CClinicalTrials.gg
CompletedNCT06011096Updated Aug 25, 2023

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

An interventional study of skin-to-skin contact and delayed cord clamping and avoiding skin-to-skin contact and early cord clamping in Patient Comfort, Postpartum Hemorrhage and Midwifery, sponsored by Bahar GÖBEL. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Bahar GÖBEL · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherskin-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.

  • Otheravoiding 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-30 minute

  2. 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.

    Time frame: 0-6 hours

  3. 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.

    Time frame: 0-30 minute

  4. 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.

    Time frame: 2 hours

06

Study locations

1 site
  • Erzurum City Hospital
    Erzurum, Turkey
07

Registry details

Key details

Study ID
NCT06011096
Lead sponsor
Bahar GÖBEL
Responsible party
Bahar GÖBEL (Midwife, Ataturk University) — Sponsor-investigator
First posted
Aug 25, 2023
Start date
Nov 2, 2022
Primary completion
Jun 10, 2023
Completion
Aug 9, 2023
Last update
Aug 25, 2023

Study contacts

Bahar Göbel
principal investigator · Midwife

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion