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The Effect of Early Skin-to-skin Contact on Initiation of Breastfeeding, Newborn Temperature and Duration of Third Stage of Labor

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ClinicalTrials.gov Identifier: NCT03548389
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kolsoom Safari, Hawler Medical University

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • Early initiation of breastfeeding [ Time Frame: Immediately After birth ]
    Time to initiate breastfeeding
  • Third stage of labour [ Time Frame: birth ]
    Duration of third stage of labour
  • Newborn temperature [ Time Frame: 30 minutes after birth ]
    Newborn temperature 30 minutes after birth
  • Success of first breastfeeding [ Time Frame: Immediately after birth ]
    Success of first breastfeeding assessed by LATCH scale
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Early initiation of breastfeeding [ Time Frame: Immediately After birth ]
    Time to initiate breastfeeding
  • Third stage of labour [ Time Frame: birth ]
    Duration of third stage of labour
  • Newborn temperature [ Time Frame: 30 minutes after birth ]
    Newborn temperature 30 minutes after birth
  • Success of first breastfeeding [ Time Frame: Immidiately after birth ]
    Success of first breastfeeding assessed by LATCH scale
Change History Complete list of historical versions of study NCT03548389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Early Skin-to-skin Contact on Initiation of Breastfeeding, Newborn Temperature and Duration of Third Stage of Labor
Official Title  ICMJE The Effect of Mother and Newborn Early Skin-to-skin Contact on Initiation of Breastfeeding, Newborn Temperature and Duration of Third Stage of Labor
Brief Summary

Background: Keeping mother and newborn skin-to-skin contact (SSC) after birth brings about numerous protective effects; however, it is an intervention that is underutilized in Iraq where a globally considerable rate of maternal and child death has been reported. The present study was carried out in order to assess the effects of mother and newborn skin-to-skin contact on initiation of breastfeeding, newborn temperature, and duration of the third stage of labor.

Methods: A quasi-experimental study was conducted on 108 healthy women and their neonates (56 in the intervention group with mother and newborn skin-to-skin contact and 52 in the control group that were provided with routine postpartum care) at maternity teaching hospital of Erbil, Iraq from February to May, 2017. The required data were collected using four instruments. The first instrument was a structured interview to elicit socio-demographic and obstetric characteristics from the participants. The second instrument was a form that was used to assess the duration of the third stage of labor in mothers. The third instrument was a form to record the newborns' axillary temperature. The fourth instrument was the LATCH scale that was employed to assess the success of the first breastfeed.Descriptive relationships between demographic variables and type of care provided for mothers and newborns after birth were explored using means and SD for continuous variables, whilst categorical variables were described using proportions. The relationship between SSC and time to initiate breastfeeding, duration of third stage of labour, success of breastfeeding, newborn hypothermia, and temperature of the newborn 30 minutes after birth were examined using T test and Chi square. In logistic regression model, the effect of SSC and conventional care on outcomes of the study was analysed by adjusting of potential confounders like mother's age, education level, occupation, number of parity, and newborn gender.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Quasi-experimental study
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Breastfeeding
Intervention  ICMJE Other: Skin to skin contact
By assistance of the researcher, intervention infants were placed undressed in a prone position against their mothers' bare chest between breasts immediately after birth and before placental delivery and suturing of tears or episiotomy. The Apgar score was determined, the infant's nose and mouth were suctioned while on the mother's chest, it was well dried, and both mother and infant were covered with a pre-warmed blanket. To prevent heat loss, the infant's head was covered with a dry cap that was replaced when it became damp. Dressing and measuring of the infant were postponed to an hour after the delivery by registered midwife.
Study Arms  ICMJE
  • Experimental: Mother and newborn skin to skin contact
    By assistance of the researcher, intervention infants were placed undressed in a prone position against their mothers' bare chest between breasts immediately after birth and before placental delivery and suturing of tears or episiotomy. The Apgar score was determined, the infant's nose and mouth were suctioned while on the mother's chest, it was well dried, and both mother and infant were covered with a pre-warmed blanket. To prevent heat loss, the infant's head was covered with a dry cap that was replaced when it became damp. Dressing and measuring of the infant were postponed to an hour after the delivery by registered midwife.
    Intervention: Other: Skin to skin contact
  • No Intervention: Conventional care
    In the routine care group, the infant was delivered from the mother by a midwife, wrapped in blankets, taken to be routinely cared under a warmer, and then dried quickly. Afterwards, the Apgar score was determined immediately after the umbilical cord was cut. The infants were provided with all routine care by the midwife working in the delivery room. After the infants were weighed, dressed, and measured, they were handed to their mothers who were encouraged to begin breastfeeding.
Publications * Safari K, Saeed AA, Hasan SS, Moghaddam-Banaem L. The effect of mother and newborn early skin-to-skin contact on initiation of breastfeeding, newborn temperature and duration of third stage of labor. Int Breastfeed J. 2018 Jul 16;13:32. doi: 10.1186/s13006-018-0174-9. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
108
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 30, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy women with term singleton pregnancy

Exclusion Criteria:

  • low APGAR score in Newborn
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iraq
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548389
Other Study ID Numbers  ICMJE 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: I would make IPD available if any researcher required them , since I I save my participants information by coding.
Responsible Party Kolsoom Safari, Hawler Medical University
Study Sponsor  ICMJE Hawler Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hawler Medical University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP