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The Effect of Skin-to-skin Contact on Placental Separation Time, Type, Postpartum Hemorrhage and Comfort

Primary Purpose

Patient Comfort, Postpartum Hemorrhage, Midwifery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
skin-to-skin contact and delayed cord clamping
avoiding skin-to-skin contact and early cord clamping
Sponsored by
Bahar GÖBEL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Comfort focused on measuring skin-to-skin contact, placental separation time, Postpartum Comfort, placental separation method, delayed clamping of the umbilical cord, midwife

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: for pregnant women Those who agreed to participate in the research 18-49 years old Firstborn (nulliparous) Have 37-42 weeks of pregnancy The baby in head presentation No prenatal risk pregnancy No risk during and after birth for newborns Absence of any health problems or congenital diseases, No need for resuscitation after birth. APGAR score of 8 points or more Exclusion Criteria: Births less than 37 weeks Multiparity Any complications in the mother or baby Removal of the placenta by intervention rather than spontaneous separation

Sites / Locations

  • Erzurum City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

the group with skin-to-skin contact and delayed cord clamping

The group without skin-to-skin contact and early cord clamping

Arm Description

In this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby.

In this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby.

Outcomes

Primary Outcome Measures

Skin-to-skin contact and delayed cord clamping affect placental separation time.
It shortens the placental separation time in women who have had a vaginal delivery with skin-to-skin contact and delayed clamping of the cord.
Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding.
Skin-to-skin contact and delayed cord clamping reduce the amount of postpartum hemorrhage in women who deliver vaginally.
Skin-to-skin contact and delayed cord clamping have no effect on the type of placental separation.
Determination of the effect of skin-to-skin contact and delayed cord clamping on the type of placental separation.
Skin-to-skin contact and delayed cord clamping affect the level of postpartum comfort.
Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 23, 2023
Sponsor
Bahar GÖBEL
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1. Study Identification

Unique Protocol Identification Number
NCT06011096
Brief Title
The Effect of Skin-to-skin Contact on Placental Separation Time, Type, Postpartum Hemorrhage and Comfort
Official Title
The Effect of Skin-to-Skin Contact and Delayed Cord Clampingon Placental Separation Time, Separation Method, Amount of Postpartum Bleeding and Postpartum Comfort
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
June 10, 2023 (Actual)
Study Completion Date
August 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bahar GÖBEL

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
It is aimed to determine the late cord clamping with early skin-to-skin contact in primiparous pregnant women who delivered vaginally, according to placental separation time, separation method, amount of postpartum bleeding and postpartum comfort.
Detailed Description
The research is an experimental type randomized controlled trial. The data of the research gathered in the delivery room clinic of Erzurum City Hospital affiliated to the Ministry of Health in Erzurum city center between 02.11.2022 and 10.06.2023. The study was completed with 126 primiparous pregnants, 63 of whom were controls and 63 of whom were experimental, randomized in the clinic. "Personal Information Form" and "Postpartum Comfort Scale" prepared by the researcher were used to collect the data of the study. control group Pregnant women who met the criteria for admission to the delivery room were selected, the institution's routine policies were implemented. The mother was informed about the study and written consent was obtained. Hospital routine practices continued until birth. The stopwatch is started the moment the baby is born. After birth, the umbilical cord was clamped immediately without skin-to-skin contact between the mother and the baby, and the baby was taken to routine care. Signs of placental separation were monitored with a stopwatch, and it was noted at what minute the symptoms were seen. Placental delivery time and separation type were noted in the relevant part of the form. According to the routines taken from each hospitalized patient in institutional policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form. The Personal Information Form consisting of 22 questions and the Postpartum Comfort scale were administered to the mother at the end of the follow-up period in the delivery room (2 hours later). From the 6th hour blood values found in the hospital routine, the mother's hemoglobin and hematocrit values were noted on the form. Experimental group Pregnant women who met the criteria for admission to the delivery room were selected, the institution's routine policies were implemented. The mother was informed about the study and written consent was obtained. Hospital routine practices continued until birth. The stopwatch is started the moment the baby is born. The baby was placed on the mother's chest, it was waited for 60-90 seconds in skin-to-skin contact, and breastfeeding was tried. At the end of the period, the umbilical cord was clamped and the baby was placed under a radiant heater and routine care was continued. Signs of placental separation were monitored with a stopwatch, and it was noted at what minute the symptoms were seen. Placental delivery time and separation type were noted in the relevant part of the form. According to the routines taken from each hospitalized patient in institutional policies, the volunteer's entry hemoglobin and hematocrit values were noted on the form. During the repair of episiotomy or desuria, if any, in the mother, skin-to-skin contact was made between the baby and the mother for 1 hour without disrupting the procedures. The Personal Information Form consisting of 22 questions and the Postpartum Comfort scale were administered to the mother at the end of the follow-up period in the delivery room (2 hours later). From the 6th hour blood values found in the hospital routine, the mother's hemoglobin and hematocrit values were noted on the form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Comfort, Postpartum Hemorrhage, Midwifery, Placenta
Keywords
skin-to-skin contact, placental separation time, Postpartum Comfort, placental separation method, delayed clamping of the umbilical cord, midwife

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the group with skin-to-skin contact and delayed cord clamping
Arm Type
Experimental
Arm Description
In this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby.
Arm Title
The group without skin-to-skin contact and early cord clamping
Arm Type
Experimental
Arm Description
In this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby.
Intervention Type
Other
Intervention Name(s)
skin-to-skin contact and delayed cord clamping
Intervention Description
Placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated with skin-to-skin contact and late cord clamping after delivery.
Intervention Type
Other
Intervention Name(s)
avoiding skin-to-skin contact and early cord clamping
Intervention Description
After delivery, placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated without skin-to-skin contact and late cord clamping.
Primary Outcome Measure Information:
Title
Skin-to-skin contact and delayed cord clamping affect placental separation time.
Description
It shortens the placental separation time in women who have had a vaginal delivery with skin-to-skin contact and delayed clamping of the cord.
Time Frame
0-30 minute
Title
Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding.
Description
Skin-to-skin contact and delayed cord clamping reduce the amount of postpartum hemorrhage in women who deliver vaginally.
Time Frame
0-6 hours
Title
Skin-to-skin contact and delayed cord clamping have no effect on the type of placental separation.
Description
Determination of the effect of skin-to-skin contact and delayed cord clamping on the type of placental separation.
Time Frame
0-30 minute
Title
Skin-to-skin contact and delayed cord clamping affect the level of postpartum comfort.
Description
Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.
Time Frame
2 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
primiparous women giving birth vaginally
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: for pregnant women Those who agreed to participate in the research 18-49 years old Firstborn (nulliparous) Have 37-42 weeks of pregnancy The baby in head presentation No prenatal risk pregnancy No risk during and after birth for newborns Absence of any health problems or congenital diseases, No need for resuscitation after birth. APGAR score of 8 points or more Exclusion Criteria: Births less than 37 weeks Multiparity Any complications in the mother or baby Removal of the placenta by intervention rather than spontaneous separation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahar Göbel
Organizational Affiliation
Midwife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erzurum City Hospital
City
Erzurum
Country
Turkey

12. IPD Sharing Statement

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The Effect of Skin-to-skin Contact on Placental Separation Time, Type, Postpartum Hemorrhage and Comfort

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