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A Trial of Oral Misoprostol for Labor Augmentation

NCT ID: NCT00906347

Last Updated: 2012-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Augmentation

Keywords

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Labor augmentation Oral misoprostol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxytocin augmentation

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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

Misoprostol augmentation

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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

Interventions

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Misoprostol

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

Intervention Type DRUG

Oxytocin

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

Intervention Type DRUG

Other Intervention Names

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Cytotec Pitocin

Eligibility Criteria

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Inclusion Criteria

* 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
* 5 or fewer contractions in a 10 minute period
* English or Spanish speaking patient

Exclusion Criteria

* 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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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April Bleich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Kenneth Leveno, MD

Role: STUDY_DIRECTOR

University of Texas Southwestern Medical Center

Locations

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The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22105254 (View on PubMed)

Other Identifiers

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102008-030

Identifier Type: -

Identifier Source: org_study_id