NCT01634854

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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

July 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 28, 2017

Completed
Last Updated

December 19, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

July 2, 2012

Results QC Date

April 14, 2017

Last Update Submit

November 20, 2017

Conditions

Induction of Labor in Multiparous Women

Outcome Measures

Primary Outcomes (1)

  • Time From Induction to Vaginal Delivery

    Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.

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

Secondary Outcomes (6)

  • Neonatal APGAR Scores

    At 1 minute and 5 minutes after delivery

  • Neonatal Weight at Delivery

    Immediately following delivery

  • Maternal Delivery Outcomes

    Through discharge from hospital

  • Maternal Satisfaction With Labor

    6 weeks post-partum

  • Number of Participants With Excessive Uterine Activity Necessitating Treatment

    Measured from initiation of medication until delivery time

  • +1 more secondary outcomes

Study Arms (2)

Vaginal Misoprostol

ACTIVE COMPARATOR

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

Drug: Vaginal Misoprostol

Intravenous Oxytocin

ACTIVE COMPARATOR

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

Drug: Intravenous Oxytocin

Interventions

Vaginal MisoprostolDRUG

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

Also known as: Cytotec
Vaginal Misoprostol
Intravenous OxytocinDRUG

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

Also known as: Pitocin
Intravenous Oxytocin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 21676083BACKGROUND

  • 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.

    PMID: 21506657BACKGROUND

  • 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.

    PMID: 21482368BACKGROUND

  • 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.

    PMID: 21180218BACKGROUND

  • 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.

    PMID: 20927722BACKGROUND

  • 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.

    PMID: 17081181BACKGROUND

  • 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.

    PMID: 16135593BACKGROUND

  • 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.

    PMID: 15043790BACKGROUND

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
Angela Wilson-Liverman CNM
Organization
Vanderbilt University Medical Center
angela.wilson-liverman@vanderbilt.edu

Study Officials

  • Angela Wilson-Liverman, MSN, CNM

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2012

First Posted

July 6, 2012

Study Start

July 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

December 19, 2017

Results First Posted

June 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share