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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breastfeeding	Other: Skin to skin contact	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Quasi-experimental study
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Mother and Newborn Early Skin-to-skin Contact on Initiation of Breastfeeding, Newborn Temperature and Duration of Third Stage of Labor
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: May 30, 2017
• Actual Study Completion Date: May 30, 2017

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.

Outcome Measures

Primary Outcome Measures :

1. Early initiation of breastfeeding [ Time Frame: Immediately After birth ]
   Time to initiate breastfeeding
2. Third stage of labour [ Time Frame: birth ]
   Duration of third stage of labour
3. Newborn temperature [ Time Frame: 30 minutes after birth ]
   Newborn temperature 30 minutes after birth
4. Success of first breastfeeding [ Time Frame: Immediately after birth ]
   Success of first breastfeeding assessed by LATCH scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• healthy women with term singleton pregnancy

Exclusion Criteria:

• low APGAR score in Newborn

Contacts and Locations

Locations

Iraq

Kolsoom Safari

Erbil, Iraq, 44001

Sponsors and Collaborators

Hawler Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kolsoom Safari, Investigator, Hawler Medical University
• ClinicalTrials.gov Identifier: NCT03548389
• Other Study ID Numbers: 2
• First Posted: June 7, 2018
• Last Update Posted: June 8, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No