Breastfeeding, ExclusiveNCT04052984
Interventions That Promote Exclusive Breastfeeding
A study testing Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section in people with Breastfeeding, Exclusive, run by Asociacion Mexicana de Nacimiento Respetado, A.C..
Trial summary
Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits. However, in caesarean sections it is not common. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive
- What is being tested?
- Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Feb 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Controlled pregnancies
- Pregnancies not complicated
- Single product
- Signed the informed consent to participate in the protocol
- Product obtained by caesarean section.
Who cannot join
- Patients who did not wish to participate in the study
- Infants with prenatally suspected or diagnosticated congenital defects
- Multiple pregnancy
- Cases requesting to collect umbilical cord blood for storage in a cord cell bank
- Vaginal delivery
About this study
Official title: Delayed Cord Clamping and Early Skin-to-skin Contact in Cesarean Section as Interventions That Promote Exclusive Breastfeeding
Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits. However, in caesarean sections it is not common.
The investigators evaluate twenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section (intervention grup), compared to the same number of pairs attended by the same group of physicians under traditional techniques (control group). In both groups, morbidity and mortality as well as sole breastfeeding was evaluated for at least 6 months. The patients in the intervention group signed an informed consent form and the protocol was approved by an ethics committee.
Read the detailed description
BACKGROUND: Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits for the mother-child binomial. The American Academy of Pediatrics, through the neonatal resuscitation program, considers that late clamping should be a common practice in all healthy babies, but in the case of a baby at risk, it recommends cutting the umbilical cord early and treating newborn on radiant warmer for resuscitation. Caesarean birth is considered a risk factor.
In Mexico and in many other countries early contact, skin to skin between the mother and child in Cesarean sections, is not common.
The World Health Organization (WHO), among multiple strategies to promote breastfeeding, promotes skin-to-skin contact at birth, that is: "to place babies with their mothers since birth minimal an hour or until the baby has been fed to the mother's breast". Different publications has determined that the ideal period to strengthen breastfeeding corresponds to the first minutes of life and does not go beyond the first 2 hours. Because it is usual to take care of the baby in radiant warmer, away from his mother, in caesarean sections, these recommendations are generally not met.
Searching the benefit of delayed cut of the umbilical cord, researchers began placing healthy babies in their mother's chest, even in cesarean deliveries, thus generating immediate skin-to-skin contact and incidentally an increase in the frequency of breastfeeding during the first six months, so a protocol was initiated to compare the morbidity and mortality of this technique in relation to traditional care (immediate cut of the umbilical cord and separation mother-child) and follow-up of babies at least six months to register the form of breastfeeding.
MATERIAL AND METHODS: Pilot study. All healthy mother-neonates binomials, obtained by caesarean section by the same medical team in 3 private hospitals, born between January 2015 and August 2017 in Villahermosa, Tabasco, Mexico followed for a minimum of 6 months in the private consultation were included. They were compared with an equal number of historical binomials, attended by the same medical team under the traditional technique and with the same follow-up time. The variables in this group were collected from their files.
By protocol of the medical group in both groups, it was encouraged to carry out an adequate program of exclusive breastfeeding, as marked by the World Health Organization consisting of starting breastfeeding in the first hour of life, that the Infant only received breast milk excluding other beverages such as water, teas or food, that breastfeeding was made on demand, as often as the child wanted both day and night and no bottles or pacifiers were used during his hospital stay.
The statistical evaluation included univariate analysis with frequencies and proportions for qualitative variables, measures of central tendency and dispersion for qualitative variables. In the bivariate analysis, X2 (or Fisher's Exact test) and Student's t (or Mann Whitney U) were used, as appropriate.
- Conditions
- Breastfeeding, Exclusive
- Being tested
- Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section
- Keywords
- Cesarean Section, Umbilical cord, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean sectionProcedure or surgery
Mother: Placement of the insulating surgical arch was on the skin, between the abdomen and the thorax, electrocautery plate on the back, the gown superimposed, non-invasive blood pressure monitoring in legs and ear oximetry. The newborn was placed immediately on the mother's chest, passing it under the insulating arch and removing the mother's gown. Non-invasive monitoring was initiated with preductal pulse oximetry. The obstetrician cut the umbilical cord by not feeling the beats of the cord, or until 5 minutes. The newborn was reanimated without separating the baby from his mother. The temperature was taken with an infrared thermometer. Pulse oximetry was recorded. The newborn was colocated to the mother's breast as soon as possible, even if the mother was still in surgery. The mother's transfer to her room was with her baby skin to skin. The support staff was instructed not to separate the newborn until breast feeding occur for the first time or the mother required it.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Twenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section Receives: Procedure: Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section |
| Control group | No intervention | Twenty four pares of healthy mothers-newborns, with early clamping without skin-to-skin contact after birth by caesarean section and newborn attended in radiant warm table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of feeding to the exclusive maternal breast
Time in months when the newborn was fed to the exclusive maternal breast
Measured: six months or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study startJan 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- An intervention group compared to a similar historical group attended by the same group of doctors at an immediate previous time
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion Mexicana de Nacimiento Respetado, A.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farid Adán Pacheco Y Orozco, Asociacion Mexicana de Nacimiento Respetado, A.C.
- Investigators
- FARID ADAN PACHECO Y OROZCO, MD, Principal investigator, Asociación Mexicana del Nacimiento Respetado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052984
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2020
- First submitted
- 5 Aug 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All available data
Publications
Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
PubMed 17374818Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.
PubMed 28526223Vatansever B, Demirel G, Ciler Eren E, Erel O, Neselioglu S, Karavar HN, Gundogdu S, Ulfer G, Bahadir S, Tastekin A. Is early cord clamping, delayed cord clamping or cord milking best? J Matern Fetal Neonatal Med. 2018 Apr;31(7):877-880. doi: 10.1080/14767058.2017.1300647. Epub 2017 Mar 20.
PubMed 28320218Koopman I, Callaghan-Koru JA, Alaofin O, Argani CH, Farzin A. Early skin-to-skin contact for healthy full-term infants after vaginal and caesarean delivery: a qualitative study on clinician perspectives. J Clin Nurs. 2016 May;25(9-10):1367-76. doi: 10.1111/jocn.13227. Epub 2016 Mar 30.
PubMed 27027262Stevens 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 24720501Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Reprint). Pediatrics. 2015 Nov;136 Suppl 2:S196-218. doi: 10.1542/peds.2015-3373G. Epub 2015 Oct 14. No abstract available.
PubMed 26471383Kumar P, Yamada NK, Fuerch JH, Halamek LP. The neonatal resuscitation program: current recommendations and a look at the future. Indian J Pediatr. 2014 May;81(5):473-80. doi: 10.1007/s12098-013-1332-0. Epub 2014 Mar 22.
PubMed 24652267Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.
PubMed 28231274Brimdyr 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 29230957Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
PubMed 27885658World Health Organization Human Reproduction Programme, 10 April 2015. WHO Statement on caesarean section rates. Reprod Health Matters. 2015 May;23(45):149-50. doi: 10.1016/j.rhm.2015.07.007. Epub 2015 Jul 27. No abstract available.
PubMed 26278843Gomez Papi A, Baiges Nogues MT, Batiste Fernandez MT, Marca Gutierrez MM, Nieto Jurado A, Closa Monasterolo R. [Kangaroo method in delivery room for full-term babies]. An Esp Pediatr. 1998 Jun;48(6):631-3. Spanish.
PubMed 9662849Beake S, Bick D, Narracott C, Chang YS. Interventions for women who have a caesarean birth to increase uptake and duration of breastfeeding: A systematic review. Matern Child Nutr. 2017 Oct;13(4):e12390. doi: 10.1111/mcn.12390. Epub 2016 Nov 24.
PubMed 27882659Diaz-Castro J, Florido J, Kajarabille N, Garrido-Sanchez M, Padilla C, de Paco C, Navarrete L, Ochoa JJ. The timing of cord clamping and oxidative stress in term newborns. Pediatrics. 2014 Aug;134(2):257-64. doi: 10.1542/peds.2013-3798. Epub 2014 Jul 14.
PubMed 25022744Hooper SB, Binder-Heschl C, Polglase GR, Gill AW, Kluckow M, Wallace EM, Blank D, Te Pas AB. The timing of umbilical cord clamping at birth: physiological considerations. Matern Health Neonatol Perinatol. 2016 Jun 13;2:4. doi: 10.1186/s40748-016-0032-y. eCollection 2016.
PubMed 27298730
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cord Clamping and Early Skin-to-skin Contact in Cesarean Section as Interventions That Promote Exclusive Breastfeeding
- ClinicalTrials.gov ID
- NCT04052984
- Acronym / sponsor ID
- 1
- Conditions
- Breastfeeding, Exclusive
- Keywords
- Cesarean Section, Umbilical cord, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Asociacion Mexicana de Nacimiento Respetado, A.C.University, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 12 Aug 2019 (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.
Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits. However, in caesarean sections it is not common.
The investigators evaluate twenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section (intervention grup), compared to the same number of pairs attended by the same group of physicians under traditional techniques (control group). In both groups, morbidity and mortality as well as sole breastfeeding was evaluated for at least 6 months. The patients in the intervention group signed an informed consent form and the protocol was approved by an ethics committee.
Detailed description
BACKGROUND: Delayed umbilical cord clamping as well as immediate skin-to-skin contact between mother and newborn are emerging practices due to documented benefits for the mother-child binomial. The American Academy of Pediatrics, through the neonatal resuscitation program, considers that late clamping should be a common practice in all healthy babies, but in the case of a baby at risk, it recommends cutting the umbilical cord early and treating newborn on radiant warmer for resuscitation. Caesarean birth is considered a risk factor.
In Mexico and in many other countries early contact, skin to skin between the mother and child in Cesarean sections, is not common.
The World Health Organization (WHO), among multiple strategies to promote breastfeeding, promotes skin-to-skin contact at birth, that is: "to place babies with their mothers since birth minimal an hour or until the baby has been fed to the mother's breast". Different publications has determined that the ideal period to strengthen breastfeeding corresponds to the first minutes of life and does not go beyond the first 2 hours. Because it is usual to take care of the baby in radiant warmer, away from his mother, in caesarean sections, these recommendations are generally not met.
Searching the benefit of delayed cut of the umbilical cord, researchers began placing healthy babies in their mother's chest, even in cesarean deliveries, thus generating immediate skin-to-skin contact and incidentally an increase in the frequency of breastfeeding during the first six months, so a protocol was initiated to compare the morbidity and mortality of this technique in relation to traditional care (immediate cut of the umbilical cord and separation mother-child) and follow-up of babies at least six months to register the form of breastfeeding.
MATERIAL AND METHODS: Pilot study. All healthy mother-neonates binomials, obtained by caesarean section by the same medical team in 3 private hospitals, born between January 2015 and August 2017 in Villahermosa, Tabasco, Mexico followed for a minimum of 6 months in the private consultation were included. They were compared with an equal number of historical binomials, attended by the same medical team under the traditional technique and with the same follow-up time. The variables in this group were collected from their files.
By protocol of the medical group in both groups, it was encouraged to carry out an adequate program of exclusive breastfeeding, as marked by the World Health Organization consisting of starting breastfeeding in the first hour of life, that the Infant only received breast milk excluding other beverages such as water, teas or food, that breastfeeding was made on demand, as often as the child wanted both day and night and no bottles or pacifiers were used during his hospital stay.
The statistical evaluation included univariate analysis with frequencies and proportions for qualitative variables, measures of central tendency and dispersion for qualitative variables. In the bivariate analysis, X2 (or Fisher's Exact test) and Student's t (or Mann Whitney U) were used, as appropriate.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An intervention group compared to a similar historical group attended by the same group of doctors at an immediate previous time
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean sectionTwenty four pares of healthy mothers-newborns, with delayed clamping and immediate skin-to-skin contact after birth by caesarean section |
| Control group | No intervention | –Twenty four pares of healthy mothers-newborns, with early clamping without skin-to-skin contact after birth by caesarean section and newborn attended in radiant warm table |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Controlled pregnancies
- Pregnancies not complicated
- Single product
- Signed the informed consent to participate in the protocol
- Product obtained by caesarean section.
Key exclusion criteria (5 listed)
- Patients who did not wish to participate in the study
- Infants with prenatally suspected or diagnosticated congenital defects
- Multiple pregnancy
- Cases requesting to collect umbilical cord blood for storage in a cord cell bank
- Vaginal delivery
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 |
|---|---|---|
| Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean sectionMother: Placement of the insulating surgical arch was on the skin, between the abdomen and the thorax, electrocautery plate on the back, the gown superimposed, non-invasive blood pressure monitoring in legs and ear oximetry. The newborn was placed immediately on the mother's chest, passing it under the insulating arch and removing the mother's gown. Non-invasive monitoring was initiated with preductal pulse oximetry. The obstetrician cut the umbilical cord by not feeling the beats of the cord, or until 5 minutes. The newborn was reanimated without separating the baby from his mother. The temperature was taken with an infrared thermometer. Pulse oximetry was recorded. The newborn was colocated to the mother's breast as soon as possible, even if the mother was still in surgery. The mother's transfer to her room was with her baby skin to skin. The support staff was instructed not to separate the newborn until breast feeding occur for the first time or the mother required it. | Procedure or surgery | Intervention group |
Primary outcome
Duration of feeding to the exclusive maternal breast
Time frame: six months or more
Time in months when the newborn was fed to the exclusive maternal breast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 17374818Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
- Background: PubMed 28526223Katheria AC, Brown MK, Faksh A, Hassen KO, Rich W, Lazarus D, Steen J, Daneshmand SS, Finer NN. Delayed Cord Clamping in Newborns Born at Term at Risk for Resuscitation: A Feasibility Randomized Clinical Trial. J Pediatr. 2017 Aug;187:313-317.e1. doi: 10.1016/j.jpeds.2017.04.033. Epub 2017 May 16.
- Background: PubMed 28320218Vatansever B, Demirel G, Ciler Eren E, Erel O, Neselioglu S, Karavar HN, Gundogdu S, Ulfer G, Bahadir S, Tastekin A. Is early cord clamping, delayed cord clamping or cord milking best? J Matern Fetal Neonatal Med. 2018 Apr;31(7):877-880. doi: 10.1080/14767058.2017.1300647. Epub 2017 Mar 20.
- Background: PubMed 27027262Koopman I, Callaghan-Koru JA, Alaofin O, Argani CH, Farzin A. Early skin-to-skin contact for healthy full-term infants after vaginal and caesarean delivery: a qualitative study on clinician perspectives. J Clin Nurs. 2016 May;25(9-10):1367-76. doi: 10.1111/jocn.13227. Epub 2016 Mar 30.
- 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 26471383Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Reprint). Pediatrics. 2015 Nov;136 Suppl 2:S196-218. doi: 10.1542/peds.2015-3373G. Epub 2015 Oct 14. No abstract available.
- Background: PubMed 24652267Kumar P, Yamada NK, Fuerch JH, Halamek LP. The neonatal resuscitation program: current recommendations and a look at the future. Indian J Pediatr. 2014 May;81(5):473-80. doi: 10.1007/s12098-013-1332-0. Epub 2014 Mar 22.
- Background: PubMed 28231274Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.
- 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 27885658Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.
- Background: PubMed 26278843World Health Organization Human Reproduction Programme, 10 April 2015. WHO Statement on caesarean section rates. Reprod Health Matters. 2015 May;23(45):149-50. doi: 10.1016/j.rhm.2015.07.007. Epub 2015 Jul 27. No abstract available.
- Background: PubMed 9662849Gomez Papi A, Baiges Nogues MT, Batiste Fernandez MT, Marca Gutierrez MM, Nieto Jurado A, Closa Monasterolo R. [Kangaroo method in delivery room for full-term babies]. An Esp Pediatr. 1998 Jun;48(6):631-3. Spanish.
- Individual participant dataSharing planned: Yes. All available data
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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.
FARID ADAN PACHECO Y OROZCO, MD principal investigator
Asociación Mexicana del Nacimiento Respetado
Questions about this trial
What is this clinical trial studying?
A study testing Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section in people with Breastfeeding, Exclusive, run by Asociacion Mexicana de Nacimiento Respetado, A.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 13 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of feeding to the exclusive maternal breast (time frame: six months or more). 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 NCT04052984, which also lists 16 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 13 Jul 2020.