NCT04193345

Brief Summary

To compare the different maternal and neonatal impacts of early versus delayed umbilical cord clamping among pregnant preeclamptic patients delivered by cesarean section

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

December 8, 2019

Last Update Submit

February 7, 2022

Conditions

Keywords

Delayed Umbilical Cord ClampingPreeclamptic Patients

Outcome Measures

Primary Outcomes (1)

  • the intra operative maternal blood loss

    To compare the early versus of delayed cord clamping on intra operative blood loss in pregnant patients diagnosed with severe preeclampsia

    24 hours

Secondary Outcomes (2)

  • the neonatal outcome

    4 days

  • The incidence of post partum hemorrhage

    24 hours

Study Arms (2)

Early cord clamping

ACTIVE COMPARATOR

The umbilical cord will be clamped within 15 seconds from delivery of the baby

Other: Documentation of Maternal blood loss and neonatal outcome

Delayed cord clamping

ACTIVE COMPARATOR

The umbilical cord will be clamped after 60 seconds from delivery of the baby

Other: Documentation of Maternal blood loss and neonatal outcome

Interventions

Comparing and monitoring the maternal blood loss and neonatal effect of delayed umbilical cord clamping and early umbilical cord clamping after delivery of the baby durin cesarean delivery in severe preeclampsia

Delayed cord clampingEarly cord clamping

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women candidate for LSCS.
  • Age: 20-40 years old.
  • Maternal severe preeclampsia
  • CS under spinal anesthesia.
  • Singleton pregnancy

You may not qualify if:

  • Fetal death (IUFD).
  • Intrapartum surgical complications ( uterine artery injury or lower segment extension)
  • Medical disorders such as Diabetes mellitus or severe anemia
  • The need for immediate resuscitation like meconium aspiration .
  • Abnormal placentation or placental abruption
  • Liquor abnormalities ; oligo hydramnios
  • Anomalous fetus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine - Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Rashwan A, Eldaly A, El-Harty A, Elsherbini M, Abdel-Rasheed M, Eid MM. Delayed versus early umbilical cord clamping for near-term infants born to preeclamptic mothers; a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Jun 25;22(1):515. doi: 10.1186/s12884-022-04831-8.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 10, 2019

Study Start

January 1, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

February 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations