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

Sponsor

Bahar GÖBEL (Other)

Overall Status

Completed

CT.gov ID

NCT06011096

Collaborator

(none)

126

Enrollment

Location

Arms

9.2

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Comfort Postpartum Hemorrhage Midwifery Placenta	Other: skin-to-skin contact and delayed cord clamping Other: avoiding skin-to-skin contact and early cord clamping	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Health Services Research

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

Actual Study Start Date :

Nov 2, 2022

Actual Primary Completion Date :

Jun 10, 2023

Actual Study Completion Date :

Aug 9, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Skin-to-skin contact and delayed cord clamping affect placental separation time. [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.
Skin-to-skin contact and delayed cord clamping affect the amount of postpartum bleeding. [0-6 hours]
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. [0-30 minute]
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. [2 hours]
Increasing the postpartum comfort level of women who had vaginal delivery with skin-to-skin contact and delayed cord clamping.