NCT00906347

Brief Summary

This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2008

Typical duration for phase_4

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

December 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 7, 2012

Completed
Last Updated

November 15, 2012

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

May 19, 2009

Results QC Date

October 5, 2012

Last Update Submit

November 8, 2012

Conditions

Labor Augmentation

Keywords

Labor augmentationOral misoprostol

Outcome Measures

Primary Outcomes (1)

  • Uterine Tachysystole

    Defined as six contractions in two consecutive 10-minute periods

    Up to four hours after administration of study drug

Secondary Outcomes (7)

  • Infant Apgar Score <4

    5 minutes after delivery

  • Umbilical Cord Artery pH <7.1

    Obtained at delivery

  • Admission of Neonatal Intensive Care Unit

    Until hospital discharge

  • Maternal Chorioamnionitis

    During labor

  • Maternal Hypovolemia Requiring Blood Transfusion

    Until hospital discharge

  • +2 more secondary outcomes

Study Arms (2)

Oxytocin augmentation

ACTIVE COMPARATOR

Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.

Drug: Oxytocin

Misoprostol augmentation

ACTIVE COMPARATOR

Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.

Drug: Misoprostol

Interventions

MisoprostolDRUG

75 micrograms orally every 4 hours for up to 2 doses.

Also known as: Cytotec
Misoprostol augmentation
OxytocinDRUG

Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital

Also known as: Pitocin
Oxytocin augmentation

Eligibility Criteria

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

You may qualify if:

  • Clinical decision to augment labor
  • Gestational age \> than or equal to 36 weeks
  • Singleton gestation
  • Cephalic presentation
  • Reassuring fetal heart rate tracing
  • Cervical dilation between 4 and 8 cm
  • Ruptured membranes with clear amniotic fluid
  • Intrauterine pressure catheter in place
  • Less than 200 MVUs in a 10 minute period
  • or fewer contractions in a 10 minute period
  • English or Spanish speaking patient

You may not qualify if:

  • Non-reassuring fetal heart rate tracing at time of enrollment
  • Meconium stained amniotic fluid
  • Previous uterine incision
  • Maternal fever (defined as greater than 37.9 C)
  • Known fetal anomalies
  • Placenta previa or unexplained vaginal bleeding
  • Estimated fetal weight of 4,500 grams or more
  • Abnormal maternal bony pelvis
  • Grandmultiparity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • Bleich AT, Villano KS, Lo JY, Alexander JM, McIntire DD, Leveno KJ. Oral misoprostol for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2011 Dec;118(6):1255-1260. doi: 10.1097/AOG.0b013e318236df5b.

    PMID: 22105254DERIVED

MeSH Terms

Interventions

MisoprostolOxytocin

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. April Bleich
Organization
University of Texas Southwestern Medical Center
april.bleich@gmail.com
214-648-2316

Study Officials

  • April Bleich, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

  • Kenneth Leveno, MD

    University of Texas Southwestern Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

December 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 15, 2012

Results First Posted

November 7, 2012

Record last verified: 2009-05

Locations

US(1)