BreastfeedingNCT03548389
The Effect of Early Skin-to-skin Contact on Initiation of Breastfeeding, Newborn Temperature and Duration of Third Stage of Labor
A study testing Skin to skin contact in people with Breastfeeding, run by Hawler Medical University at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Skin to skin contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2017to 30 May 2017
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women with term singleton pregnancy
Who cannot join
- low APGAR score in Newborn
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Breastfeeding
- Being tested
- Skin to skin contact
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin to skin contactOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early initiation of breastfeeding
Time to initiate breastfeeding
Measured: Immediately After birth
Third stage of labour
Duration of third stage of labour
Measured: birth
Newborn temperature
Newborn temperature 30 minutes after birth
Measured: 30 minutes after birth
Success of first breastfeeding
Success of first breastfeeding assessed by LATCH scale
Measured: Immediately after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Feb 2017
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kolsoom Safari, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548389
- Sponsor's protocol ID
- 2
- Status last verified
- Jun 2018
- First submitted
- 23 May 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I would make IPD available if any researcher required them , since I I save my participants information by coding.
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.
PubMed 30026787
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03548389
- Acronym / sponsor ID
- 2
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 7 Jun 2018 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Mother and newborn skin to skin contact | Experimental | Other: Skin to skin contactBy 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. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women with term singleton pregnancy
Key exclusion criteria (1 listed)
- low APGAR score in Newborn
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 |
|---|---|---|
| Skin to skin contactBy 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 | Mother and newborn skin to skin contact |
Primary outcome
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
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 8 Jun 2018.
- Derived from this study: PubMed 30026787Safari 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.
- Individual participant dataSharing planned: Undecided. I would make IPD available if any researcher required them , since I I save my participants information by coding.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin to skin contact in people with Breastfeeding, run by Hawler Medical University at 1 site in Iraq.
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 1 inclusion and 1 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early initiation of breastfeeding (time frame: Immediately After birth). The study lists 4 primary outcomes in all. 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 NCT03548389, which also lists 1 linked publication.
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 8 Jun 2018.