NCT04425096

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

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

May 25, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

June 4, 2020

Last Update Submit

December 2, 2021

Conditions

Keywords

Postpartum PainBreastfeedingBeta EndorphinOxytocinPostpartum HemorrhageSkin to Skin Contact

Outcome Measures

Primary Outcomes (7)

  • Oxytocin Analysis

    Oxytocin 1minute level

    1 minute -30 minutes.

  • ᵦ endorphin Analysis

    ᵦ endorphin 1 minute

    1 minute -30 minutes.

  • 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

    2nd hour- 6 th hour

  • 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.

    24th hour -1st week

  • 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.

    24th hour -1st week

  • 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.

    24th hour

  • 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.

    24th hour

Study Arms (2)

Skin to skin contact

EXPERIMENTAL

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

Other: Skin to skin contact

Routine care

NO INTERVENTION

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

Interventions

Skin to skin contact

Skin to skin contact

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglık Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

  • 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

    BACKGROUND
  • Annagür, B. & Annagür, A. (2012). Relationship of Postpartum Mental Status with Breastfeeding. Current Approaches in Psychiatry, 4, 279-292

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 25988992BACKGROUND
  • 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.

    PMID: 28683833BACKGROUND
  • Edwards HM. Aetiology and treatment of severe postpartum haemorrhage. Dan Med J. 2018 Mar;65(3):B5444.

    PMID: 29510809BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26682656BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26969615BACKGROUND

MeSH Terms

Conditions

Breast FeedingPostpartum Hemorrhage

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yasemin AYDIN KARTAL, PhD

    Saglık Bilimleri U

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled single-blind experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

May 25, 2020

Primary Completion

September 25, 2020

Study Completion

December 22, 2020

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations