Impact of Umbilical Cord Clamping Time on Infant Anemia

NCT ID: NCT04463485

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-21
• Study Completion Date: 2018-12-30

Brief Summary

This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia.

Detailed Description

This study is an experimental, randomized controlled study. The sample of the study consisted of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In this study, "Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant Anemia" was used as a data collection tool. In the intervention group waited 60 seconds for umbilical cord clamping in the second stage of labor, in the control group the umbilical cord was clamped in the first 15 seconds. For the data of the first stage of the study, the neonatal hematocrit and bilirubin measurements and the need for phototherapy due to hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study, data on anaemia screening performed in family medicine at the end of the fourth month of birth were examined. Statistical analysis of the data from the study was performed using IBM SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of the data with a normal distribution. The level of statistical significance was determined as p<0.05.

Conditions

Third Stage of Labor; Healthy; Umbilical Cord Clamping Time; Infant Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Delayed Clamping

The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.

Group Type: EXPERIMENTAL

Delayed Clamping

Intervention Type: PROCEDURE

Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.

Early Clamping

No interventions have been assigned.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Delayed Clamping

Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Apply for normal birth
• Singleton pregnancy and live fetus
• Cephalic presentation
• Estimated birth weight between 2500-4000 grams
• Birth rates <5
• Women who received iron support during pregnancy
• Haemoglobin level ≥ 11 gr/dL
• No systemic disease or pregnancy complication that may pose a risk for postpartum bleeding.
• Neonates who don't need for resuscitation after birth
• Babies who did not receive iron supplements up to the 4th month after birth were included.

Exclusion Criteria

• Pregnant women who refuse to participate in the research
• Neonates who need for resuscitation after birth
• Babies who receive iron supplements up to the 4th month after birth were excluded.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Sevil Güner

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birsen Saydam

Role: STUDY_DIRECTOR

Ege University

Locations

Ege University Medical Hospital Obstetric and Gynecology Department

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Delayed Cord Clamping RCT

Identifier Type: -

Identifier Source: org_study_id