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

August 23, 2023 updated by: Bahar GÖBEL

The Effect of Skin-to-Skin Contact and Delayed Cord Clampingon Placental Separation Time, Separation Method, Amount of Postpartum Bleeding and Postpartum Comfort

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

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
      • Erzurum, Turkey
        • Erzurum City Hospital

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • for pregnant women

    1. Those who agreed to participate in the research
    2. 18-49 years old
    3. Firstborn (nulliparous)
    4. Have 37-42 weeks of pregnancy
    5. The baby in head presentation
    6. No prenatal risk pregnancy
    7. No risk during and after birth

  • for newborns

    1. Absence of any health problems or congenital diseases,
    2. No need for resuscitation after birth.
    3. APGAR score of 8 points or more

Exclusion Criteria:

  1. Births less than 37 weeks
  2. Multiparity
  3. Any complications in the mother or baby
  4. Removal of the placenta by intervention rather than spontaneous separation

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the group with skin-to-skin contact and delayed cord clamping
In this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby.
Other: skin-to-skin contact and delayed cord clamping
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.
Experimental: The group without skin-to-skin contact and early cord clamping
In this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby.
Other: avoiding skin-to-skin contact and early cord clamping
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin-to-skin contact and delayed cord clamping affect placental separation time.
Time Frame: 0-30 minute
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.
0-30 minute
Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding.
Time Frame: 0-6 hours
Skin-to-skin contact and delayed cord clamping reduce the amount of postpartum hemorrhage in women who deliver vaginally.
0-6 hours
Skin-to-skin contact and delayed cord clamping have no effect on the type of placental separation.
Time Frame: 0-30 minute
Determination of the effect of skin-to-skin contact and delayed cord clamping on the type of placental separation.
0-30 minute
Skin-to-skin contact and delayed cord clamping affect the level of postpartum comfort.
Time Frame: 2 hours
Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.
2 hours

Collaborators and Investigators

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

Sponsor

Bahar GÖBEL

Investigators

  • Principal Investigator: Bahar Göbel, Midwife

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)

November 2, 2022

Primary Completion (Actual)

June 10, 2023

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erzurum Atatürk Üniversitesi

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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