Trial · Interventional

CompletedNot applicableResults postedRegistry data

A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor

NCTNCT01634854Other id120660

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 130 participants (actual)
Sponsor: Vanderbilt University Medical Center · Other
Design: Randomized · Open label (no masking)
Countries: Not stated
Start: Jul 2012
Primary completion: May 2014
Completion: May 2014
First posted: 6 Jul 2012 (estimated)
Last update posted: 19 Dec 2017
Conditions: Induction of Labor in Multiparous Women

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015

N/A
A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor
NCT01634854
Jul 2012 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.

Interventions

Vaginal MisoprostolDrug
Intravenous OxytocinDrug

Arms2

Active comparator
Vaginal Misoprostol
Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Active comparator
Intravenous Oxytocin
2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous

Primary outcomes1

Outcomes the sponsor listed as primary.

Time From Induction to Vaginal Delivery
Time frame · Time to delivery in minutes from initiation of medication, up to 24 hours
Registry description
Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.

Secondary outcomes(6)

Neonatal APGAR Scores
Time frame · At 1 minute and 5 minutes after delivery
Registry description
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.
Neonatal Weight at Delivery
Time frame · Immediately following delivery
Registry description
Neonatal Weight
Maternal Delivery Outcomes
Time frame · Through discharge from hospital
Registry description
Maternal delivery outcomes
Maternal Satisfaction With Labor
Time frame · 6 weeks post-partum
Number of Participants With Excessive Uterine Activity Necessitating Treatment
Time frame · Measured from initiation of medication until delivery time
Registry description
Number of patients receiving terbutaline during labor for uterine tachysytole
NICU Admission and APGAR Less Than 7 at 5 Minutes
Time frame · Through discharge from hospital
Registry description
NICU admission and APGAR less than 7 at 5 minutes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Time to delivery in minutes from initiation of medication, up to 24 hours

Time From Induction to Vaginal Delivery

Group	Value (minutes)
Vaginal Misoprostol	800
Intravenous Oxytocin	693

Secondary and other outcome results(6)

Secondary outcomeMedian· At 1 minute and 5 minutes after delivery

Neonatal APGAR Scores

Group	Value (number)
Vaginal Misoprostol	8
Intravenous Oxytocin	8

Secondary outcomeMedian· Immediately following delivery

Neonatal Weight at Delivery

Group	Value (grams)
Vaginal Misoprostol	3500
Intravenous Oxytocin	3415

Secondary outcomeCount of participants· Through discharge from hospital

Maternal Delivery Outcomes

Group	Value (Participants)
Vaginal Misoprostol	56
Intravenous Oxytocin	48

Secondary outcome· 6 weeks post-partum

Maternal Satisfaction With Labor

Group	Value
Vaginal Misoprostol	not posted
Intravenous Oxytocin	not posted

Secondary outcomeCount of participants· Measured from initiation of medication until delivery time

Number of Participants With Excessive Uterine Activity Necessitating Treatment

Group	Value (Participants)
Vaginal Misoprostol	9
Intravenous Oxytocin	4

Secondary outcomeCount of participants· Through discharge from hospital

NICU Admission and APGAR Less Than 7 at 5 Minutes

Group	Value (Participants)
Vaginal Misoprostol	8
Intravenous Oxytocin	4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Vaginal MisoprostolDosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal	0 / 62	0 / 62	0 / 62
Intravenous Oxytocin2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous	0 / 59	0 / 59	0 / 59

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

More studies

5 studies on this page

Indexing hint: Meta-analysis (pooled) · 2010

Vaginal misoprostol for cervical ripening and induction of labour.

Hofmeyr et al. 2010The Cochrane database of systematic reviewscited by 124

PMID 20927722PMC7061246DOI 10.1002/14651858.cd000941.pub2PUB-20927722

Rights unknown

Source link

Indexing hint: Randomized controlled trial · 2010

Safety and efficacy of misoprostol and dinoprostone as cervical ripening agents.

Shakya et al. 2010JNMA; journal of the Nepal Medical Associationcited by 6

PMID 21180218DOI 10.31729/jnma.132PUB-21180218

Full text at the publisher

Publisher page

Indexing hint: Meta-analysis (pooled) · 2006

Misoprostol compared with prostaglandin E2 for labour induction in women at term with intact membranes and unfavourable cervix: a systematic review.

Crane et al. 2006BJOG : an international journal of obstetrics and gynaecologycited by 33

PMID 17081181DOI 10.1111/j.1471-0528.2006.01111.xPUB-17081181

Full text at the publisher

Publisher page

Indexing hint: Meta-analysis (pooled) · 2005

Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis.

Lin et al. 2005Obstetrics and gynecologycited by 34

PMID 16135593DOI 10.1097/01.aog.0000172425.56840.57PUB-16135593

Full text at the publisher

Publisher page

Indexing hint: Meta-analysis (pooled) · 2004

Misoprostol in labour induction of term pregnancy: a meta-analysis.

Li et al. 2004Chinese medical journalcited by 8

PMID 15043790PUB-15043790

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Clinical candidate for labor induction utilizing either misoprostol or oxytocin * Greater than or equal to 18 years of age * Multiparous * Singleton gestation; * Greater than 37 weeks gestation; * Cephalic presentation Exclusion Criteria: * Any clinical contraindication to misoprostol as induction drug * Age less than 18 years * Contraindication to vaginal birth * Nonreassuring fetal heart rate tracing * Prior uterine surgery * Active labor * Active maternal bleeding * Chorioamnionitis (infection)

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