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The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding

Primary Purpose

Skin to Skin Contact

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Skin to skin contact
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin to Skin Contact focused on measuring Postpartum Pain, Breastfeeding, Beta Endorphin, Oxytocin, Postpartum Hemorrhage, Skin to Skin Contact

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women aged 18-35 years,
  • having a single pregnancy,
  • literate,
  • between 37-42 gestational week,
  • hemoglobin level of 10 g and above,
  • without chronic, mental and psychological disease

Infants;

  • without congenital anomalies,
  • with a first Apgar score of 8 and above,
  • birth weight between 2500 - 4000 g
  • no obstruction to oral feeding

Exclusion Criteria:

  • Induction practice,
  • multiparity,
  • any risky condition development in the mother and baby during or after birth

Sites / Locations

  • Saglık Bilimleri Universitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Skin to skin contact

Routine care

Arm Description

The mothers and their babies in the experimental group received a 30-minute skin to skin contact immediately after birth (n:34)

The babies in the control group received routine care (n:34)

Outcomes

Primary Outcome Measures

Oxytocin Analysis
Oxytocin 1minute level
ᵦ endorphin Analysis
ᵦ endorphin 1 minute
VAS (Visuel Analog Scale)
VAS is a commonly used measurement tool for determining the degree of pain. The patient is asked to mark his or her pain on a 10 cm ruler that writes painlessness (0) on one end and the most severe pain (10) on the other end
LATCH Breastfeeding Assessment Tool
LATCH (L: is for how well the infantlatches onto the breast, A: is for the amount of audibleswallowing noted, T: is for the mother's nipple type/condition, C: is for the mother's level of comfort, and H: isfor the amount of help the mother needs to hold her infant tothe breast) assessment tool is based on observations and descriptions of effective breastfeeding, evaluates five characteristics of breastfeeding .The total score ranges from 0 to 10, with the higherscore representing successful breastfeeding.
Breastfeeding Self-Efficacy Scale
Breastfeeding Self-Efficacy Scale; The 5-point Likert type scale consists of 14 items. Minimum 14 points, maximum 70 points can be obtained, and high scores indicate that breastfeeding selfefficacy is higher.
Postpartum Blood Bag
Immediately after birth, a postpartum hemorrhage follow-up bag was placed on the gynecological table and followed by a bleeding bag until the mother got up from the gynecological table.
Total Postpartum Blood Loss
Total Postpartum Blood Loss(postpartum blood bag +pad test ): Immediately after birth, a postpartum hemorrhage follow-up bag was placed on the gynecological table and followed by a bleeding bag until the mother got up from the gynecological table. When women were taken to bed from gynecological table, bleeding was followed up with a perineal pad. Weights of pad and mattress protections of women were weighed at 24 hours because normal women were discharged at 24 hours after delivery.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2020
Last Updated
December 2, 2021
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT04425096
Brief Title
The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding
Official Title
The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study was to determine the effect of postpartum hemorrhage, pain and onset of early breastfeeding so that the skin applied at the third stage of birth is in contact with the skin. Material and Method: The study was carried out as a randomized controlled single-blind experimental study. The sample consists of 68 healthy mother and baby pairs. Skin contact with mothers and babies in the experimental group will be applied for 34 minutes immediately after birth. Routine care will be applied to the babies in the control group. Data will be collected using Personal Information Form, Visual Analogue Scale, LATCH Breastfeeding Diagnostic Scale, Breastfeeding Self-Efficacy Scale, postpartum hemorrhage follow-up bag, pad and oxytocin, ᵦ endorphine analysis results. were collected using Personal Information Form, Visual Analogue Scale, LATCH Breastfeeding Diagnostic Scale, Breastfeeding Self-Efficacy Scale, postpartum bleeding follow-up bag, pad and oxytocin, ᵦ endorphin analysis results.
Detailed Description
Implementation of the Practice of the Study; In the standard practice of the delivery room clinic, where the study was planned, babies are clamped as soon as they are born, and their routine care (such as K vit and hepatitis B vaccine application) is taken under the radiant heater. The skin contact can not be applied between the baby and the mother. After the baby is cared, until the mother is transferred to the postpartum clinic, the baby is wrapped in a clean cotton sterile cloth under a radiant heater in the baby room. Routine care was applied to the babies of the control group mothers. No physical contact with the babies of the control group mothers was performed, standard applications were applied in the clinic (placing the baby under the radiant heater for clamping the umbilical cord as soon as it was born, K-vit application, Hepatitis B vaccine application etc.). As soon as the babies of the mothers in the experimental group were born, the babies were placed in a prone position with skin contact on their mothers' bare belly. The baby was gently dried, covered with a blanket and a beret was worn. The umbilical cord of the baby was clamped late (approximately 1-3 minutes). The baby was kept in this position for 30 minutes and then taken under the radiant heater for routine care. Blood was collected from women in the experimental and control groups for the 1st and 30th minutes after the birth of the baby for oxytocin and ᵦ endorphin analysis. After for both groups, VAS was applied after 2nd and 6th hours after birth, LATCH Breastfeeding Assessment and BSS were applied in 24th hour and 1 week later of the birth. Immediately after birth, a postpartum hemorrhage follow-up bag was placed on the gynecological table and followed by a bleeding bag until the mother got up from the gynecological table. When women were taken to bed from gynecological table, bleeding was followed up with a perineal pad. Weights of pad and mattress protections of women were weighed at 24 hours because normal women were discharged at 24 hours after delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin to Skin Contact
Keywords
Postpartum Pain, Breastfeeding, Beta Endorphin, Oxytocin, Postpartum Hemorrhage, Skin to Skin Contact

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled single-blind experimental study.
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin to skin contact
Arm Type
Experimental
Arm Description
The mothers and their babies in the experimental group received a 30-minute skin to skin contact immediately after birth (n:34)
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
The babies in the control group received routine care (n:34)
Intervention Type
Other
Intervention Name(s)
Skin to skin contact
Intervention Description
Skin to skin contact
Primary Outcome Measure Information:
Title
Oxytocin Analysis
Description
Oxytocin 1minute level
Time Frame
1 minute -30 minutes.
Title
ᵦ endorphin Analysis
Description
ᵦ endorphin 1 minute
Time Frame
1 minute -30 minutes.
Title
VAS (Visuel Analog Scale)
Description
VAS is a commonly used measurement tool for determining the degree of pain. The patient is asked to mark his or her pain on a 10 cm ruler that writes painlessness (0) on one end and the most severe pain (10) on the other end
Time Frame
2nd hour- 6 th hour
Title
LATCH Breastfeeding Assessment Tool
Description
LATCH (L: is for how well the infantlatches onto the breast, A: is for the amount of audibleswallowing noted, T: is for the mother's nipple type/condition, C: is for the mother's level of comfort, and H: isfor the amount of help the mother needs to hold her infant tothe breast) assessment tool is based on observations and descriptions of effective breastfeeding, evaluates five characteristics of breastfeeding .The total score ranges from 0 to 10, with the higherscore representing successful breastfeeding.
Time Frame
24th hour -1st week
Title
Breastfeeding Self-Efficacy Scale
Description
Breastfeeding Self-Efficacy Scale; The 5-point Likert type scale consists of 14 items. Minimum 14 points, maximum 70 points can be obtained, and high scores indicate that breastfeeding selfefficacy is higher.
Time Frame
24th hour -1st week
Title
Postpartum Blood Bag
Description
Immediately after birth, a postpartum hemorrhage follow-up bag was placed on the gynecological table and followed by a bleeding bag until the mother got up from the gynecological table.
Time Frame
24th hour
Title
Total Postpartum Blood Loss
Description
Total Postpartum Blood Loss(postpartum blood bag +pad test ): Immediately after birth, a postpartum hemorrhage follow-up bag was placed on the gynecological table and followed by a bleeding bag until the mother got up from the gynecological table. When women were taken to bed from gynecological table, bleeding was followed up with a perineal pad. Weights of pad and mattress protections of women were weighed at 24 hours because normal women were discharged at 24 hours after delivery.
Time Frame
24th hour

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 18-35 years, having a single pregnancy, literate, between 37-42 gestational week, hemoglobin level of 10 g and above, without chronic, mental and psychological disease Infants; without congenital anomalies, with a first Apgar score of 8 and above, birth weight between 2500 - 4000 g no obstruction to oral feeding Exclusion Criteria: Induction practice, multiparity, any risky condition development in the mother and baby during or after birth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasemin AYDIN KARTAL, PhD
Organizational Affiliation
Saglık Bilimleri U
Official's Role
Study Director
Facility Information:
Facility Name
Saglık Bilimleri Universitesi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Alus Tokat, M. & Okumuş, H. (2013). The Effect of Antenatal Training Based on Strengthening the Perception of Breastfeeding Self-Efficacy on the Perception of Breastfeeding Self- Efficacy and Breastfeeding. Journal of Nursing Education and Research, 10, 21-29
Results Reference
background
Citation
Annagür, B. & Annagür, A. (2012). Relationship of Postpartum Mental Status with Breastfeeding. Current Approaches in Psychiatry, 4, 279-292
Results Reference
background
Citation
Çalısır, H., Karaçam, Z., Akgül, F.A. & Kurnaz, D.A. (2009). Validity and Reliability of the Turkish Form of the Postpartum Parenting Behavior Scale. Journal of Atatürk University School of Nursing, 12, 1-8
Results Reference
background
PubMed Identifier
25988992
Citation
Cong X, Ludington-Hoe SM, Hussain N, Cusson RM, Walsh S, Vazquez V, Briere CE, Vittner D. Parental oxytocin responses during skin-to-skin contact in pre-term infants. Early Hum Dev. 2015 Jul;91(7):401-6. doi: 10.1016/j.earlhumdev.2015.04.012. Epub 2015 May 16.
Results Reference
background
PubMed Identifier
28683833
Citation
Cooijmans KHM, Beijers R, Rovers AC, de Weerth C. Effectiveness of skin-to-skin contact versus care-as-usual in mothers and their full-term infants: study protocol for a parallel-group randomized controlled trial. BMC Pediatr. 2017 Jul 6;17(1):154. doi: 10.1186/s12887-017-0906-9.
Results Reference
background
PubMed Identifier
29510809
Citation
Edwards HM. Aetiology and treatment of severe postpartum haemorrhage. Dan Med J. 2018 Mar;65(3):B5444.
Results Reference
background
Citation
Essa R.M., İsmail N. & İsmail A. (2015). Effect of Early Maternal/Newborn Skin-To- Skin Contact After Birth On The Duration Of Third Stage Of Labor And İnitiation Of Breastfeeding. Journal of Nursing Education and Practice, 54, 98-107.
Results Reference
background
PubMed Identifier
26682656
Citation
Hughes KN, Rodriguez-Carter J, Hill J, Miller D, Gomez C. Using Skin-to-Skin Contact to Increase Exclusive Breastfeeding at a Military Medical Center. Nurs Womens Health. 2015 Dec-2016 Jan;19(6):478-89. doi: 10.1111/1751-486X.12244.
Results Reference
background
Citation
Karimi, A., Tara, F., Khadivzadeh, T. & Aghamohammadian, Sharbaf, H.R. (2013). The Effect of Skin to Skin Contact Immediately after Delivery on the Maternal Attachment and Anxiety Regarding Infant. Iran J Obstet Gynecol Infertil, 16, 7-15.
Results Reference
background
Citation
Karimi, F.Z., Bagheri, S., Tara, F., Khadivzadeh, T. & Mousavi, Bazaz, S.M. (2014). Effect ofKangaroo Mother Care on breastfeeding self efficacy in primiparous women, 3 month after child birth. Iran J Obstet Gynecol Infertil, 17, 1-8.
Results Reference
background
PubMed Identifier
26969615
Citation
Linares AM, Wambach K, Rayens MK, Wiggins A, Coleman E, Dignan MB. Modeling the Influence of Early Skin-to-Skin Contact on Exclusive Breastfeeding in a Sample of Hispanic Immigrant Women. J Immigr Minor Health. 2017 Oct;19(5):1027-1034. doi: 10.1007/s10903-016-0380-8.
Results Reference
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The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding

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