NCT03548389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

May 23, 2018

Last Update Submit

June 6, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Early initiation of breastfeeding

    Time to initiate breastfeeding

    Immediately After birth

  • Third stage of labour

    Duration of third stage of labour

    birth

  • Newborn temperature

    Newborn temperature 30 minutes after birth

    30 minutes after birth

  • Success of first breastfeeding

    Success of first breastfeeding assessed by LATCH scale

    Immediately after birth

Study Arms (2)

Mother and newborn skin to skin contact

EXPERIMENTAL

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

Conventional care

NO INTERVENTION

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.

Interventions

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.

Mother and newborn skin to skin contact

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women with term singleton pregnancy

You may not qualify if:

  • low APGAR score in Newborn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kolsoom Safari

Erbil, 44001, Iraq

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 7, 2018

Study Start

February 1, 2017

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations