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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03548389
Other study ID # 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date May 30, 2017

Study information

Verified date June 2018
Source Hawler Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date May 30, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- healthy women with term singleton pregnancy

Exclusion Criteria:

- low APGAR score in Newborn

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Iraq Kolsoom Safari Erbil

Sponsors (1)

Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early initiation of breastfeeding Time to initiate breastfeeding Immediately After birth
Primary Third stage of labour Duration of third stage of labour birth
Primary Newborn temperature Newborn temperature 30 minutes after birth 30 minutes after birth
Primary Success of first breastfeeding Success of first breastfeeding assessed by LATCH scale Immediately after birth
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