NCT06011096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 9, 2023

Last Update Submit

August 23, 2023

Conditions

Patient ComfortPostpartum HemorrhageMidwiferyPlacenta

Keywords

skin-to-skin contactplacental separation timePostpartum Comfortplacental separation methoddelayed clamping of the umbilical cordmidwife

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    2 hours

Study Arms (2)

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.

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.

Other: avoiding skin-to-skin contact and early cord clamping

Interventions

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.

the group with skin-to-skin contact and delayed cord clamping
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.

The group without skin-to-skin contact and early cord clamping

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimiparous women giving birth vaginally
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • for pregnant women
  • Those who agreed to participate in the research
  • years old
  • Firstborn (nulliparous)
  • Have 37-42 weeks of pregnancy
  • The baby in head presentation
  • 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

You may not qualify if:

  • Births less than 37 weeks
  • Multiparity
  • Any complications in the mother or baby
  • Removal of the placenta by intervention rather than spontaneous separation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum City Hospital

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Bahar Göbel

    Midwife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 25, 2023

Study Start

November 2, 2022

Primary Completion

June 10, 2023

Study Completion

August 9, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

TU(1)