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

December 2, 2021 updated by: YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi

The Effect of Skin to Skin Contact on Postpartum Hemorrhage, Pain And Breastfeeding: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Sağlık Bilimleri Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Skin to skin contact
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
Skin to skin contact
NO_INTERVENTION: Routine care
The babies in the control group received routine care (n:34)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxytocin Analysis
Time Frame: 1 minute -30 minutes.
Oxytocin 1minute level
1 minute -30 minutes.
ᵦ endorphin Analysis
Time Frame: 1 minute -30 minutes.
ᵦ endorphin 1 minute
1 minute -30 minutes.
VAS (Visuel Analog Scale)
Time Frame: 2nd hour- 6 th hour
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
Time Frame: 24th hour -1st week
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
Time Frame: 24th hour -1st week
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
Time Frame: 24th hour
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
Time Frame: 24th hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Study Director: Yasemin AYDIN KARTAL, PhD, Saglık Bilimleri U

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 25, 2020

Primary Completion (ACTUAL)

September 25, 2020

Study Completion (ACTUAL)

December 22, 2020

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (ACTUAL)

June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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