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"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"

NCT07701434 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-14

No results posted yet for this study

Summary

This clinical trial aims to evaluate the effects of a cord clamping bundle developed through the Delphi method on maternal and neonatal outcomes. The study population consists of primiparous women with singleton term pregnancies (37-42 weeks of gestation) who undergo vaginal delivery, along with their healthy newborns.

The primary research questions are:

Does the Delphi-based cord clamping bundle improve maternal and neonatal physiological outcomes? Does the Delphi-based cord clamping bundle enhance mother-infant bonding and breastfeeding success?

Comparison Group:

Researchers will compare the intervention group, in which the cord clamping bundle is implemented, with the control group receiving routine clinical care to determine the effects of the intervention on maternal and neonatal outcomes.

Participant Involvement:

Participants will provide written and verbal informed consent and complete a personal information form. Following delivery, participants will receive either the cord clamping bundle intervention or routine care according to their assigned group. Data collection will be conducted within the first 24 hours postpartum and will include:

Maternal and neonatal physiological parameters Breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale Amount of postpartum bleeding Placental separation time Time to initiation of breastfeeding Length of hospital stay after delivery.

Conditions

  • Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes

Interventions

OTHER

Cord Clamping Bundle

A standardized cord clamping bundle developed through the Delphi technique based on expert consensus. The intervention includes preparation of sterile materials, delayed umbilical cord clamping until cord pulsations cease (at least 1-3 minutes after birth), sterile cord clamping and cutting, and maintenance of dry cord care.

OTHER

Routine Cord Clamping Care

Routine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    collaborator OTHER

  • Elif MARANGOZ

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-08-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701434 on ClinicalTrials.gov