30 minutes of life of the newborn in any birth route, so it has been recommended that it be started in the recovery room or even in the operating room during birth by caesarean section in order to make a mark in the programming of the future physiology and behavior of the dyad.
The foregoing leads us to ask ourselves the following research questions: Can we in our public hospitals in Mexico carry out the CPP procedure between mother and baby during cesarean births? And if so, will there be a difference in breastfeeding by Mexican women, performing skin-to-skin contact immediately even in the operating room between mother and baby in cesarean births versus if it is carried out after the surgical procedure?
Detailed description
Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can influence its onset, proper establishment and duration. Caesarean section and instrumental delivery are directly related to a delay in the early initiation of breastfeeding in newborns. The cause of this effect has been related to the limitation in maternal movement, the pain of the wound or the difficulty in maternal positioning. It has also been seen that newborns by caesarean section or instrumental delivery may have more problems with attachment and inadequate suction. In Mexico, the rate of caesarean sections is well above that recommended by the World Health Organization, in addition to being a country with very low rates of exclusive breastfeeding at 6 months of age of the newborn without having achieved the proposed objectives to improve it in recent years.
Cesarean section traditionally implies a separation between the mother and her newborn, which is contrary to the recommendations to promote better breastfeeding and establishment of the bond between the mother and her baby. There is evidence that demonstrates the relationship between skin-to-skin contact and higher rates of exclusive breastfeeding. This contact between the naked baby on the naked torso of her mother as soon as possible after birth is also recommended in cesarean births as soon as possible for the mother to perform it.
Newborns who experience skin-to-skin contact with their mother develop behaviors such as crawling to the breast and more effective suckling, in addition to having the opportunity to manifest the necessary demands for attention that trigger neuropsychobiological pathways that activate maternal behaviors and a immediate response to the needs of the infant with greater lactogenesis by the mother. The World Health Organization (WHO) defines skin-to-skin contact (SSC) as "direct, immediate and uninterrupted contact of the infant with the mother's skin" and promotes it because it is important for establishment of breastfeeding, neonatal and child survival and development. It has been seen that the ideal time to start this CPP is within the first 30 minutes of life of the newborn in any birth route, so it has been recommended that it be started in the recovery room or even in the operating room during birth by caesarean section in order to make a mark in the programming of the future physiology and behavior of the dyad.
The positive short- and long-term psychosocial, economic, environmental, and physical health effects on both maternal and infant health of adequate breastfeeding are well recognized in the literature, and yet their impact on maternal health It is not fully valued in Mexico, which maintains a very low prevalence of exclusive breastfeeding at six months of life of newborns. According to UNICEF, the prevalence of exclusive breastfeeding in Mexico is only 28.8% when in other Latin American countries it reaches 66.4%, 58.3% and 53.2%, as is the case in Peru, Bolivia and Guatemala, respectively. In 2018, Mexico is reported as having one of the lowest breastfeeding rates in the world despite having had an increase from 14.4% to 28.6% at the national level in the rate of exclusive breastfeeding.
It is very important to assess the regional conditions of our population. The cause of this low tendency to breastfeed exclusively and for a long time may have different origins in our country, such as poor or inadequate information from mothers prior to birth, false beliefs or taboos, lack of adequate support for mothers after of birth and high rates of cesarean delivery. However, it is also described that during cesarean birth it is possible to carry out actions that favor the mother-child bond and the first food to the mother's womb within the first hour of life favoring better breastfeeding. This is achieved by favoring the skin-to-skin contact between mother and baby.
However, the difficulties in ensuring that mother and baby meet in SSC may vary depending on whether it is carried out in the operating room during surgery or after it in the recovery room. It is about a procedure in which the mother-baby dyad participates as the center of care, but also all the professional support staff such as nurses, anesthesiologists and staff responsible for the care of the newborn, in addition to the obstetric staff who performs the surgery.
The foregoing leads us to ask ourselves the following research questions: Can we in our public hospitals in Mexico carry out the CPP procedure between mother and baby during cesarean births? And if so, will there be a difference in breastfeeding by Mexican women, performing skin-to-skin contact immediately even in the operating room between mother and baby in cesarean births versus if it is carried out after the surgical procedure?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 6000 births per year were considered, of which 30% correspond to births by cesarean section. For a non-random and voluntary sampling with a homogeneous population and a sampling error of 5%, at a confidence level of 95%, the sample size is 278. Of this number of participants, 50% will be assigned to the experimental group (birth by cesarean section and EFS within the first 30 minutes of birth) and 50% to the control group (caesarean birth and EFS one hour after birth) by simple randomization.
| Arm | Type | Receives |
|---|---|---|
| Early SSC | Experimental | Procedure: Early SCCCesarean delivery and SSC within the first 30 minutes of birth |
| Control | No intervention | –Cesarean delivery and SSC one hour after birth |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early SCCDirect, immediate and uninterrupted contact of the infant with its mother's skin first 30 minutes delivery | Procedure or surgery | Early SSC |
Primary outcome
Breastfeeding
Time frame: Six months
Feeding to the exclusive mother's breast at least six months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 17542816Chien LY, Tai CJ. Effect of delivery method and timing of breastfeeding initiation on breastfeeding outcomes in Taiwan. Birth. 2007 Jun;34(2):123-30. doi: 10.1111/j.1523-536X.2007.00158.x.
- Background: PubMed 26063291Patel A, Bucher S, Pusdekar Y, Esamai F, Krebs NF, Goudar SS, Chomba E, Garces A, Pasha O, Saleem S, Kodkany BS, Liechty EA, Kodkany B, Derman RJ, Carlo WA, Hambidge K, Goldenberg RL, Althabe F, Berrueta M, Moore JL, McClure EM, Koso-Thomas M, Hibberd PL. Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study. Reprod Health. 2015;12 Suppl 2(Suppl 2):S10. doi: 10.1186/1742-4755-12-S2-S10. Epub 2015 Jun 8.
- Background: PubMed 24720501Stevens J, Schmied V, Burns E, Dahlen H. Immediate or early skin-to-skin contact after a Caesarean section: a review of the literature. Matern Child Nutr. 2014 Oct;10(4):456-73. doi: 10.1111/mcn.12128. Epub 2014 Apr 10.
- Background: PubMed 24252711Tully KP, Ball HL. Maternal accounts of their breast-feeding intent and early challenges after caesarean childbirth. Midwifery. 2014 Jun;30(6):712-9. doi: 10.1016/j.midw.2013.10.014. Epub 2013 Oct 26.
- Background: PubMed 26566028Lau Y, Htun TP, Lim PI, Ho-Lim S, Klainin-Yobas P. Maternal, Infant Characteristics, Breastfeeding Techniques, and Initiation: Structural Equation Modeling Approaches. PLoS One. 2015 Nov 13;10(11):e0142861. doi: 10.1371/journal.pone.0142861. eCollection 2015.
- Background: PubMed 27118118Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.
- Background: PubMed 27917213Sharma A. Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial. Afr Health Sci. 2016 Sep;16(3):790-797. doi: 10.4314/ahs.v16i3.20.
- Background: PubMed 29230957Brimdyr K, Cadwell K, Stevens J, Takahashi Y. An implementation algorithm to improve skin-to-skin practice in the first hour after birth. Matern Child Nutr. 2018 Apr;14(2):e12571. doi: 10.1111/mcn.12571. Epub 2017 Dec 12.
- Background: PubMed 28187837Schneider LW, Crenshaw JT, Gilder RE. Influence of Immediate Skin-to-Skin Contact During Cesarean Surgery on Rate of Transfer of Newborns to NICU for Observation. Nurs Womens Health. 2017 Feb-Mar;21(1):28-33. doi: 10.1016/j.nwh.2016.12.008.
- Background: PubMed 24564770Debes AK, Kohli A, Walker N, Edmond K, Mullany LC. Time to initiation of breastfeeding and neonatal mortality and morbidity: a systematic review. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S19. doi: 10.1186/1471-2458-13-S3-S19. Epub 2013 Sep 17.
- Background: PubMed 24423381Cantrill RM, Creedy DK, Cooke M, Dykes F. Effective suckling in relation to naked maternal-infant body contact in the first hour of life: an observation study. BMC Pregnancy Childbirth. 2014 Jan 14;14:20. doi: 10.1186/1471-2393-14-20.
- Background: PubMed 27552521Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016 Aug 23;2016(8):CD002771. doi: 10.1002/14651858.CD002771.pub4.
- Guía para la aplicación: proteger, promover y apoyar la lactancia materna en los establecimientos que prestan servicios de maternidad y neonatología - Revisión de la Iniciativa Hospitales Amigos del Niño 2018Link provided by the sponsor.
- Contacto Piel a Piel en cesáreasaLink provided by the sponsor.
- Practicas de lactancia materna en México.Unicef. Instituto nacional de Salud Publica. 2015 Encuesta Nacional de Niñas, niños y mujeresLink provided by the sponsor.
- Pinzamiento temprano vs tardío del cordón umbilical y contacto piel a piel inmediato en nacimientos por cesárea.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Requests for information can be requested with the principal investigator via email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early SCC in people with Breastfeeding, Exclusive and Mother-Child Relations, run by Asociación Mexicana de Salud Primal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292924, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.