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

NCT ID: NCT01634854

Last Updated: 2017-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.

Conditions

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Induction of Labor in Multiparous Women

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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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

Group Type ACTIVE_COMPARATOR

Vaginal Misoprostol

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Intravenous Oxytocin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Cytotec Pitocin

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Angela Wilson-Liverman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Wilson-Liverman, MSN, CNM

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Countries

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United States

References

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Chaudhuri S, Mitra SN, Banerjee PK, Biswas PK, Bhattacharyya S. Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: a randomized comparative trial. J Obstet Gynaecol Res. 2011 Nov;37(11):1564-71. doi: 10.1111/j.1447-0756.2011.01575.x. Epub 2011 Jun 16.

Reference Type BACKGROUND
PMID: 21676083 (View on PubMed)

Olagbuji BN, Ezeanochie MC, Kubeyinje W, Dunsin T, Ande AB. Pregnancy outcome following induction of labor with intravaginal misoprostol for decreased fetal movements at term. J Matern Fetal Neonatal Med. 2011 Oct;24(10):1225-7. doi: 10.3109/14767058.2011.572309. Epub 2011 Apr 20.

Reference Type BACKGROUND
PMID: 21506657 (View on PubMed)

Saeed GA, Fakhar S, Nisar N, Alam AY. Misoprostol for term labor induction: a randomized controlled trial. Taiwan J Obstet Gynecol. 2011 Mar;50(1):15-9. doi: 10.1016/j.tjog.2009.08.001.

Reference Type BACKGROUND
PMID: 21482368 (View on PubMed)

Shakya R, Shrestha J, Thapa P. Safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. JNMA J Nepal Med Assoc. 2010 Jan-Mar;49(177):33-7.

Reference Type BACKGROUND
PMID: 21180218 (View on PubMed)

Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.

Reference Type BACKGROUND
PMID: 20927722 (View on PubMed)

Crane JM, Butler B, Young DC, Hannah ME. Misoprostol compared with prostaglandin E2 for labour induction in women at term with intact membranes and unfavourable cervix: a systematic review. BJOG. 2006 Dec;113(12):1366-76. doi: 10.1111/j.1471-0528.2006.01111.x.

Reference Type BACKGROUND
PMID: 17081181 (View on PubMed)

Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57.

Reference Type BACKGROUND
PMID: 16135593 (View on PubMed)

Li XM, Wan J, Xu CF, Zhang Y, Fang L, Shi ZJ, Li K. Misoprostol in labour induction of term pregnancy: a meta-analysis. Chin Med J (Engl). 2004 Mar;117(3):449-52.

Reference Type BACKGROUND
PMID: 15043790 (View on PubMed)

Other Identifiers

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120660

Identifier Type: -

Identifier Source: org_study_id