Trial · NCT00906347

A Trial of Oral Misoprostol for Labor Augmentation

NCT00906347, Phase 4, Completed, University of Texas Southwestern Medical Center; results first posted 2012-11-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial of Oral Misoprostol for Labor Augmentation. Trials, record NCT00906347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00906347

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of Oral Misoprostol for Labor Augmentation
NCT number: NCT00906347
Status: Completed
Phases: Phase 4
Enrollment: 350 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Labor Augmentation
Interventions: Misoprostol, Oxytocin
First posted: 2009-05-21
Last updated: 2012-11-15
Results first posted: 2012-11-07

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Uterine Tachysystole	Up to four hours after administration of study drug	Defined as six contractions in two consecutive 10-minute periods
Secondary	Infant Apgar Score <4	5 minutes after delivery	Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.
Secondary	Umbilical Cord Artery pH <7.1	Obtained at delivery
Secondary	Admission of Neonatal Intensive Care Unit	Until hospital discharge
Secondary	Maternal Chorioamnionitis	During labor	Temperature 38 degrees C or higher in the absence of other sources of infection
Secondary	Maternal Hypovolemia Requiring Blood Transfusion	Until hospital discharge
Secondary	Method of Delivery	At delivery
Secondary	Time Elapsed From Start of Labor Augmentation to Delivery	Initiation of augmentation until delivery

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Uterine Tachysystole	Up to four hours after administration of study drug	Intent to treat	participants	NUMBER
SECONDARY	Infant Apgar Score <4	5 minutes after delivery	Intent to treat	infants	NUMBER
SECONDARY	Umbilical Cord Artery pH <7.1	Obtained at delivery	Intent to treat	infants	NUMBER
SECONDARY	Admission of Neonatal Intensive Care Unit	Until hospital discharge	Intent to treat	infants	NUMBER
SECONDARY	Maternal Chorioamnionitis	During labor	Intent to treat	participants	NUMBER
SECONDARY	Maternal Hypovolemia Requiring Blood Transfusion	Until hospital discharge	Intent to treat	participants	NUMBER
SECONDARY	Method of Delivery	At delivery	Intent to treat	participants	NUMBER
SECONDARY	Time Elapsed From Start of Labor Augmentation to Delivery	Initiation of augmentation until delivery	Intent to treat	minutes	MEDIAN

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Uterine Tachysystole	Misoprostol Augmentation	50	participants
Uterine Tachysystole	Oxytocin Augmentation	41	participants
Infant Apgar Score <4	Misoprostol Augmentation	0	infants
Infant Apgar Score <4	Oxytocin Augmentation	0	infants
Umbilical Cord Artery pH <7.1	Misoprostol Augmentation	3	infants
Umbilical Cord Artery pH <7.1	Oxytocin Augmentation	4	infants
Admission of Neonatal Intensive Care Unit	Misoprostol Augmentation	1	infants
Admission of Neonatal Intensive Care Unit	Oxytocin Augmentation	0	infants
Maternal Chorioamnionitis	Misoprostol Augmentation	28	participants
Maternal Chorioamnionitis	Oxytocin Augmentation	32	participants

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized	STARTED	Misoprostol Augmentation	176
Randomized	STARTED	Oxytocin Augmentation	174
Randomized	COMPLETED	Misoprostol Augmentation	176
Randomized	COMPLETED	Oxytocin Augmentation	174
Randomized	NOT COMPLETED	Misoprostol Augmentation	0
Randomized	NOT COMPLETED	Oxytocin Augmentation	0
Received Study Drug	STARTED	Misoprostol Augmentation	176
Received Study Drug	STARTED	Oxytocin Augmentation	174
Received Study Drug	COMPLETED	Misoprostol Augmentation	136
Received Study Drug	COMPLETED	Oxytocin Augmentation	143

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Need for emergent cesarean delivery secondary to nonreassuirng fetal heart rate	Pregnancy, puerperium and perinatal conditions	Misoprostol Augmentation	1	176	1
serious	Need for emergent cesarean delivery secondary to nonreassuirng fetal heart rate	Pregnancy, puerperium and perinatal conditions	Oxytocin Augmentation	2	174	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Misoprostol Augmentation
Total, all-cause mortality	Oxytocin Augmentation
Total, other adverse events	Misoprostol Augmentation	0	176
Total, other adverse events	Oxytocin Augmentation	0	174
Total, serious adverse events	Misoprostol Augmentation	1	176
Total, serious adverse events	Oxytocin Augmentation	2	174

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22105254	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Misoprostol Augmentation vs Oxytocin Augmentation: Maternal Chorioamnionitis	Trial comparisons
Misoprostol Augmentation vs Oxytocin Augmentation: Maternal Hypovolemia Requiring Blood Transfusion	Trial comparisons
Misoprostol Augmentation vs Oxytocin Augmentation: Uterine Tachysystole	Trial comparisons
Misoprostol Augmentation vs Oxytocin Augmentation: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00906347

GET https://conductscience.org/api/trials/v1/NCT00906347/results?page=2

API reference For AI assistants