NCT00473707

Brief Summary

The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3.9 years

First QC Date

May 14, 2007

Last Update Submit

April 11, 2023

Conditions

Postpartum Hemorrhage

Keywords

Third stage of labor

Outcome Measures

Primary Outcomes (1)

  • Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater

    reported immediately after delivery

Secondary Outcomes (4)

  • Mean change in hematocrit from before delivery to the first postpartum day

    24 hours

  • Rate of maternal blood transfusion

    48 hours

  • Duration of the third stage of labor

    60 minutes

  • Incidence of retained placenta

    30 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage

Procedure: Active management of the third stage of laborDrug: Oxytocin and gentle cord traction with fundal massage

2

OTHER

Expectant management of the third stage of labor

Procedure: Expectant management of the third stage of laborDrug: Oxytocin

Interventions

Active management of the third stage of laborPROCEDURE

standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage

1
Expectant management of the third stage of laborPROCEDURE

standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun

2
Oxytocin and gentle cord traction with fundal massageDRUG

standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage

1
OxytocinDRUG

standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun

2

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton gestation
  • Cephalic presentation
  • \>37 weeks gestation
  • \>16 years of age

You may not qualify if:

  • Multiple gestation
  • Breech presentation
  • Blood dyscrasias
  • Multiparous females Para \>5
  • Placenta previa
  • Patients on anticoagulants
  • Previous history of postpartum hemorrhage
  • IUFD
  • Non-reassuring fetal heart rate pattern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Danielle E Castagnola, MD

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

August 1, 2002

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

US(1)