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

NCT ID: NCT06011096

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2023-08-09

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.

Conditions

Patient Comfort; Postpartum Hemorrhage; Midwifery; Placenta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

skin-to-skin contact and delayed cord clamping

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

avoiding skin-to-skin contact and early cord clamping

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bahar GÖBEL

OTHER

Sponsor Role: lead

Responsible Party

Bahar GÖBEL

Midwife

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bahar Göbel

Role: PRINCIPAL_INVESTIGATOR

Midwife

Locations

Erzurum City Hospital

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Erzurum Atatürk Üniversitesi

Identifier Type: -

Identifier Source: org_study_id