Patient ComfortNCT06011096
The Effect of Skin-to-skin Contact on Placental Separation Time, Type, Postpartum Hemorrhage and Comfort
A study testing skin-to-skin contact and delayed cord clamping and avoiding skin-to-skin contact and early cord clamping in people with Patient Comfort and Postpartum Hemorrhage, run by Bahar GÖBEL at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Comfort, Postpartum Hemorrhage, Midwifery
- What is being tested?
- skin-to-skin contact and delayed cord clamping and avoiding skin-to-skin contact and early cord clamping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2022to 9 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Births less than 37 weeks
- Multiparity
- Any complications in the mother or baby
- Removal of the placenta by intervention rather than spontaneous separation
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Patient Comfort, Postpartum Hemorrhage, Midwifery, Placenta
- Being tested
- skin-to-skin contact and delayed cord clamping, avoiding skin-to-skin contact and early cord clamping
- Keywords
- skin-to-skin contact, placental separation time, Postpartum Comfort, placental separation method, delayed clamping of the umbilical cord, midwife
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skin contact and delayed cord clampingOther
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.
avoiding skin-to-skin contact and early cord clampingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| the group with skin-to-skin contact and delayed cord clamping | Experimental | In this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby. Receives: Other: skin-to-skin contact and delayed cord clamping |
| The group without skin-to-skin contact and early cord clamping | Experimental | In this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby. Receives: Other: avoiding skin-to-skin contact and early cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-30 minute
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.
Measured: 0-6 hours
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.
Measured: 0-30 minute
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start2 Nov 2022
- Primary completion10 Jun 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahar GÖBEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahar GÖBEL, Ataturk University
- Investigators
- Bahar Göbel, Principal investigator, Midwife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011096
- Sponsor's protocol ID
- Erzurum Atatürk Üniversitesi
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06011096
- Acronym / sponsor ID
- Erzurum Atatürk Üniversitesi
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Bahar GÖBELUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the group with skin-to-skin contact and delayed cord clamping | Experimental | Other: skin-to-skin contact and delayed cord clampingIn this arm, skin-to-skin contact and delayed cord clamping are performed between mother and baby. |
| The group without skin-to-skin contact and early cord clamping | Experimental | Other: avoiding skin-to-skin contact and early cord clampingIn this arm, skin-to-skin contact and delayed cord clamping are not performed between mother and baby. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- for pregnant women
- for newborns
Key exclusion criteria (4 listed)
- Births less than 37 weeks
- Multiparity
- Any complications in the mother or baby
- Removal of the placenta by intervention rather than spontaneous separation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin-to-skin contact and delayed cord clampingPlacental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated with skin-to-skin contact and late cord clamping after delivery. | Other | the group with skin-to-skin contact and delayed cord clamping |
| avoiding skin-to-skin contact and early cord clampingAfter delivery, placental separation time, separation method, amount of postpartum bleeding and postpartum comfort were evaluated without skin-to-skin contact and late cord clamping. | Other | The group without skin-to-skin contact and early cord clamping |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
Related trials for Patient Comfort
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Recruiting
Breathing Meditation and VR Nature Videos in Angiography Patients: Effects on Anxiety, Comfort, and Physiology
Coronary Angiography, Virtual Reality
Enrolling by invitationObservational study
Real-World Validation of A Minimally Disruptive Ambulatory Blood Pressure Monitoring (ABPM) Huawei Smartwatch in Malaysia
Hypertension, Vascular Disease
Recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahar Göbel principal investigator
Midwife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin-to-skin contact and delayed cord clamping and avoiding skin-to-skin contact and early cord clamping in people with Patient Comfort and Postpartum Hemorrhage, run by Bahar GÖBEL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin-to-skin contact and delayed cord clamping affect placental separation time. (time frame: 0-30 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.